Behavioral Weight Loss Treatment for Obesity

(REBOOT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

Disqualifiers: Non-English speakers, Bariatric surgery, Osteoporosis, Cognitive impairment, Active substance abuse, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to understand why people with lower income have more difficulty losing weight. Participants will follow a typical weight loss program, and researchers will study how focusing on immediate needs and daily stress affect their success. The goal is to find better ways to help these individuals stick to their weight loss plans.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently engaged in another weight loss therapy, you cannot participate.

What data supports the effectiveness of the treatment for obesity?

Research shows that behavioral weight loss treatments can help people lose about 10% of their body weight, which can significantly improve health. These treatments often include changes in diet, exercise, and behavior, and have been successful in helping people maintain weight loss over time. ^{1 2 3 4 5}

Is behavioral weight loss treatment safe for humans?

Behavioral weight loss treatments, which include changes in diet, physical activity, and behavior, are generally considered safe for humans. They focus on helping people adopt healthier habits and have been used successfully to manage obesity without significant safety concerns. ^{5 6 7 8 9}

How is behavioral weight loss treatment different from other obesity treatments?

Behavioral weight loss treatment is unique because it focuses on changing eating, activity, and thinking habits through techniques like self-monitoring and cognitive restructuring, rather than relying solely on medication or surgery. It emphasizes long-term lifestyle changes and can be combined with other methods for better results. ^{2 6 10 11 12}

Research Team

Eligibility Criteria

This trial is for adults over 18 with obesity (BMI ≥30 kg/m2) who fall into specific socioeconomic status (SES) groups. Participants must live within 20 miles of Rush and have phone access. Those with a BMI over 60, severe medical conditions, cognitive impairments, substance abuse issues, or not fluent in English cannot join.

Inclusion Criteria

I am 18 years old or older.

Meets criteria for either the lower SES or higher SES cohort

I am considered obese based on my BMI.

Exclusion Criteria

Lack of reliable access to cell or landline phone

Resides more than 20 miles away from Rush, or planning to move outside of this geographic area during the study period

I am not fluent in English.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of group-based behavioral weight loss treatment following the CDC Prevent T2 curriculum

6 months

Monthly group sessions

Follow-up

Participants are monitored for weight change and adherence to weight control behaviors

6 months

Assessments at months 2, 4, and 6

Treatment Details

Interventions

• Behavioral weight loss treatment (Behavioral Intervention)

Trial Overview The study is examining how daily adversities and 'present bias'—a focus on immediate needs due to unstable environments—affect the success of behavioral weight loss treatments among individuals from different socioeconomic backgrounds.

Participant Groups

Group I: Standard-of-care behavioral weight loss treatment Experimental Treatment 1 Intervention

6-months of group-based behavioral weight loss treatment following the Centers for Disease Control and Prevention Prevent T2 curriculum.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Dr. Omar B. Lateef

Rush University Medical Center

Chief Executive Officer since 2022

MD from Des Moines University, Fellowship in Pulmonary and Critical Care Medicine at Rush University Medical Center

Dr. Paul E. Casey

Rush University Medical Center

Chief Medical Officer since 2021

MD, MBA

Findings from Research

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]

Behavior modification for obesity treatment has evolved to systematically address various factors influencing eating and exercise, leading to an average weight loss of 9.9 kg over an 18-week treatment period.

Approximately 66% of the weight lost is maintained after one year, highlighting the need for longer-term strategies to prevent relapse in obesity, as it is a chronic condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for success of behavior modification in weight loss and control. Foreyt, JP., Goodrick, GK.[2019]

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]

A 29-year-old man successfully lost weight through a behavior therapy approach that included monitoring his eating and exercise habits, correcting misconceptions, and developing strategies for healthier living.

The weight loss achieved during treatment was significant and maintained at a 6-month follow-up, demonstrating the long-term efficacy of behavior therapy for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment of obesity exemplified in a case study. Wyshogrod, D.[2019]

Weight loss of just 5-10% can significantly improve health issues related to obesity, such as hypertension and type II diabetes, as shown in studies like the Diabetes Prevention Program, which found a 7% weight reduction reduced diabetes risk by 58%.

