Weight Loss Interventions for Obesity

(PROMISE Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Antipsychotics, MAOIs, Corticosteroids, Chemotherapy

Disqualifiers: Uncontrolled hypertension, Recent MI, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

375 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, chemotherapeutic drugs, and prescription weight loss medications used in the past six months.

Is the weight loss intervention using peer coaches safe for humans?

The studies on weight loss interventions using peer coaches do not report any safety concerns, suggesting that this approach is generally safe for humans. ^{1 2 3 4 5}

How does the peer coach weight loss treatment differ from other obesity treatments?

The peer coach weight loss treatment is unique because it involves ongoing support from trained community health workers who provide personalized guidance through in-person visits and phone calls, making it more accessible and potentially more effective than self-directed or traditional primary care interventions. ^{1 2 3 4 5}

What data supports the effectiveness of the weight loss intervention - peer coach and self-directed treatment for obesity?

Research shows that peer coaching can be a feasible and effective way to help people lose weight, as seen in studies where participants reported weight loss and high satisfaction with the program. For example, in a study with ethnic minority women, those who received peer coaching lost weight, while those who did not gained weight. ^{1 2 4 5 6}

Who Is on the Research Team?

Gareth Dutton, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Receiving primary care services at one of the practices participating in this study

I am between 21 and 75 years old.

Body mass index (BMI) 30-50 kg/m2

Exclusion Criteria

I have a history of severe heart failure.

I am willing and able to give informed consent, understand English, accept random assignment, and travel to the intervention site.

Uncontrolled hypertension (blood pressure >160/100 mm Hg at screening)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a primary care weight management intervention delivered by peer coaches or a self-directed program

18 months

In-person group sessions and individual telephone contacts for peer coach group; self-paced for self-directed group

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• weight loss intervention - peer coach
• weight loss intervention - self directed

Trial Overview 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.

How Is the Trial Designed?

Group I: Peer coach treatment Experimental Treatment 1 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 treatment Active Control 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

This trial will assess the effectiveness of a weight loss intervention involving peer coaches over 18 months, with 375 adults with obesity participating from 10 primary care practices, aiming to improve body weight and patient-centered outcomes.

If successful, the peer coach model could provide a sustainable and practical approach to weight management in primary care, potentially enhancing clinical outcomes and reducing healthcare costs related to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A weight loss intervention delivered by peer coaches in primary care: Rationale and study design of the PROMISE trial. Dutton, GR., Lewis, CE., Cherrington, A., et al.[2023]

A pilot study involving 10 individuals with serious mental illness (SMI) tested a peer health coaching model for weight management over 6 months, showing that 56% of participants lost weight, with an average loss of 2.7 kg.

Participants expressed high satisfaction with the program, indicating that peer health coaching is a feasible approach for addressing obesity in individuals with SMI, although further research is needed to assess its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer health coaching for overweight and obese individuals with serious mental illness: intervention development and initial feasibility study. Aschbrenner, KA., Naslund, JA., Barre, LK., et al.[2022]

In a pilot study involving 33 predominantly African American participants with obesity and diabetes or prediabetes, a weight loss intervention combining group visits and peer coaching led to a significant average weight loss of 4.5 kg, with 27% of participants losing at least 5% of their initial body weight.

Participants found the program acceptable, completing about 50% of group visits and 40% of peer coaching calls, indicating that this novel approach to weight management in primary care is feasible and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study evaluating the feasibility and initial outcomes of a primary care weight loss intervention with peer coaches. Dutton, GR., Phillips, JM., Kukkamalla, M., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

A weight loss intervention delivered by peer coaches in primary care: Rationale and study design of the PROMISE trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of using a peer coach to deliver a behavioral intervention for promoting postpartum weight loss in Black and Latina mothers. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Peer health coaching for overweight and obese individuals with serious mental illness: intervention development and initial feasibility study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pilot study evaluating the feasibility and initial outcomes of a primary care weight loss intervention with peer coaches. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of utilising an all-volunteer workforce as a disruptive innovation for the US obesity epidemic. [2021]