Delivering a Post-Partum Weight Loss Intervention via Facebook or In-Person Groups: Protocol for a Randomized Feasibility Pilot Trial

Background Postpartum weight retention contributes to long-term weight gain and obesity for many women. Lifestyle interventions with numerous visits are logistically challenging for many postpartum women. Delivering a lifestyle intervention via social media may overcome logistic challenges to participation in in-person weight loss programs. Objective The objective of this study is to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups with 72 postpartum women with overweight or obesity. Methods Women with overweight or obesity who are 8 weeks to 12 months postpartum (N=72) will be recruited from the Hartford, Connecticut community. Eligible participants must also own an iPhone or Android smartphone and be an active Facebook user. Participants will receive a 6-month postpartum weight loss intervention based on the Diabetes Prevention Program lifestyle intervention and adapted for postpartum women. Participants will be randomized to receive the intervention via a private Facebook group or in-person group meetings. Assessments will occur at baseline, weekly during the intervention, at 6 months (at the end of the intervention), and at 12 months. Primary feasibility outcomes are recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures including measurement of costs to deliver and receive the intervention. We will describe 6- and 12-month weight loss as an exploratory outcome. Results Recruitment began in September 2018. The first wave of the intervention began in February 2019, and the second wave of the intervention is expected to begin in fall 2019. We anticipate completing follow-up assessments in fall 2020, and results will be analyzed at that time. Conclusions Results will inform the design of a large randomized controlled trial to assess whether delivering a postpartum weight loss intervention via Facebook is noninferior for weight loss and more cost-effective than delivering the intervention via traditional in-person groups. International Registered Report Identifier (IRRID) DERR1-10.2196/15530

1 R34 HL136979-01 3 ZHL1 CSR-G (F1) WARING, M intervention. If efficacious and cost-effective, our Facebook-delivered intervention leads naturally to strategies for scaling up for widespread impact. (End of Abstract)

CRITIQUE 1:
Significance: 2 Investigator(s): 1 Innovation: 3 Approach: 2 Environment: 1 Overall Impact: The applicants have chosen an important area for study. One concern is that they propose a non-inferiority trial to be compared to an approach that is described as only modestly effective. This is especially important as many women enter pregnancy obese and ultimately need more substantial postpartum weight management. On the other hand, the proposed approach using Facebook may be less costly and more convenient for postpartum mothers.
The applicants have clearly identified information that is needed to design and complete the subsequent trial. One aspect that is not as well developed is the cost-effectiveness component. The investigative team and the environment appear to be well suited to the proposed research.

Significance: Strengths
 Postpartum weight gain and maintenance of that weight gain has important ultimate health implications for women.

Weaknesses
 The proposed research must be viewed in the overall context of obesity in women of childbearing age. The proposed study will address only a relatively minor component of the overall problem.

Investigators: Strengths
 The investigative team is outstanding with appropriate expertise for the proposed project. Weaknesses  None

Innovation: Strengths
 The use of social media has some innovative aspects.

Weaknesses
 Overall, the project does not present particularly novel approaches.

Approach:
Strengths  There are numerous strengths to the proposed approach. The applicants have already completed a single arm pilot study.  The applicants have clearly outlined the elements needed to design and conduct the subsequent trial.

Weaknesses
 The elements needed to design and execute the cost-effectiveness aspect of the study are not well developed.
1 R34 HL136979-01 4 ZHL1 CSR-G (F1) WARING, M  More detail regarding how the proposed trial will inform the sample size for a non-inferiority study would be useful.

Environment: Strength
 The environment for the proposed investigation appears to be outstanding.

Weaknesses
 None noted

CRITIQUE 2:
Significance: 3 Investigator(s): 2 Innovation: 3 Approach: 5 Environment: 2 Overall Impact: The investigators propose a pilot clinical trial to inform a subsequent non-inferiority trial comparing effectiveness and cost of a Facebook focused approach and an in-person visit approach to postpartum weight loss. The investigators will use a user-centered approach to inform the intervention refinement. However, a more detailed description of the intervention refinement process is needed to enhance the scientific rigor. Additionally, the pilot clinical trial has several methodological flaws. Of these methodological flaws, the potential of contamination, the assignment of counselors to both experimental conditions, selection bias, and several uncontrolled sources of measurement error draw concerns.

Significance: Strengths
 The retention of postpartum weight can contribute to obesity and increased cardiometabolic risk among women.  Traditional weight management programs are delivered in person. However, postpartum mothers are unlikely to attend in-person weight management programs consistently due to caregiving and other demands.  This proposed clinical trial will attempt to use a social media platform that is widely accepted and actively used among postpartum mothers for social support.

