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Digital Health Weight Management for Obesity
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-month follow up, 12-month follow up
Awards & highlights
Study 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.
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 belowSelect...
I can read and speak English or Spanish.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6-month follow up, 12-month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-month follow up, 12-month follow up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Weight at 12-month follow up
Secondary outcome measures
Change in Weight at 6-month follow up
Diet behavior
Physical activity behavior
+1 moreTrial 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
~1660
Find a Location
Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
258 Previous Clinical Trials
263,889 Total Patients Enrolled
6 Trials studying Obesity
4,686 Patients Enrolled for Obesity
Boston Medical CenterLead Sponsor
388 Previous Clinical Trials
873,652 Total Patients Enrolled
15 Trials studying Obesity
67,076 Patients Enrolled for Obesity
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,098 Total Patients Enrolled
104 Trials studying Obesity
25,800 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I get short of breath with very low activity despite using aids.I am willing to wear a physical activity tracker.I frequently experience heart or chest pain.My blood pressure often exceeds 175/110.I have a physical condition that prevents me from exercising.I have been diagnosed with a mental health condition like bipolar disorder or schizophrenia and am not taking medication for it.You are not currently considering making changes to your diet or exercise habits to improve your health.I have health issues that prevent me from exercising.I can read and speak English or Spanish.I had a heart attack within the last 6 months.My doctor has advised me not to exercise due to a bone or joint problem.I need a wheelchair, scooter, walker, or extra oxygen to move around.I need help to walk.I am not in a weight loss program or study that conflicts with this trial.I often feel faint or have severe dizziness.
Research Study Groups:
This trial has the following groups:- Group 1: mHealth Group
- Group 2: mHealth+Community Health Worker (CHW) support
- Group 3: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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