Digital Health Weight Management Among Public Housing Residents

Digital Health Supported Weight Management Intervention Delivered by Community Health Workers 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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Change, Body
• Intervention / Treatment: Behavioral: mHealth; Behavioral: CHW support

• Study Type: Interventional
• Enrollment (Estimated): 348
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziming Xuan, ScD; Phone Number: 617-638-4118; Email: zxuan@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Ziming Xuan, ScD; Phone Number: 617-638-4118; Email: zxuan@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Lisa Quintiliani, PhD, Tufts Medical Center; Principal Investigator: Ziming Xuan, ScD, BU School of Public Health, Community Health Services

Publications and helpful links

General Publications

• Solar C, Nansubuga A, Murillo J, Ranker L, Borrelli B, Bowen DJ, Xuan Z, Kane J, Werntz S, Crouter SE, Quintiliani LM. Mobile health plus community health worker support for weight management among public housing residents (Path to Health): A randomized controlled trial protocol. Contemp Clin Trials. 2022 Aug;119:106836. doi: 10.1016/j.cct.2022.106836. Epub 2022 Jun 18.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Physical activity; Community health workers; Healthy eating; Behavioral interventions; Public housing residents
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes
• Other Study ID Numbers: H-41590; 1R01CA238335-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No