A Tailored Web- and Text-Based Intervention to Increase Physical Activity for Latino Men: Protocol for a Randomized Controlled Feasibility Trial

Background Latino men in the United States report low physical activity (PA) levels and related health conditions (eg, diabetes and obesity). Engaging in regular PA can reduce the risk of chronic diseases and yield many health benefits; however, there is a paucity of interventions developed exclusively for Latino men. Objective To address the need for culturally relevant PA interventions, this study aims to develop and evaluate Hombres Saludables, a 6-month theory-based, tailored web- and text message-based PA intervention in Spanish for Latino men. This protocol paper describes the study design, intervention, and evaluation methods for Hombres Saludables. Methods Latino men aged 18-65 years were randomized to either the individually tailored PA internet intervention arm or the nutrition and wellness internet control arm. The PA intervention included 2 check-in phone calls; automated SMS text messages; a pedometer; a 6-month gym membership; access to a private Facebook group; and an interactive website with PA tracking, goal setting, and individually tailored PA content. The primary outcomes were feasibility, acceptability, and efficacy (minutes per week of total moderate-to-vigorous PA assessed via the ActiGraph GT3X+ accelerometer worn at the waist and 7-day physical activity recall at baseline and 6 months). Secondary outcomes examined potential moderators (eg, demographics, acculturation, and environmental variables) and mediators (eg, self-efficacy and cognitive and behavioral processes of change) of treatment effects at 6 months post randomization. Results This study was funded in September 2016. Initial institutional review board approval was received in February 2017, and focus groups and intervention development were conducted from April 2017 to January 2018. Recruitment for the clinical trial was carried out from February 2018 to July 2019. Baseline data collection was carried out from February 2018 to October 2019, with a total of 43 participants randomized. Follow-up data were collected through April 2020. Data cleaning and analysis are ongoing. Conclusions We developed and tested protocols for a highly accessible, culturally and linguistically relevant, theory-driven PA intervention for Latino men. Hombres Saludables used an innovative, interactive, web- and text message–based intervention for improving PA among Latino men, an underserved population at risk of low PA and related chronic disease. If the intervention demonstrates feasibility, acceptability, and preliminary efficacy, we will refine and evaluate it in a larger randomized control trial. Trial Registration Clinicaltrials.gov: NCT03196570; https://clinicaltrials.gov/ct2/show/NCT03196570 International Registered Report Identifier (IRRID) DERR1-10.2196/23690


R34 HL128067-01A1
3 CLTR (MA) GANS, K PUBLIC HEALTH RELEVANCE: Latino men report particularly low rates of physical activity (PA) and are disproportionately burdened by health conditions related to sedentary lifestyle. The proposed research will build on a series of previous successful studies to develop an individually tailored intervention using a combination of web and texting that is culturally and linguistically appropriate for a diverse population of Latino men and addresses their PA barriers and preferences. We will conduct focus groups with a diverse population of Latino men to ensure that the intervention is culturally appropriate for Latino men of Caribbean, South and Central American origin and to adapt/develop the new intervention components. Then we will evaluate the intervention's feasibility, acceptability, and preliminary efficacy in a pilot study with 50 diverse Latino men.

CRITIQUE 1:
Significance: 1 Investigator(s): 1 Innovation: 2 Approach: 1 Environment: 1 Overall Impact: The aim of the revised study is to develop a physical activity (PA) intervention tailored to the needs of Latino men and which could be potentially scalable if effective. The PI has been very responsive to the critiques and the program of research is substantially improved. In particular, with some changes to the methodology, the application now is able to ask a theoretically and methodologically important question: How does the physical environment, including access to recreational activities, affect the outcome of individual-level interventions focused primarily on increasing motivation and shaping selfregulatory skills. The person X environment interactions which can now be investigated will yield information which could be of value for a wide range of lifestyle interventions. The research team is excellent; they have a history of successful work with both PA interventions and with this population. The intervention itself is based on a program that has been successfully used with Latina women which they have modified in some initial testing to meet the needs of men. The intervention emerges from a solid theoretical foundation; with intervention components based on Social Cognitive theory and transtheoretical models. Even the content of the text messaging is based on empirically validated behavior change principles related to normative and aspirational messaging, problems solving, etc. The control condition (NIH materials on health) is now appropriate. Portions of the intervention will now be delivered via the web. Good information is provided on the potential R01 which would follow this study.

