Digital Health Weight Management Among Public Housing Residents

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852042
• Other study ID #: H-41590
• Secondary ID: 1R01CA238335-01A
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Tufts Medical Center
• Contact: Ziming Xuan, ScD
• Phone: 617-638-4118
• Email: zxuan[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Obesity
• Weight Change, Body

Intervention

Behavioral:
• mHealth
Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.
• CHW support
The CHW will provide behavioral counseling to participants guided by a study website related to their healthy eating and physical activity goals.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Tufts Medical Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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