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NCT Number: NCT04852042

Digital Health Weight Management Among Public Housing Residents

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.

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Key information

Conditions

Weight Change, Body Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth

Behavioral

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

CHW support

Behavioral

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

Primary outcomes

  1. Change in Weight at 12-month follow up

    Time frame: 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 outcomes

  1. Change in Weight at 6-month follow up

    Time frame: 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.

  2. Diet behavior

    Time frame: 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.

  3. Physical activity behavior

    Time frame: 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.

  4. Psycho-social variables

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2021
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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