Digital Health Weight Management Among Public Housing Residents

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Change, Body Obesity	Behavioral: mHealth Behavioral: CHW support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

515 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 28, 2021

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: mHealth Group

12 month text messaging program about diet and physical activity behavioral goals

Behavioral: mHealth

Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.

Experimental: mHealth+Community Health Worker (CHW) support

same as mHealth group + monthly behavioral phone counseling by a CHW

Behavioral: mHealth

Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.

Behavioral: CHW support

The CHW will provide behavioral counseling to participants guided by a study website related to their healthy eating and physical activity goals.

No Intervention: Control group

Assessments only

Outcome Measures

Primary Outcome Measures

Change in Weight at 12-month follow up [Baseline, 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.

Secondary Outcome Measures

Change in Weight at 6-month follow up [Baseline, 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.
Diet behavior [Baseline, 6-month follow up, 12-month follow up]
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.
Physical activity behavior [Baseline, 6-month follow up, 12-month follow up]
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.
Psycho-social variables [Baseline, 6-month follow up, 12-month follow up]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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