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Weight Loss Interventions for Obesity (PROMISE Trial)

N/A
Waitlist Available
Led By Gareth Dutton, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-75 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, and 18 months
Awards & highlights

PROMISE Trial Summary

This trial will test whether a weight-loss program with peer support is more effective than a self-directed program.

Who is the study for?
This trial is for adults aged 21-75 with obesity (BMI of 30-50) who are getting care at participating practices. It's not for those with uncontrolled high blood pressure, recent heart issues, certain severe diseases, or on specific medications like antipsychotics or weight loss drugs. People who can't consent, follow the study plan, or might move away soon can't join.Check my eligibility
What is being tested?
The study is testing if a weight management program in primary care guided by peer coaches helps people lose more weight compared to managing their own weight without such support. Participants will be randomly assigned to one of these two approaches.See study design
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medication, side effects may include typical reactions to diet changes and increased physical activity such as muscle soreness, fatigue, and possible nutritional deficiencies if not monitored properly.

PROMISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 75 years old.

PROMISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
body weight
Secondary outcome measures
healthcare utilization
mood
physical activity
+6 more

PROMISE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Peer coach treatmentExperimental Treatment1 Intervention
Participants randomly assigned to this arm will receive a combination of in-person, group-based behavioral weight loss sessions plus individual, telephone contacts. Groups and phone calls will be facilitated by a peer coach interventionist. Similar to the self-directed condition, participants will receive written and pre-recorded intervention materials (i.e., DVDs, online videos). They will also have continued contact with their physician for routine medical care.
Group II: Self-directed treatmentActive Control1 Intervention
Participants randomly assigned to this arm will receive written and pre-recorded behavioral weight loss intervention materials (i.e., DVDs, online videos), and they will be instructed to work through the materials independently at their own pace. They will have continued physician contact as needed for routine medical care.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,584 Previous Clinical Trials
2,279,698 Total Patients Enrolled
72 Trials studying Obesity
473,755 Patients Enrolled for Obesity
Gareth Dutton, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
286 Total Patients Enrolled
2 Trials studying Obesity
106 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the screening criteria to be a part of this research?

"To participate in this study, which is looking for a total of 375 patients, individuals must be 21 to 75 years old and have a body mass index (BMI) that classifies them as obese."

Answered by AI

Does the age limit for this program stop at 75 years old?

"The age limit for patients wishing to participate in this trial is 75 years old. Patients must also be of legal drinking age in their country or state."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
University of Alabama in Birmingham

Why did patients apply to this trial?

Weight loss I need to lose weight.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Partnership Optimizes Weight Management in Primary Care
Gareth R. Dutton PhD 2017. "Partnership Optimizes Weight Management in Primary Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02959021.
~45 spots leftby Apr 2025
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