The Effectiveness of an eHealth Family-Based Intervention Program in Patients With Uncontrolled Type 2 Diabetes Mellitus (T2DM) in the Community Via WeChat: Randomized Controlled Trial

Background Intervention based on family support and risk perception can enhance type 2 diabetes mellitus (T2DM) patients’ self-care activities. In addition, eHealth education is considered to improve family members’ support for patients with T2DM. However, there is little evidence from rigorously designed studies on the effectiveness of an intervention combining these approaches. Objective This randomized controlled trial (RCT) aimed to assess the effectiveness of an eHealth family-based health education intervention for patients with T2DM to improve their glucose control, risk perception, and self-care behaviors. Methods This single-center, 2-parallel-group RCT was conducted between 2019 and 2020. Overall, 228 patients were recruited from Jiading District, Shanghai, and randomly divided into intervention and control groups. The intervention group received an eHealth family intervention based on community management via WeChat, whereas the control group received usual care. The primary outcome was the glycated hemoglobin (HbA1c) level of the patients with T2DM, and the secondary outcomes were self-management behavior (general and specific diet, exercise, blood sugar testing, foot care, and smoking), risk perception (risk knowledge, personal control, worry, optimism bias, and personal risk), and family support (supportive and nonsupportive behaviors). A 2-tailed paired-sample t test was used to compare the participants at baseline and follow-up within the control and intervention groups. An analysis of covariance was used to measure the intervention effect. Results In total, 225 patients with T2DM were followed up for 1 year. After intervention, they had significantly lower HbA1c values (β=–.69, 95% CI –0.99 to –0.39; P<.001). They also had improved general diet (β=.60, 95% CI 0.20 to 1.00; P=.003), special diet (β=.71, 95% CI 0.34 to 1.09; P<.001), blood sugar testing (β=.50, 95% CI 0.02 to 0.98; P=.04), foot care (β=1.82, 95% CI 1.23 to 2.42; P<.001), risk knowledge (β=.89, 95% CI 0.55 to 1.24; P<.001), personal control (β=.22, 95% CI 0.12 to 0.32; P<.001), worry (β=.24, 95% CI 0.10 to 0.39; P=.001), optimism bias (β=.26, 95% CI 0.09 to 0.43; P=.003), and supportive behaviors (β=5.52, 95% CI 4.03 to 7.01; P<.001). Conclusions The eHealth family-based intervention improved glucose control and self-care activities among patients with T2DM by aiding the implementation of interventions to improve T2DM risk perceptions among family members. The intervention is generalizable for patients with T2DM using health management systems in community health centers. Trial Registration Chinese Clinical Trial Registry ChiCTR1900020736; https://www.chictr.org.cn/showprojen.aspx?proj=31214

Is this a full powered effectiveness trial or a pilot/feasibility trial? * Manuscript tracking number * If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR. If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title yes Other: subitem not at all important 1 2 3 4 5 essential 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study an eHealth family-based intervention program via WeChat

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
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Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This study is an ehealth intervention via WeChat (WeChat Official Account) so that this section is not applicable for this study.
You're editing your response. Sharing this URL allows others to also edit your response. 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial C l e a r s e l e c t i o n Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study patients with uncontrolled type 2 diabetes mellitus (T2DM) You're editing your response. Sharing this URL allows others to also edit your response. Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study public health; type 2 diabetes mellitus; intervention; randomized controlled trial; community health center You're editing your response. Sharing this URL allows others to also edit your response.

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subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) C l e a r s e l e c t i o n Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This single-center, two-parallel-group RCT was conducted between 2019 and 2020. Overall, 228 patients were recruited from Jiading District, Shanghai, and randomly divided into the intervention and control groups. The intervention group received an eHealth family intervention based on community management via WeChat, whereas the control group received usual care.
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subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Overall, 228 patients were recruited from Jiading District, Shanghai, and randomly divided into the intervention and control groups.
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subitem not at all important 1 2 3 4 5 essential 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) C l e a r s e l e c t i o n Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study In total, 225 patients were followed up for 1 year.
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The primary outcomes of this study are positive so that this section is not applicable for this study.
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subitem not at all important 1 2 3 4 5 essential 2a-i) Problem and the type of system/solution Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) C l e a r s e l e c t i o n Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study aimed to develop an eHealth family-based intervention program including knowledge, attitude, and behaviors and validate whether the intervention can improve glucose control levels for T2DM patients registered in community health centers through a rigorously designed trial.
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The details were shown in the background of introduction.
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METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study aimed to develop an eHealth family-based intervention program including knowledge, attitude, and behaviors and validate whether the intervention can improve glucose control levels for T2DM patients registered in community health centers through a rigorously designed trial.
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study we conducted a single-center, two-parallel-group randomized controlled trial Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. During the process of intervention implementation, all participants still in the initial groups. You're editing your response. Sharing this URL allows others to also edit your response.

