Behavioral Program for Weight Loss

Recruiting at 1 trial location

Overseen By ADAPT Study

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Weight loss medications, Antipsychotics, Stimulants, Anticoagulants

Disqualifiers: Smoking, Heavy alcohol use, Diabetes, 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: 7

90 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 hit a weight loss plateau, even with continued efforts to lose weight. Participants will join a Behavioral Weight Loss Program to examine how changes in metabolism or brain activity might influence this plateau. The trial seeks individuals with a BMI between 30 and 50 who live independently and can attend classes and study visits. Non-smokers who do not use drugs heavily and have not experienced certain medical conditions like diabetes or a stroke may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on weight loss challenges.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that significantly affect appetite, such as weight loss medications, atypical antipsychotics, and stimulants, as well as chronic use of anticoagulants.

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

Research has shown that behavioral weight loss programs are generally safe and easy to follow. These programs emphasize healthy lifestyle changes, such as diet and exercise, while avoiding risky weight-loss methods.

For example, intensive behavioral therapy for obesity has proven effective in helping people lose weight safely. This method supports gradual and safe weight loss. Studies also indicate that these programs help maintain weight loss by promoting ongoing healthy habits.

Overall, evidence suggests that joining a behavioral weight loss program is a safe choice for those seeking to lose weight through lifestyle changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Weight Loss Program because it emphasizes changing daily habits and behaviors, which is different from traditional treatments like medications or surgery. This approach focuses on sustainable lifestyle changes, potentially offering long-term weight management without the side effects associated with pharmaceuticals. Additionally, the program encourages personal empowerment and self-monitoring, which can lead to better adherence and improved outcomes compared to more passive treatments.

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

Research has shown that programs focused on changing behavior can help people lose weight effectively. Participants in the Behavioral Weight Loss Program, the focus of this trial, often lose about 8–10 kg, or around 8–10% of their starting weight. Studies have found that these programs help maintain weight loss over time. Intensive behavioral therapy, which emphasizes healthy eating and regular exercise, works well without involving any risky methods. Overall, these programs offer a reliable and proven way to lose weight and maintain it. ^{4 6 7 8 9}

Who Is on the Research Team?

Ellen Schur, MD, MS

Principal Investigator

University of Washington

Marian L. Neuhouser

Principal Investigator

Fred Hutch Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who are experiencing obesity and want to lose weight. Participants should be willing to follow a Behavioral Weight Loss Program but have hit an involuntary weight loss plateau despite their efforts.

Inclusion Criteria

BMI 30.0 - 50.0 kg/m2

I can attend all required study classes and visits.

Independently living with access to food preparation facilities

Exclusion Criteria

MRI contraindication (e.g., implanted metal, claustrophobia)

Do not have a phone compatible with activity tracker or access to videoconferencing platform that will be used for the dietary intervention or other appropriate technology needed to complete study procedures

Any condition(s) found by the study team and confirmed with the PI(s) that make it unsafe to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Initial Study Visits

Participants complete 3 in-person study visits for baseline assessments including questionnaires, blood draws, brain MRIs, body measurements, DXA scans, breathing tests, and biopsies.

4-6 weeks

3 visits (in-person)

Weight Loss Program

Participants undergo a 6-month behavioral weight loss program delivered remotely.

6 months

Remote participation

Additional Study Visits

Some participants may be invited to complete 3 additional in-person visits for further assessments.

Variable

3 visits (in-person)

Follow-up

Participants are monitored for physiological changes and weight loss plateau occurrence.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Weight Loss Program

Trial Overview The study is examining why people stop losing weight after initial success with a Behavioral Weight Loss Program, focusing on changes in metabolism and brain function that might cause this plateau.

How Is the Trial Designed?

Group I: Behavioral Weight Loss Experimental Treatment 1 Intervention

Participants will undergo a behavioral weight loss program.

Behavioral Weight Loss Program is already approved in United States, European Union for the following indications:

Approved in United States as Behavioral Weight Loss Program for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Behavioral Weight Loss Interventions for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Comprehensive behavioral weight loss programs have evolved to include systematic work on various factors such as eating behavior, exercise, attitudes, and social relationships, leading to significant weight losses of 25 to 30 pounds.

The most notable strength of these behavioral programs is their effectiveness in maintaining weight loss over time, which is crucial for long-term success in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral management of obesity. Brownell, KD., Kramer, FM.[2019]

In a study of 881 participants in a 2-year weight management program, those who completed the program showed significant reductions in BMI over 3 years, with mean decreases of 11.8 kg/m2 at 1 year, 8.6 kg/m2 at 2 years, and 5.2 kg/m2 at 3 years.

Early attrition negatively impacted weight loss outcomes, with individuals who dropped out early losing 13% less BMI than completers at 1 year, highlighting the importance of addressing attrition in evaluating the effectiveness of weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attrition Bias in an Observational Study of Very Low-Energy Diet: A Cohort Study. Isaman, DJM., Herman, WH., Rothberg, AE.[2022]

In a study of 236 participants from the POWER Hopkins Trial, individual telephone sessions, online weight tracking, and coach reviews were rated as the most helpful components of a behavioral weight loss program, indicating their effectiveness in supporting weight loss efforts.

