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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the physiological basis for the differences in weight regain among adults (25-59 years old) with obesity following participation in a behavioral weight loss program. Eligible participants will undergo a baseline evaluation after which they will enter an up to 20 week behavioral weight loss program with the goal of losing at least 7 percent of their baseline weight within 37 weeks. Participants who meet the weight loss goal will be asked to remain weight stable for 2 weeks after which they will undergo a clinical examination. They will then be observed for 1 year during which they will undergo 2 additional clinical examinations, one 4 months after completing the weight loss program, and the other 12 months after completing the weight loss program.

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 data supports the effectiveness of this weight loss treatment?

Research shows that behavioral treatments for obesity can lead to significant weight loss, with programs often resulting in a 10% reduction in body weight, which improves health. Long-term success is more likely when patients have ongoing support, engage in regular physical activity, and combine lifestyle changes with other interventions. ^{1 2 3 4 5}

Is the Weight Loss Maintenance for Obesity treatment safe for humans?

Research on various weight loss programs, including community-based and commercial ones, shows that they are generally safe for humans. Participants in these programs experienced sustained weight loss and improvements in health markers like cholesterol and quality of life, with high satisfaction and adherence to treatment protocols. ^{6 7 8 9 10}

How is the Weight Loss Maintenance for Obesity treatment different from other treatments?

This treatment is unique because it focuses on a behavioral weight loss program that combines lifestyle changes, such as diet and physical activity, with education to support long-term weight management. Unlike some other treatments, it emphasizes extended care and motivation to help maintain weight loss over time. ^{1 5 9 11 12}

Research Team

Steven Belle, PhD

Principal Investigator

University of Pittsburgh

Dympna Gallagher, EdD

Principal Investigator

Columbia University

Susan Roberts, PhD

Principal Investigator

Dartmouth College

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2021]

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

Behavioral treatment of severe obesity. [2018]

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

Behavioral treatment of obesity. [2022]

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

Safe and effective management of the obese patient. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Community-based behavioral weight-loss treatment: long-term maintenance of weight loss, physiological, and psychological outcomes. [2013]

7. China pubmed.ncbi.nlm.nih.gov

[Effects of health management programs on weight among overweight or obese adults]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Do behavioral treatments of obesity last? A five-year follow-up investigation. [2019]

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

Commercial Weight Loss Programs in the Management of Obesity: an Update. [2022]

10. England 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. [2021]

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

Predictors of weight loss maintenance following an insurance-sponsored weight management program. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A motivation-focused weight loss maintenance program is an effective alternative to a skill-based approach. [2022]