NCT04852042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

September 28, 2021

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

April 16, 2021

Last Update Submit

September 22, 2025

Conditions

Keywords

Community health workersPublic housing residentsBehavioral interventionsHealthy eatingPhysical activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Weight at 6-month follow up

    Baseline, 6-month follow up

  • Diet behavior

    Baseline, 6-month follow up, 12-month follow up

  • Physical activity behavior

    Baseline, 6-month follow up, 12-month follow up

  • Psycho-social variables

    Baseline, 6-month follow up, 12-month follow up

Study Arms (3)

mHealth Group

EXPERIMENTAL

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

Behavioral: mHealth

mHealth+Community Health Worker (CHW) support

EXPERIMENTAL

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

Behavioral: mHealthBehavioral: CHW support

Control group

NO INTERVENTION

Assessments only

Interventions

mHealthBEHAVIORAL

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

mHealth GroupmHealth+Community Health Worker (CHW) support
CHW supportBEHAVIORAL

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

mHealth+Community Health Worker (CHW) support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Body Weight ChangesObesityMotor Activity

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Lisa Quintiliani, PhD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR
  • Ziming Xuan, ScD

    BU School of Public Health, Community Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

September 28, 2021

Primary Completion

August 7, 2025

Study Completion

August 11, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations