Weight Loss Maintenance for Obesity

(POWERS Trial)

Recruiting at 3 trial locations

Overseen By Michael Rosenbaum, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Anticoagulants, Antiretrovirals, Appetite suppressants, others

Disqualifiers: Diabetes, Cardiovascular disease, Cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some people with obesity regain weight after losing it through a behavioral weight loss program. Participants will join a program to lose at least 7% of their starting weight and then maintain that weight for a short period. Researchers will monitor them over a year to study their weight changes. Individuals who have maintained a stable weight for the past six months, have a BMI of 30 to less than 40, and have internet access might be a good fit.

As an unphased trial, this study offers a unique opportunity to contribute to understanding weight management challenges.

Will I have to stop taking my current medications?

The trial requires that you do not take medications or supplements that affect appetite, energy expenditure, or weight, such as appetite suppressants or certain steroids. If you are on such medications, you may need to stop them to participate.

What prior data suggests that this behavioral weight loss program is safe?

Research has shown that lifestyle programs like the one in this trial are generally safe for adults with obesity. These programs typically involve dietary changes and increased physical activity to aid weight loss. Studies have found that participants tolerate these programs well, with few reports of serious side effects.

For instance, one study reviewed evidence from lifestyle programs and found they effectively reduced body weight and body mass index (BMI) without significant negative effects. Another study demonstrated that short-term programs focusing on exercise and diet changes led to successful weight loss for adults, again noting minimal side effects.

Overall, lifestyle programs for weight loss have a good safety record, making them a reliable option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the weight loss treatment because it introduces a comprehensive 37-week behavioral intervention that focuses on both reducing energy intake and boosting physical activity. Unlike typical weight loss methods that might rely heavily on medications or surgical procedures, this approach empowers individuals to make sustainable lifestyle changes. The goal is to help people maintain their weight loss over time by building healthier habits rather than just aiming for short-term results. This method could provide a more holistic and enduring solution to obesity, which is why it’s generating interest.

What evidence suggests that this behavioral weight loss program is effective for obesity?

Research shows that weight loss programs focusing on healthy eating and exercise can help adults with obesity lose weight. Studies have found that people in these programs often lose 5% or more of their starting weight. This amount of weight loss can improve health and lower the risks associated with obesity. Evidence suggests that these programs can help people lose weight and maintain it over time. Participants in this trial will engage in a 37-week behavioral intervention aimed at decreasing energy intake and increasing physical activity. ^{1 3 4 6 7}

Who Is on the Research Team?

Steven Belle, PhD

Principal Investigator

University of Pittsburgh

Dympna Gallagher, EdD

Principal Investigator

Columbia University

Susan Roberts, PhD

Principal Investigator

Dartmouth College

Are You a Good Fit for This Trial?

Adults aged 25-59 with obesity (BMI: 30-<40 kg/m2) who've been stable in weight for the past 6 months, not pregnant or planning pregnancy within two years, without severe heart conditions, thyroid disease requiring medication, renal disease needing dialysis, liver issues, substance abuse problems, extreme dietary restrictions like veganism or very low carb/fat diets. Participants must have internet access and be able to do ergometry testing.

Inclusion Criteria

Within 5% of current weight, for the past 6 months

BMI: 30 - <40 kg/m2

I am between 25 and 59 years old.

Exclusion Criteria

Unwillingness to abstain from marijuana/cannabis use for 3 weeks at each of the four assessment time points

I am on dialysis for kidney failure.

I take medication for thyroid disease or my TSH levels are not normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo a baseline evaluation prior to starting the weight loss intervention

1 week

Behavioral Weight Loss Program

Participants engage in a behavioral intervention aimed at decreasing energy intake and increasing physical activity to achieve at least 7 percent weight loss

20 weeks

Weight Stabilization

Participants maintain weight stability for 2 weeks after achieving weight loss goal

2 weeks

Follow-up

Participants are monitored for weight change and undergo clinical examinations at 4 months and 12 months after weight stabilization

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weight loss

Trial Overview The study aims to understand why overweight individuals tend to regain weight after a behavioral weight loss program. It involves an initial evaluation followed by up to a 20-week program aiming for at least a 7% weight reduction from baseline within 37 weeks. Successful participants will then be monitored over one year with clinical exams at four and twelve months post-program.

How Is the Trial Designed?

Group I: Weight loss Experimental Treatment 1 Intervention

A 37 week behavioral intervention aimed at decreasing energy intake and increasing physical activity.

Weight loss is already approved in United States, European Union for the following indications:

Approved in United States as Behavioral Weight Loss Program for:

• Obesity
• Weight Management

Approved in European Union as Weight Management Program for:

• Obesity
• Overweight

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

New York State Psychiatric Institute

Collaborator

Trials

481

Recruited

154,000+

Tufts University

Collaborator

Trials

271

Recruited

595,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Participants who followed a 12-month clustered campaign treatment schedule regained significantly less weight (0.35 kg) compared to those in a self-directed program (2.40 kg), indicating that structured support can help maintain weight loss after an initial treatment.

The clustered campaign approach allowed participants to maintain 87% of their weight loss, while those in the self-directed group maintained only 64%, highlighting the effectiveness of group-based support in preventing weight regain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of an alternative schedule of extended care contacts to a self-directed control: a randomized trial of weight loss maintenance. Dutton, GR., Gowey, MA., Tan, F., et al.[2021]

In a study involving 738 overweight or obese participants, those in a health management program lost significantly more weight (2.19 kg) and body fat compared to those in a general management group (0.97 kg) after 6 months, indicating the effectiveness of structured health management for weight loss.