Weaknesses
 The investigators admit that it is unlikely that a Facebook delivered intervention will have superior benefits to traditional weight management programs.  It is unclear how the current proposed clinical trial or the subsequent confirmatory trial will advance this area of behavior change science. For instance, women can already access weight management programs online with formal and peer supports.

Investigator(s):
Strengths  The PI, Dr. Waring, is an epidemiologist and assistant professor. She qualifies as a NIH New and Early Stage Investigator. She has experience with conducting pilot clinical trials in weight management and delivering interventions through social media platforms.  This is a relatively established team of investigators. In particular, Drs. Simas-Moore, and Pagoto have a record of publication with Dr. Waring.  Dr. Wang (consultant), assistant professor of economics, states that his contribution to the project is to monitor cost-related data collection and conduct cost-related data analyses. Weaknesses 1 R34 HL136979-01 5 ZHL1 CSR-G (F1) WARING, M  The statistician on this project has relatively few publications and no recent funding.

Innovation: Strengths
 The investigators aim to leverage the usage of an online social media platform, Facebook, to deliver a postpartum weight-loss intervention.  If there are promising results from the proposed trial and larger confirmatory trial, there intervention has the potential for large population scalability.

Weaknesses
 Despite the adaption of an established Diabetes Prevention Program for postpartum women to attenuate weight gain and cardiometabolic risk, this proposed project does little to advance behavioral science focused on weight-loss.  Although Facebook is a widely used social media platform, the investigators do not fully address the issue of capturing the 'dose' of their intervention or the participant's time spent viewing study specific Facebook posts. Instead of directly addressing the issue, the investigators aim to use a combination of self-report measurements and general measures of Facebook use to describe the 'dose' or exposure to the Facebook experimental condition. Thus, if the investigators could have directly overcome the issue of capturing the dose or time exposed to Facebook condition resources, then this study would provide a methodological innovation that could advance eHealth intervention research using social media platforms.

Approach: Strengths
 The investigators provide sufficient justification of how the current R34 application will inform a subsequent clinical trial.  A user-centered approach is specified to assist with the refinement of the intervention, which may offer some insights on how to enhance engagement among participants randomly assigned to the Facebook experimental condition.  Although not explicitly stated, this project is designed as an unblinded two-arm randomized controlled trial and participants will be randomized using a permutated block design to controlled for variance in the numbers of postpartum days by participant.  Statistical analysis plan is consistent with the specific aims and well-explained.

Weaknesses
 There are several methodological concerns that affect the scientific rigor of the proposed clinical trial. For instance, in specific aim 1, there is reported that cost-related data will be analyzed but there is no mention of what cost-data related data will be captured or even what specific analytic techniques will be performed.  A lack of scientific rigor regarding the conduct the focus group(s). In particular, research strategy does not clearly outline the procedures for the analysis of the qualitative data, validation of the trustworthiness of these qualitative data, or provide a detailed description of the process that would be used among the investigators to inform their decision making. There is no justification for the sample size (N = 10) proposed for the intervention refinement focus groups.  Similarly, there is no justification for the sample size of 72 participants for the pilot clinical trial.  The investigators provide a sufficient review of the extant literature. Yet, the scientific premise of the intervention condition, its components and specification of dosage is not clearly articulated and mechanisms of how the interventions are expected to influence weight-loss are simply not presented.  Given the incidence of postpartum depressive symptoms that may alter health promotion behaviors, the investigators fail to address the phenomenon. There is no discussion of the incidence of postpartum depressive symptoms and the potential confounding effects on weight loss or physical activity.
1 R34 HL136979-01 6 ZHL1 CSR-G (F1) WARING, M  It is unclear how the investigators will account for social determinants of health (e.g., race/ethnicity, insurance, employment status, education, broadband/wireless access, financial resources, household demands, and financial strain) will impact the feasibility of the project or representativeness of the qualitative results for the intervention refinement process. Analysis of subgroups would be insightful and relevant to specific aim 1.  The investigators state that there is no difference in the content of the experimental condition.
Yet, plan to use counselors to administer resources across study conditions. A stronger design would be to isolate counselors to an experimental condition to minimize a threat to the internal validity of this study.  Given the threat of contamination, it is unclear why the investigator chose 6-months to evaluate if participants were exposed to other weight-loss programs.  It is unclear what the investigators will do if engagement in either experimental condition is low.
There are no benchmarks noted or procedures outlined on how to sustain engagement in either condition.  The investigators provide no rationale for the selection of instruments or procedures to reduce measurement error of the exploratory outcome of weight and other variables (e.g., Facebook time, physical activity monitoring, dose exposure in the Facebook condition).  Given the importance of the counselor, there is insufficient description of the counselor's background (e.g., dietician, nurse, or paraprofessional), which can affect the delivery of the counseling on perceived emotional support and subject engagement. Additional information is needed about who this person is and time related costs.

