Weight Loss Interventions for Obesity

(PROMISE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether people with obesity lose more weight with assistance from a peer coach compared to self-guided efforts. One group will receive support from a peer coach through group sessions and phone calls, while the other group will use self-guided materials such as DVDs and online videos. Individuals with obesity (BMI 30-50) who regularly visit a doctor at one of the study's clinics may qualify for this trial. As an unphased study, this trial provides a unique opportunity to explore new weight loss strategies with peer 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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that peer coaching for weight loss is safe. Studies have found it helps people lose weight in a doctor's office setting without reported safety issues or negative effects, indicating the method is generally well-tolerated.

For the self-directed weight loss approach, evidence also supports its safety. Current studies indicate that people can successfully lose weight independently using written and video materials for guidance, suggesting the self-directed method is safe and manageable for most people.

Both methods focus on changing behaviors, such as diet and exercise, which are generally safe. Studies have not highlighted any major safety concerns for either approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these weight loss interventions because they offer a fresh approach to tackling obesity. Unlike traditional methods that often rely solely on self-guided programs or clinical-based treatments, one intervention uses peer coaching. This combines group sessions with personalized phone support, providing a unique blend of community and individual attention. The self-directed method, while similar to current options, empowers participants to pace themselves using structured, accessible materials like DVDs and online videos. These interventions aim to deliver flexibility and support in a way that could enhance motivation and adherence, potentially leading to more effective weight management.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that weight loss programs with peer coaches can help people lose weight. One study found that participants with peer coaches lost significant weight after 18 months. Another study demonstrated that having a peer coach led to reductions in weight, body mass index (BMI), and waist size. In this trial, participants in the peer coach treatment arm will receive support from a peer coach, potentially enhancing effectiveness compared to the self-directed treatment arm. In contrast, self-directed programs rely on individuals working independently, which can lead to different results without the support of a coach. ^{1 5 6 7 8}

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

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2838318

Peer Coaching to Support Weight Management in Primary ... Secondary clinical outcomes included mean (SE) weight change in percentage, proportion of patients achieving 5% or higher weight loss, and waist ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6133734/

A Weight Loss Intervention Delivered by Peer Coaches in ... This effectiveness trial compares 18-month outcomes between two conditions: 1) an intensive, behavioral weight loss intervention delivered by peer coaches (i.e. ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965182/

Peer Intervention in Obesity and Physical Activity Overall, peer interventions resulted in significant reduction in weight (28 studies), BMI (25 studies), waist circumference (12 studies) and a ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714418302258

A weight loss intervention delivered by peer coaches in ... A review reported effects ranging from 0.1 to 2.3 kg of weight loss with physician obesity counseling [17]. Programs including treatment delivered by non- ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e095883

Effectiveness and sustainability of peer support ... Previous research examining the effectiveness of peer support interventions for individuals who are overweight or obese has produced inconsistent and sometimes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12406063/

Peer Coaching to Support Weight Management in Primary ... The findings suggest that peer coaching can produce weight loss in primary care and promote enrollment in a weight management program. Abstract.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10482795/

The Effectiveness of eHealth Interventions for Weight Loss ... The review indicates that eHealth interventions are more effective than control interventions or no care and comparable to face-to-face interventions.

8. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.