Digital Health Weight Management Among Public Housing Residents

Study Overview
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Brief Summary
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This research will test the efficacy of a weight management intervention through a three-group randomized trial: mHealth only, mHealth+Community Health Worker (CHW) support, versus control group, among residents of Boston's public housing developments. The mHealth group consists of a 1-year text messaging program to promote diet and physical activity behavior changes and the CHW support consists of monthly phone counseling delivered by a CHW to support the text messaging program. Our hypothesis is that the mHealth+CHW group will be more effective in bringing about weight loss compared to mHealth alone or the assessment only control group. The findings are expected to inform future health promotion efforts among residents in public housing developments.

Official Title
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Digital Health Supported Weight Management Intervention Delivered by Community Health Workers Among Public Housing Residents

Conditions
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Weight Change, Body, Obesity

Intervention / Treatment
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* Behavioral: mHealth
* Behavioral: CHW support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current resident of Boston public housing development No plans to move within the next 6 months and no plan on leaving the country for more than 2 months over the next year Able to read and speak in English or Spanish Has cell phone with a plan that allows for unlimited text messages Willing to wear a device to track physical activity during assessment periods Exclusion Criteria: Currently enrolled in a comprehensive weight loss program or a research study about weight that is incompatible with study participation Currently on a medically prescribed diet or fast that is incompatible with study participation Currently has a diagnosis of bipolar disorder, mania, manic-depressive disorder, schizophrenia, or psychosis and is not on any medications to treat the condition Precontemplation stage of change for making healthy eating or physical activity changes Pregnancy Medical contraindications to physical activity. Self-reported presence of any of the following: Can not walk without help from someone else Regularly needs to use the following special equipment to walk or get around: wheelchair, scooter, walker, or extra oxygen Gets short of breath even when using special equipment at a very low level of physical activity such as walking around the home, making a bed, or taking a bath Advised by a healthcare professional not to exercise and or if diagnosed with a bone or joint problem, it could get worse. Frequently gets pains in the heart or chest Had a heart attack in the past 6 months Often feels faint or has spells of severe dizziness Has very high blood pressure that is often over 175 or the bottom blood pressure number is often over 110 Has a good physical reason not to follow an activity program even if they wanted to

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mHealth Group<br>12 month text messaging program about diet and physical activity behavioral goals | Behavioral: mHealth<br>* Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.<br>|
| Experimental: mHealth+Community Health Worker (CHW) support<br>same as mHealth group + monthly behavioral phone counseling by a CHW | Behavioral: mHealth<br>* Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.<br>Behavioral: CHW support<br>* The CHW will provide behavioral counseling to participants guided by a study website related to their healthy eating and physical activity goals.<br>|
| No Intervention: Control group<br>Assessments only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight at 12-month follow up | Weight will be objectively measured by study staff using standard procedures using an accurate electronic scale designed for portable use measured to the nearest 1/10th reading. | Baseline, 12-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight at 6-month follow up | Weight will be objectively measured by study staff using standard procedures using an accurate electronic scale designed for portable use measured to the nearest 1/10th reading. | Baseline, 6-month follow up | 
| Diet behavior | Diet (for example: fruits & vegetables, whole grains, lean meats, and sugary beverages) will be measured via unannounced 24-hour recalls, one per person per assessment period. Other diet behaviors (for example: breakfast consumption) will be measured via questions on standardized surveys. | Baseline, 6-month follow up, 12-month follow up | 
| Physical activity behavior | Physical activity will be objectively measured via Actigraph 3tx accelerometers worn by participants for 7 days (minimum of 4 days) to assess time spent in light-to-moderate-to-vigorous physical activity. | Baseline, 6-month follow up, 12-month follow up | 
| Psycho-social variables | Psycho-social variables (for example: Self-efficacy, motivation, outcome expectations, depressive symptoms, sleep, social support) will be evaluated for change over the intervention period and whether they moderate the intervention effect on weight. | Baseline, 6-month follow up, 12-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community health workers, Public housing residents, Behavioral interventions, Healthy eating, Physical activity