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subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants 3b-i) Bug fixes, Downtimes, Content Changes Bug xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have in uenced study design such as staff changes, system failures/downtimes, etc. Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. Before conducting this randomized controlled trial, the study has discussed with T2DM-related experts and community health service providers. The intervention tool is shaped in accordance with knowledge-attitude-practice (KAP) model and Helath Belief Model (HBM).
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subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the participants of methods.

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed.
C l e a r s e l e c t i o n Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. To make participants obtain correct and reasonable information about T2DM, the study developed intervention tool based on literature, guideline, textbooks about T2DM.
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subitem not at all important 1 2 3 4 5 essential 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these.
C l e a r s e l e c t i o n Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study According to the National Standard for Basic Public Health Services [14], community health service centers should maintain correspondence with the patients and determine the prevalence of diabetes. This randomized control trial was conducted in the central area of Jiading District, which includes two community health service centers, Jiading Town Community Health Service Center and Juyuan New District Community Health Service Center, where 3,874 individuals with diabetes were registered in the community health service center. Of 1,650 individuals with HbA1c values, 879 presented values over 7.0%.
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subitem not at all important 1 2 3 4 5 essential 4b) Settings and locations where the data were collected 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
C l e a r s e l e c t i o n Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study We screened reasonable T2DM patients who registered in the community helth service system. Then, we connected with them via community health workers and gathered them to receive the statement of research team .
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subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study According to the National Standard for Basic Public Health Services [14], community health service centers should maintain correspondence with the patients and determine the prevalence of diabetes. This randomized control trial was conducted in the central area of Jiading District, which includes two community health service centers, Jiading Town Community Health Service Center and Juyuan New District Community Health Service Center, where 3,874 individuals with diabetes were registered in the community health service center. Of 1,650 individuals with HbA1c values, 879 presented values over 7.0%.

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
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subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. The study collected the data of outcomes by offline questionnaires. This work completed by research team members. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Mao was responsible for generating a random allocation sequence, and the community health center enrolled participants and assigned them to an intervention group or control group.

4b-ii) Report how institutional affiliations are displayed
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5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
C l e a r s e l e c t i o n Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. In this study, we did not mention names, credential, affiliations of the developers, sponsors, and owners.
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subitem not at all important 1 2 3 4 5 essential 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
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Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. The study conducted intervention via WeChat, which has been used by people daily life, as a popular and free application.
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subitem not at all important 1 2 3 4 5 essential

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. The study conducted intervention via WeChat, which has been used by people daily life, as a popular and free application.
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subitem not at all important 1 2 3 4 5 essential 5-iv) Quality assurance methods Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Before the implementation of intervention, the study connected with community health service providers and cooperated with them. During the process of intervention implementation, some research team members served as darta collectors and situation monitors. All of them were trained uniformly about the aim and contents of this study. During the process of data input, two research team members input data at the same time, who have been trained.
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subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study.
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subitem not at all important 1 2 3 4 5 essential

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
C l e a r s e l e c t i o n Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study.
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subitem not at all important 1 2 3 4 5 essential

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
C l e a r s e l e c t i o n Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the intervention tool and intervention process of methods.
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subitem not at all important 1 2 3 4 5 essential 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the intervention process of methods.
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subitem not at all important 1 2 3 4 5 essential

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
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Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study During phase 2 (from March 1 to May 31, 2019), the study regularly delivered the 38 articles above (about 3 articles per week). Based on National Standard for Basic Public Health Services, all T2DM patients should receive on-site health education once per three months.
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subitem not at all important 1 2 3 4 5 essential

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
C l e a r s e l e c t i o n Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the intervention process of methods.
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subitem not at all important 1 2 3 4 5 essential 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
C l e a r s e l e c t i o n Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study During phase 2 (from March 1 to May 31, 2019), the study regularly delivered the 38 articles above (about 3 articles per week). A-level articles were sent one-to-one via the WeChat official account and messages. B-level articles were sent through individual WeChat moments forwarding. C-level articles were sent through the WeChat official account release (Multimedia Appendix 3).
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subitem not at all important 1 2 3 4 5 essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xii) Describe any co-interventions (incl. training/support) Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. C l e a r s e l e c t i o n Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the intervention process of methods.
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subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the outcomes measures of methods. You're editing your response. Sharing this URL allows others to also edit your response.

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subitem not at all important 1 2 3 4 5 essential 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
C l e a r s e l e c t i o n Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Intervention articles were released regularly (about 3 articles per week).
In-person health education were conducted once per three months.
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subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
C l e a r s e l e c t i o n

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text This eHealth intervention was implemented based on WeChat official account so that we can learn about the reading situation of each article in real time through the background monitoring.
Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not appplicable for this study. No changesto trial outcomes after the trial commenced. You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the sample size calculation of methods.
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8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. The process of intervention don't refer to some aspects taht may have an adverse impact on participants.
Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study numbered participants via random number table. Then, the study ranked them in ascending order and they were allocated in intervention group and control group in the ratio of 1:1.
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The type of randomazation at the level of individuals.
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9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The study numbered participants via random number table. Then, the study ranked them in ascending order and they were allocated in intervention group and control group in the ratio of 1:1.
Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Mao was responsible for generating a random allocation sequence, and the community health center enrolled participants and assigned them to an intervention group or control group You're editing your response. Sharing this URL allows others to also edit your response.