The health management program resulted in a higher effective weight loss rate of 24.2% and a body fat loss rate of 52.5%, compared to 11.8% and 34.3% in the general management group, demonstrating its potential as a safe and effective intervention for obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of health management programs on weight among overweight or obese adults]. Wang, Z., Yang, Y., Fu, L., et al.[2018]

A survey of 450 former participants in a community-based weight management program revealed that early discussions about weight loss perceptions are crucial for successful weight loss maintenance (WLM).

To maintain weight loss after a program, individuals should focus on specific behaviors like weekly weighing, limiting evening snacks, controlling portion sizes, and engaging in daily physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of weight loss maintenance following an insurance-sponsored weight management program. Abildso, CG., Schmid, O., Byrd, M., et al.[2021]

Behavioral treatment can effectively lead to a 10% weight loss, which is significant enough to improve health outcomes for patients.

Maintaining weight loss is difficult, but long-term success can be enhanced by increasing patient-provider contact, encouraging physical activity, and combining lifestyle changes with medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of obesity. Butryn, ML., Webb, V., Wadden, TA.[2022]

Short-term behavioral interventions for obesity typically result in an average weight loss of 10 kg during the program and 6.6 kg at one year follow-up, indicating some effectiveness in the short term.

To improve long-term weight management, a chronic disease model of obesity treatment is suggested, emphasizing the need for ongoing care and potentially incorporating highly structured diets and supervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of severe obesity. Wing, RR.[2018]

In a 12-week group weight management program involving 204 participants, individuals lost an average of 6.4 kg (14.1 lbs), achieving over 5% total body weight loss and a significant decrease in BMI by 5.35%.

Participants also experienced notable improvements in quality of life, including enhanced physical function, self-esteem, and reductions in cholesterol and triglyceride levels, indicating the program's effectiveness in addressing obesity and related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A longitudinal study to investigate the effects of a 12-week comprehensive lifestyle weight management program on body weight and quality of life. Langan, A., Bader, A., Goedkoop, S., et al.[2021]

A community-based weight-loss treatment program involving 90 participants led to significant weight loss and sustained health improvements, including reductions in waist circumference and cholesterol levels, over an 18-month period.

Participants maintained their weight loss without significant regain at follow-ups, demonstrating the effectiveness of the program in promoting long-term behavioral and psychological benefits for overweight and obese adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. Latner, JD., Ciao, AC., Wendicke, AU., et al.[2013]

A novel motivation-focused weight loss maintenance program was tested on 338 overweight women over 18 months, showing similar effectiveness in weight loss maintenance compared to a standard skill-based approach, with both groups losing around 5.5% of their body weight.

Both treatment groups significantly outperformed the control group, which only lost 1.51%, indicating that targeting motivation can be an effective strategy in obesity treatment alongside traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A motivation-focused weight loss maintenance program is an effective alternative to a skill-based approach. West, DS., Gorin, AA., Subak, LL., et al.[2022]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

In a study of 36 participants who completed a 10-week behavioral weight control program, most individuals regained a significant amount of weight, averaging 11.94 pounds, and were, on average, heavier than their starting weight after 5 years.

Low adherence to the treatment program after it ended was common, but those who consistently used more program techniques and for longer periods experienced less weight regain, highlighting the importance of ongoing commitment to weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do behavioral treatments of obesity last? A five-year follow-up investigation. Stalonas, PM., Perri, MG., Kerzner, AB.[2019]

Several commercial weight loss programs, including the National Diabetes Prevention Program, WW, Jenny Craig, Medifast, and OPTIFAST, have shown effective and safe 12-month weight loss results, aligning with evidence-based recommendations.

Clinicians are encouraged to refer patients to these programs based on peer-reviewed evidence, while also considering patient preferences and costs, as some other programs still require more evidence for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial Weight Loss Programs in the Management of Obesity: an Update. Laudenslager, M., Chaudhry, ZW., Rajagopal, S., et al.[2022]

Obesity is a significant public health issue that increases the risk of serious health conditions like type 2 diabetes, hypertension, and heart disease, highlighting the importance of effective weight management.

A successful weight loss program should be personalized and may include dietary changes, physical activity, behavior modification, and, for some patients, medications or surgery to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and effective management of the obese patient. Collazo-Clavell, ML.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5503454/

Behavioral Lifestyle Interventions for Moderate and Severe ... This study reviews evidence of behavioral lifestyle interventions for weight loss in this population.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667368124000354

Efficacy of in-person versus digital enhanced lifestyle ... This retrospective study aims to evaluate the weight loss effectiveness of a DELI compared to a structured IPLI. We hypothesized that the interactive web-based ...

3. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/obesity-in-adults-interventions

Weight Loss to Prevent Obesity-Related Morbidity and ... The USPSTF found adequate evidence that behavior-based weight loss interventions in adults with obesity can lead to clinically significant improvements in ...

4. gastroenterologyadvisor.com gastroenterologyadvisor.com/news/virtual-weight-management-program-achieves-sustained-weight-loss-t2d-remission/

Virtual Weight Management Program Achieves Sustained ... Changes in weight at 6, 12, and 18 months were the primary outcomes. The proportion of participants reaching 5%, 10%, 15%, and 20% weight loss ...

5. 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.

6. nyaspubs.onlinelibrary.wiley.com nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15278

Behavior‐change lifestyle interventions for the treatment of ... Most behavior-change lifestyle interventions had moderate effects in reducing obesity outcomes (e.g., body weight, BMI, and BMI z-score).

7. diabetesjournals.org diabetesjournals.org/care/article/48/Supplement_1/S167/157555/8-Obesity-and-Weight-Management-for-the-Prevention

8. Obesity and Weight Management for the Prevention and ... This section aims to provide evidence-based recommendations for obesity management, including behavioral, pharmacologic, and surgical interventions,