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Weight Change, BodyNCT04852042

Digital Health Weight Management Among Public Housing Residents

A study testing mHealth and CHW support in people with Weight Change, Body and Obesity, run by Tufts Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Weight Change, Body, Obesity
What is being tested?
mHealth and CHW support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteUnited States
Study dates
28 Sep 2021to 11 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: 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.

Being tested
mHealth, CHW support
Keywords
Community health workers, Public housing residents, Behavioral interventions, Healthy eating, Physical activity
Medical subject headings
Body Weight Changes, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealthBehavioural

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

  • CHW supportBehavioural

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

Study groups in NCT04852042
Study groupRoleWhat they receive
mHealth GroupExperimental12 month text messaging program about diet and physical activity behavioral goals
Receives: Behavioral: mHealth
mHealth+Community Health Worker (CHW) supportExperimentalsame as mHealth group + monthly behavioral phone counseling by a CHW
Receives: Behavioral: mHealth; Behavioral: CHW support
Control groupNo interventionAssessments only

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 12-month follow up

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, 6-month follow up

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start28 Sep 2021
  3. Primary completion7 Aug 2025
  4. Study completion11 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04852042
Sponsor's protocol ID
H-41590
Other IDs
1R01CA238335-01A1
Status last verified
Sep 2025
First submitted
16 Apr 2021
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 35724842

Questions about this trial

What is this clinical trial studying?

A study testing mHealth and CHW support in people with Weight Change, Body and Obesity, run by Tufts Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight at 12-month follow up (time frame: Baseline, 12-month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04852042, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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