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subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
C l e a r s e l e c t i o n Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. Notably, because the intervention is an ehealth intervention, participants knew they received this kind of intervention when they provided informed consent; thus, the study participants could not be blinded.
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subitem not at all important 1 2 3 4 5 essential 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
C l e a r s e l e c t i o n Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study.
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12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Both intervention group and control group, they received usual care, such in-person health intervention.
Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the statistical analysis of methods.
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subitem not at all important 1 2 3 4 5 essential 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
C l e a r s e l e c t i o n Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The quality of data collection and input is good. There have not missing values in database.
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X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Changes between the baseline and follow-up period in the intervention and control groups were measured with 95% confidence intervals at the baseline and 12 months. Finally, since HbA1c was the primary outcome, we further analyzed a subgroup according to sex to explore whether the result differed between males and females. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicabale for this study. The study collected informed consents after the on-site research programme statement directly.

X26-i) Comment on ethics committee approval
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subitem not at all important 1 2 3 4 5 essential RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) C l e a r s e l e c t i o n

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. The process of this study did not refer to some procedures or aspects that may harm to participants.
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13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study From March 1, 2019, to March 1, 2020. In total, 225 patients (113 patients in the intervention group and 112 patients in the control group) completed this 1-year intervention study. Three participants (one in the intervention group and two in the control group) were lost to followup. For each group, the analysis of the number of participants is always in the original assigned groups. This process is shown in Figure 2.
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study From March 1, 2019, to March 1, 2020. In total, 225 patients (113 patients in the intervention group and 112 patients in the control group) completed this 1-year intervention study. Three participants (one in the intervention group and two in the control group) were lost to followup. For each group, the analysis of the number of participants is always in the original assigned groups. This process is shown in Figure 2.
You're editing your response. Sharing this URL allows others to also edit your response. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in Figure 2.
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subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study From March 1, 2019, to March 1, 2020. In total, 225 patients (113 patients in the intervention group and 112 patients in the control group) completed this 1-year intervention study. Three participants (one in the intervention group and two in the control group) were lost to followup. For each group, the analysis of the number of participants is always in the original assigned groups. This process is shown in Figure 2.

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" C l e a r s e l e c t i o n Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study.
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14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each
group NPT: When applicable, a description of care providers (case volume, quali cation, expertise, etc.) and centers (volume) in each group Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study. The study did not end or stop.
Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details in Table 1 and 2.
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subitem not at all important 1 2 3 4 5 essential 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 15-i) Report demographics associated with digital divide issues In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
C l e a r s e l e c t i o n Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details in Table 1 and 2.
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subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.
C l e a r s e l e c t i o n Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study For each group, number of participants included in each analysis by original assigned groups.
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subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
C l e a r s e l e c t i o n Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in Table 1 and 2.
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in Table 2. You're editing your response. Sharing this URL allows others to also edit your response.

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subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a).
C l e a r s e l e c t i o n Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in Table 1 and 2.
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18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in Table 1 and 2.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in Table 2.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
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19) All important harms or unintended effects in each group
(for speci c guidance see CONSORT for harms) Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in Table 2.
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study.
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study

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The details were shown in the interview of results.
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subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
C l e a r s e l e c t i o n Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The details were shown in the principal findings and comparison with prior works of discussions.
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study First, the sample size was small and only included patients enrolled in one city. Future studies should enroll larger sample sizes and include multi-sources.
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20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
C l e a r s e l e c t i o n Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study However, this study also has some limitations. First, the sample size was small and only included patients enrolled in one city. Future studies should enroll larger sample sizes and include multi-sources. Second, the intervention time was 1 year, and we did not continuously follow up with the T2DM patients and their family members. Consequently, we could only conclude whether the intervention was effective over a period of time but could not confirm its long-term effects. Finally, participant compliance could not be documented comprehensively, such as how long or how often T2DM patients' family members read intervention articles.
You're editing your response. Sharing this URL allows others to also edit your response. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The eHealth family-based intervention can improve T2DM patients' glucose control and selfcare activities by implementing interventions based on risk perception about T2DM for family members to improve family support. The intervention is generalizable for T2DM patients based on the health management system in community health centers.
You're editing your response. Sharing this URL allows others to also edit your response. Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
C l e a r s e l e c t i o n Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This section is not applicable for this study.
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24)
Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item) Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study ChiCTR1900020736. Registered January 15, 2019.
Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study You're editing your response. Sharing this URL allows others to also edit your response.

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subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist yes, major changes yes, minor changes no X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
C l e a r s e l e c t i o n Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The authors declare no conflict of interest.
As a result of using this checklist, did you make changes in your manuscript? * You're editing your response. Sharing this URL allows others to also edit your response. What were the most important changes you made as a result of using this checklist?
The most important changes are in introduction.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * About 8 hours is used to finish this checklist and revise manuscript.
As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document C l e a r s e l e c t i o n

Any other comments or questions on CONSORT EHEALTH
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