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Digital Health Weight Management for Obesity

Boston, MA
N/A
Waitlist Available
Led By Lisa Quintiliani, PhD
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to read and speak in English or Spanish
Be older than 18 years old
Must not have
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
Has very high blood pressure that is often over 175 or the bottom blood pressure number is often over 110
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-month follow up, 12-month follow up
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a weight management intervention consisting of text messages and monthly phone counseling will be more effective in promoting weight loss than text messages alone or no intervention.

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Who is the study for?
This trial is for Boston public housing residents who are not in a weight loss program, don't have certain mental health conditions untreated by medication, aren't pregnant, and have no medical issues preventing exercise. Participants must be able to text and wear an activity tracker.Check my eligibility
What is being tested?
The study tests a weight management intervention comparing three groups: one using mobile health (mHealth) tech, another adding Community Health Worker support to mHealth, and a control group. It aims to see if the combined approach is more effective.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication, side effects may include typical reactions to increased physical activity or dietary adjustments such as muscle soreness or digestive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can read and speak English or Spanish.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I get short of breath with very low activity despite using aids.
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My blood pressure often exceeds 175/110.
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I have been diagnosed with a mental health condition like bipolar disorder or schizophrenia and am not taking medication for it.
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I have health issues that prevent me from exercising.
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I had a heart attack within the last 6 months.
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I need a wheelchair, scooter, walker, or extra oxygen to move around.
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I need help to walk.
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I am not in a weight loss program or study that conflicts with this trial.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-month follow up, 12-month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6-month follow up, 12-month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Weight at 12-month follow up
Secondary study objectives
Change in Weight at 6-month follow up
Diet behavior
Physical activity behavior
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: mHealth+Community Health Worker (CHW) supportExperimental Treatment2 Interventions
same as mHealth group + monthly behavioral phone counseling by a CHW
Group II: mHealth GroupExperimental Treatment1 Intervention
12 month text messaging program about diet and physical activity behavioral goals
Group III: Control groupActive Control1 Intervention
Assessments only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mHealth
2014
Completed Phase 3
~1960

Find a Location

Closest Location:Boston Medical Center· Boston, MA

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
263,795 Total Patients Enrolled
6 Trials studying Obesity
4,585 Patients Enrolled for Obesity
Boston Medical CenterLead Sponsor
409 Previous Clinical Trials
889,543 Total Patients Enrolled
15 Trials studying Obesity
67,076 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,893 Previous Clinical Trials
8,051,685 Total Patients Enrolled
109 Trials studying Obesity
26,757 Patients Enrolled for Obesity
National Cancer Institute (NCI)NIH
14,068 Previous Clinical Trials
41,159,783 Total Patients Enrolled
53 Trials studying Obesity
32,328 Patients Enrolled for Obesity
Lisa Quintiliani, PhDPrincipal InvestigatorTufts Medical Center
2 Previous Clinical Trials
449 Total Patients Enrolled
Ziming Xuan, ScDPrincipal InvestigatorBU School of Public Health, Community Health Services

Media Library

CHW support Clinical Trial Eligibility Overview. Trial Name: NCT04852042 — N/A
Obesity Research Study Groups: mHealth Group, mHealth+Community Health Worker (CHW) support, Control group
Obesity Clinical Trial 2023: CHW support Highlights & Side Effects. Trial Name: NCT04852042 — N/A
CHW support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04852042 — N/A
~30 spots leftby Jul 2025
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