Significance: Strengths
 Low levels of PA are a significant risk factor for a wide variety of chronic illness. Low PA is a specific problem for Latino men.  There have been very few targeted interventions for Latino men, and developing these interventions is a recognized need.  Self-managed PA intervention is relatively low cost and scalable and could create population level differences in health outcomes.  Estimating the ways in which neighborhood factors influence outcomes could provide additional needed insight into environmental barriers to PA. This information could help identify resources needed to facilitate self-management. This intervention, like most current lifestyle interventions is focused on improving individual-level motivation and self-regulatory skills. However, very little is known about the degree to which barriers in the social and physical environment influence the effectiveness of individual-level motivational/skills building interventions. This study now has a much more detailed evaluation of the barriers and of the physical environment. This will allow the investigators to understand the degree to which these barriers (e.g. distance from parkland 1 R34 HL128067-01A1 4 CLTR (MA) GANS, K or other recreational facilities, etc.) are surmountable by individual-level interventions to improve motivation and skills. Weaknesses  It would have been stronger if the PI were able to use a stratified sampling method, such that half the intervention and control participants could come from neighborhoods with high versus low physical resources. However, this may not be feasible and could be a goal for a future study.
 It is unclear if the PI anticipates including Mexican-American men. If so, how will group (i.e., Mexican vs. Columbian vs. Puerto Rican, etc.) differences in the drivers of PA be accounted for in the conceptualization of the study and analyses of the outcomes.

Investigator(s): Strengths
 This is a very strong research team with good experience in community based research. This is difficult research to do, and the researchers are clearly very experienced in working with this population. Good coordination plans. Weaknesses  None noted.

Innovation: Strengths
 The detailed assessment of barriers, both personal and environmental, substantially improves the innovation of this application. The target population is innovative. The content of the text messaging is innovative -a theory-based improvement on the usual reminders to complete the activity. The use of the web to target interventions for Latino men is still moderately innovative. Weaknesses  Self-managed PA interventions are not innovative at this point.

Approach: Strengths
 Good recruitment strategies.  Good measures of PA, health literacy, acculturation. Thorough, well documented.  Good procedures for screening, pre-test assessments, follow-up.  Good application of empirically validated strategies to text messaging and intervention content.  Good retention procedures.  Reasonable analytic strategy.  Improved control condition.  Better measures of personal and environmental barriers.

Weaknesses
 None noted.

Environment: Strengths
 Strong environment with all needed resources.
Weaknesses  None noted.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections  Thoughtful plan. Overall Impact: This is a resubmission of a application to study the development and pilot study of an intervention to study web and text based interventions targeting increasing physical activity in Latino Men. This is a similar approach to other studies designed to study Latino women. There are 2 primary aims to 1) develop the intervention using 6 focus groups (8-10 men) which will provide substantive feedback on specific needs for this population; 2) Pilot a small trial in 50 Latino men primarily of Puerto Rican, Dominican and Colombian descent using the web/phone based intervention over 6 months. The participants will be seen at baseline and 6 months with monthly assessments by mail. Participants will receive text messages to increase physical activity. An accelerometer will be used to assess activity at baseline and 6 months which will be worn over 7 days. They will use a pedometer daily and track their activity which will be entered online. Several questionnaires will be administered throughout to assess behavioral change (decisional balance, cognitive/behavioral change process, and self-efficacy). In addition environmental factors will be assessed. Other data will be collected to qualify the overall results such as demographics, acculturation, consumer satisfaction, functional health literacy and 7 day physical activity tracking. The impact of this application is that it will provide the necessary information to conduct a larger more definitive trial in this population of Latino men. This type of targeted intervention has not been done for Latino men in the past in whom the risk of CVD, Diabetes and other disease which are clearly affected by physical inactivity. This is a mirror of studies done in Latino women and similar to a trial ongoing in Mexican men in San Diego.

Significance: Strengths
 The significance of the study is that it targets an at risk group who have not been studied in the past.  This project will advance the field of lifestyle modification for culturally specific groups.

Weaknesses
 None noted.

Investigator(s): Strengths
 The investigative team is well prepared to conduct this project.

INCLUSION OF MINORITIES PLAN (Resume): ACCEPTABLE
Only minorities -Latino men.

COMMITTEE BUDGET RECOMMENDATIONS: The budget was recommended as requested.
Footnotes for 1 R34 HL128067-01A1; PI Name: Gans, Kim M.
NIH has modified its policy regarding the receipt of resubmissions (amended applications). See Guide Notice NOT-OD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-074.html. The impact/priority score is calculated after discussion of an application by averaging the overall scores (1-9) given by all voting reviewers on the committee and multiplying by 10. The criterion scores are submitted prior to the meeting by the individual reviewers assigned to an application, and are not discussed specifically at the review meeting or calculated into the overall impact score. Some applications also receive a percentile ranking. For details on the review process, see http://grants.nih.gov/grants/peer_review_process.htm#scoring. Consultants are required to absent themselves from the room during the review of any application if their presence would constitute or appear to constitute a conflict of interest.