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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

Must not have

History of NYHA Class III or IV congestive heart failure

History of type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6, 12, and 18 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of severe heart failure.

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I have been diagnosed with type 1 diabetes.

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I have lost more than 10 pounds in the last six months.

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I have had weight loss surgery in the past.

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I have a chronic lung disease that affects my daily activities.

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I have not had unstable chest pain in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6, 12, and 18 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

body weight

Secondary study objectives

healthcare utilization

mood

physical activity

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met