Environment: Strengths
 The investigative team has access to potential participants and the resources need to successful conduct this clinical trial.  Based on the data provided, the investigators should have access to sufficient numbers of potential participants.

Weaknesses
 It is unclear what the demographic characteristics of women who receive care at the study site or the Worcester community. This may pose a significant threat to the external generalizability of the study.

CRITIQUE 3:
Significance: 2 Investigator(s): 1 Innovation: 1 Approach: 3 Environment: 1 Overall Impact: The aim of this interesting study is to pilot test a Facebook based version of the Diabetes Prevention Program (DPP) modified to address post-partum weight loss. This is a significant project as a substantial proportion of women gain weight during pregnancy and either fail to lose this weight or continue to gain weight in the early parenting years. Mothers' weight status influences children's obesity and mother's health. Developing effective, easy-to-disseminate interventions to promote weight loss among new mothers has tremendous public health significance. Facebook is a social media platform used by a very high proportion of new parents, and could permits wide dissemination of the intervention should it prove successful. The intervention may be particularly useful for meeting the needs of busy and potentially overwhelmed new mothers. The PI has developed much of the protocol which is based on the DPP. The content of the intervention includes self-monitoring, 1 R34 HL136979-01 7 ZHL1 CSR-G (F1) WARING, M psychoeducation, links to resources to facilitate health promotion, use of activity trackers, and social support from group leaders and members of a private group created for participants on Facebook. The effects of the Face-book version of the intervention is compared to a face-to-face version of the same intervention delivered in a group format. Group formats have been demonstrated to support weight loss, the internet and Facebook are good sources of information and feedback.
A total of 10 participants will engage in focus group feedback discussions to facilitate modification of the program, and 72 participants will be assigned at random to either the Facebook or face to face interventions. Outcomes include measures of recruitment, feasibility, usage, and satisfaction, among other measures. Between-groups differences in weight loss will be assessed in an exploratory analysis. The PI is very strong and the investigative team has the expertise to engage in this project. They have biostatistics expertise, mHealth expertise, and health behavior change expertise, among other skills. They have been productive. A previous pilot study provided an opportunity to develop the protocols, but did not provide sufficient information to develop a full-fledged R01. The current study is necessary and generally would be sufficient to develop the R01. There is a good strategy for analyses and data management, and the PI has been very clear about the ways the information to be gathered in this trial will help develop the R01.
The primary concern is the lack of a plan for evaluating differential response to the two treatments. Some women may do better with FB interventions, others with in-person interventions. A pilot study cannot determine which interventions will be better for which women, but it can serve to identify possible theoretically or empirically-driven predictors. These predictors would enrich the value of the subsequent R01. The investigators have included some important variables that might predict differential response including social norms for weight loss and social support. But it would have been helpful to understand why they included these measures, and if they expect that availability of support predicts outcomes in response to one or the other interventions. Other variables may also be important predictors. For example, depression may serve as a barrier to the in person intervention but not the FB version. High levels of interpersonal sensitivity may serve as a barrier to the in person intervention but not the FB version. Distance from the clinic may also serve as a barrier to some types of participation, although ease of access and other neighborhood characteristics are not collected.
The investigators see contamination as a problem; however, obtaining weight loss support elsewhere could also be viewed as an index of patient activation and a positive sign.
There is very little information provided about the group leader or the interventions. No information is provided on the leaders qualifications or training. No information is provided on fidelity checks of intervention. This is critical since the leader will be conducting both types of interventions and may have opinions about which is better.

Significance: Strengths
 Highly significant project as postpartum weight loss is difficult, and chronic obesity has long term health implications for the mother and her family.  Facebook is a widely used social media platform, and research investigating its use as a public health tool is highly significant.  This project is necessary to develop an R01. If this R01 demonstrates that a Facebook version of the Diabetes Prevention Program is an effective tool for weight loss in the postpartum period, it could change the nature of intervention delivery for new mothers. The FB version could be widely disseminated, permitting distance treatment.

Weaknesses
 There are limitations to the ability to detect predictors of differential response to the FB vs faceto face intervention.