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

Trial Summary

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 data supports the effectiveness of the treatment Behavioral Weight Loss Program?

Research shows that behavioral treatments can lead to a 10% weight loss, which improves health, and a comprehensive program can maintain 83% of initial weight loss after 18 months. Additionally, multistep cognitive behavioral therapy has resulted in a 15% weight loss over 12 months, with promising long-term results. ^{1 2 3 4 5}

Is the Behavioral Program for Weight Loss safe for humans?

The research does not specifically address safety concerns, but behavioral weight loss programs are generally considered safe as they focus on lifestyle changes like diet and exercise, which are typically low-risk. ^{5 6 7 8 9}

How is the Behavioral Weight Loss Program treatment different from other treatments for obesity?

The Behavioral Weight Loss Program is unique because it focuses on changing behaviors related to eating, exercise, and attitudes, rather than just diet or exercise alone. It involves a comprehensive approach that includes mental conditioning and social support, which helps maintain weight loss over time. ^{1 5 6 10 11}

What is the purpose of this trial?

Behavioral weight loss programs for obesity can result in weight loss and health benefits. However, behavioral weight loss often stops despite efforts to continue losing weight, this can be called an involuntarily weight loss plateau. This study investigates changes in metabolism and/or the brain that contribute to the occurrence of an involuntary weight loss plateau.

Research Team

Marian L. Neuhouser

Principal Investigator

Fred Hutch Cancer Center

Ellen Schur, MD, MS

Principal Investigator

University of Washington

Jenny Tong, MD

Principal Investigator

University of Washington/VA Puget Sound

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

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

Current treatment of obesity: a behavioral medicine perspective. [2005]

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

Behavioral treatment of obesity. [2022]

3. 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]

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

Behavioral intervention for the obese client. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Personalized multistep cognitive behavioral therapy for obesity. [2020]

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

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. [2021]

7. United States 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. [2022]

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

Outcomes and utilization of a low intensity workplace weight loss program. [2021]

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

Attrition Bias in an Observational Study of Very Low-Energy Diet: A Cohort Study. [2022]

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

Behavioral management of obesity. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary approach to adult obesity therapy. [2014]