Behavioral treatments, which include diet changes, increased physical activity, and behavior therapy, are effective in achieving and maintaining this level of weight loss, promoting long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. Jones, LR., Wilson, CI., Wadden, TA.[2007]

Behavioral treatment for obesity focuses on changing eating, activity, and thinking habits, acknowledging that weight is influenced by genetics, metabolism, and hormones.

This approach equips individuals with skills for managing weight, such as adopting a low-fat diet and increasing physical activity, although many may still be overweight after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of obesity. Wadden, TA., Butryn, ML.[2019]

An eight-week study involving 101 overweight participants showed that an internet-based behavioral therapy program (IBT) led to significantly greater weight loss (2.28 kg) compared to a standard email education program (0.74 kg).

Participants in the IBT group were also more successful in achieving a clinically significant weight loss of 5% of their initial body weight (17.6% vs. 2%), indicating that structured online interventions can be effective for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an Internet-Based Turkish Obesity Behavioral Therapy Program: A Randomized Study. Hepdurgun, C., Özalay, Ö., Pırıldar, Ş., et al.[2022]

Lifestyle modifications, including changes in diet and increased physical activity, are essential for treating obesity and reducing the risk of related cardiovascular diseases.

Behavior modification techniques, such as self-monitoring and cognitive restructuring, are effective strategies for changing obesity-related behaviors, and medication can also support these lifestyle changes in managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful management of the obese patient. Poston, WS., Foreyt, JP.[2019]

Behavior therapy for obesity has evolved over the past 30 years, leading to increased average weight loss, but many individuals still struggle with regaining weight after treatment.

The study suggests that obesity should be viewed as a chronic health issue, and long-term behavior therapy programs may be crucial for helping some individuals maintain their weight loss over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral therapy for obesity. Williamson, DA., Perrin, LA.[2019]

Behavioral treatment for obesity can lead to an average weight loss of 8.5 kg (about 9% of initial weight) over approximately 20 weeks, highlighting its efficacy in helping individuals change unhealthy habits.

Combining behavioral strategies with weight-loss medications enhances the chances of successful weight maintenance, emphasizing the importance of a comprehensive approach to obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of obesity. Wadden, TA., Foster, GD.[2019]

Behavioral therapy is a key part of obesity treatment, focusing on self-monitoring and various techniques like stimulus control and cognitive restructuring, but most patients tend to regain weight over time, highlighting the need for long-term strategies.

To improve long-term success, behavioral therapy can be supplemented with other treatments like very-low-calorie diets or medications, and it's important to tailor approaches to individual needs, especially for subgroups like those with binge eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of behavioral therapy in the management of obesity. Yanovski, SZ., Devlin, MJ.[2021]

Behavior therapy is a widely utilized approach for treating obesity, supported by extensive medical literature.

The study identifies and lists 49 key elements of behavioral weight control, derived from five major publications, highlighting the diverse strategies employed in this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavior therapy? A very short description of behavioral weight control. Stunkard, AJ., Berthold, HC.[2018]

References

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

Behavioral treatment of obesity. [2022]

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

Evidence for success of behavior modification in weight loss and control. [2019]

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

Behavioral treatment of severe obesity. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Current treatment of obesity exemplified in a case study. [2019]

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

Lifestyle modification in the treatment of obesity: an educational challenge and opportunity. [2007]

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

Behavioral treatment of obesity. [2019]

7. Turkey pubmed.ncbi.nlm.nih.gov

Testing an Internet-Based Turkish Obesity Behavioral Therapy Program: A Randomized Study. [2022]

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

Successful management of the obese patient. [2019]

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

Behavioral therapy for obesity. [2019]

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

Behavioral treatment of obesity. [2019]

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

Role of behavioral therapy in the management of obesity. [2021]

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

What is behavior therapy? A very short description of behavioral weight control. [2018]