Demographic factors influenced perceptions of helpfulness, with older adults, Black participants, and those with lower education levels finding the intervention components more beneficial, suggesting the need for tailored approaches in weight loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Dalcin, AT., Jerome, GJ., Fitzpatrick, SL., et al.[2021]

The comprehensive obesity treatment program, which includes nutritional education, exercise, and mental conditioning, resulted in significant weight loss, with over 18 kg (40 lb) lost by three out of four patients.

Long-term success in maintaining weight loss requires patient adherence to lifestyle modifications over six months to a year, highlighting the importance of a strong partnership between the physician and patient for effective rehabilitation rather than a complete cure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary approach to adult obesity therapy. Blackburn, GL., Greenberg, I.[2014]

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]

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]

A behavioral approach to treating obesity, guided by the nursing process, has been shown to effectively help clients lose weight and maintain their weight loss in outpatient settings.

Key components of this approach include assessing motivation and behaviors, creating realistic treatment plans, and using intervention techniques like stimulus control and problem solving, all of which are crucial for successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral intervention for the obese client. White, JH.[2019]

A comprehensive analysis of 169 randomized controlled trials found that specific components of behavioral weight management programs (BWMPs) significantly contribute to weight loss, including dietary changes and meal replacements, with average weight reductions ranging from 1.05 kg to 2.63 kg.

Programs delivered by psychologists or dietitians and those conducted in home settings also showed clinically significant benefits, suggesting that the expertise of the provider and the environment can enhance the effectiveness of weight management interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of program characteristics on weight loss in adult behavioral weight management interventions: systematic review and component network meta-analysis. Hartmann-Boyce, J., Ordóñez-Mena, JM., Theodoulou, A., et al.[2022]

A randomized controlled trial involving 88 patients with morbid obesity demonstrated that multistep cognitive behavioral therapy for obesity (CBT-OB) led to a significant mean weight loss of 15% after 12 months, with no weight regain observed between months 6 and 12.

CBT-OB has shown promising long-term results for managing obesity related to binge-eating disorder, and ongoing outpatient studies may further validate its effectiveness compared to standard weight-loss programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized multistep cognitive behavioral therapy for obesity. Dalle Grave, R., Sartirana, M., El Ghoch, M., et al.[2020]

An interdisciplinary comprehensive weight loss program, combined with a biweekly behavioral maintenance program, helped participants maintain 83% of their initial weight loss after 18 months.

This multi-disciplinary approach, which includes social support and aerobic exercise, is considered the best current treatment for obesity, providing significant long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment of obesity: a behavioral medicine perspective. Pera, V., Clark, MM., Abrams, DB.[2005]

In a low-intensity, employer-sponsored weight loss program involving 3 counseling calls and a comprehensive website, one third of participants lost at least 5% of their body weight after six months, indicating the program's efficacy.

Utilization of both counseling and the website, particularly the weight tracking tool, was linked to successful weight loss, along with positive health behavior changes like increased fruit and vegetable intake and physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and utilization of a low intensity workplace weight loss program. Carpenter, KM., Lovejoy, JC., Lange, JM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3233993/

Behavioral Treatment of Obesity - PMC Participants treated with a comprehensive behavioral approach lose approximately 8–10 kg, equal to 8–10% of initial weight. Approximately 80% of patients who ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702878

Behavioral Weight Loss Interventions to Prevent Obesity ... The USPSTF found adequate evidence that behavior-based weight loss maintenance interventions are of moderate benefit. The USPSTF found adequate ...

3. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/intensive-behavioral-therapy-for-obesity

Intensive Behavioral Therapy for Obesity Most people find that intensive behavioral therapy can be part of a successful weight-loss plan. This therapy doesn't use any risky weight-loss techniques.

4. cms.gov cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=353

NCD - Intensive Behavioral Therapy for Obesity (210.12) Intensive behavioral counseling and behavioral therapy to promote sustained weight loss through high intensity interventions on diet and exercise. The intensive ...

5. health.harvard.edu health.harvard.edu/blog/behavioral-weight-loss-interventions-do-they-work-in-primary-care-202209212820

Behavioral weight loss interventions: Do they work in ... The interventions included instruction on weight management behaviors such as low-calorie diets, increased exercise, use of food diaries, and/or behavioral ...

6. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Intensive%20Behavioral%20Therapy%20for%20Obesity&NCAId=253

Decision Memo - Intensive Behavioral Therapy for Obesity Orlistat plus behavioral intervention resulted in 3-kg (6.6-lb) more weight loss than did placebo after 12 months. Metformin resulted in less ...

7. aafp.org aafp.org/pubs/afp/issues/2019/0415/od1.html

Behavioral Weight Loss Interventions to Prevent Obesity ... Behavior-based weight loss maintenance trials were designed to maintain weight loss by continuing dietary changes and physical activity.

8. 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.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT00746265?tab=table

NCT00746265 | Behavioral Treatment for Weight Loss This project compares gold standard cognitive-behavioral therapy (based on LEARN, Diabetes Prevention Program, LOOK Ahead) used in both research and clinical ...