An interventional study of mHealth and CHW support in Weight Change, Body and Obesity, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Prevention
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.
231 studies on the registry are indexed under Body Weight Changes; 30 are open to participants now.
This study's enrollment of 316 is above the median of 80 across 179 interventional studies indexed under Body Weight Changes.
Browse Body Weight Changes studies →Tufts Medical Center is the lead sponsor of 200 studies on the registry; 28 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 16 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Medical to physical activity. Self-reported presence of any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 month text messaging program about diet and physical activity behavioral goals
Behavioral: mHealth
same as mHealth group + monthly behavioral phone counseling by a CHW
Behavioral: mHealth · Behavioral: CHW support
Assessments only
Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.
The CHW will provide behavioral counseling to participants guided by a study website related to their healthy eating and physical activity goals.
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.
Time frame: Baseline, 12-month follow up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6-month follow up, 12-month follow up
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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