Behavioral Weight Loss Treatment for Obesity

(REBOOT Trial)

Overseen By Bradley M Appelhans, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Non-English speakers, Bariatric surgery, Osteoporosis, Cognitive impairment, Active substance abuse, 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: 2

Duration: 6 months

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores why individuals from disadvantaged backgrounds often face greater challenges in losing weight through behavioral programs. Researchers aim to understand how daily challenges and a focus on immediate rewards affect weight loss success. Participants will engage in a 6-month group-based weight loss program (behavioral weight loss treatment) designed by the CDC. Individuals with obesity from either lower or higher socioeconomic backgrounds may be suitable candidates, particularly if they are not currently involved in other weight loss treatments or planning to relocate soon. As an unphased trial, this study provides a unique opportunity to contribute to understanding weight loss challenges and potentially benefit from a tailored program.

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 prior data suggests that this behavioral weight loss treatment is safe?

Research shows that behavioral weight loss programs are generally safe. These programs, which often involve changes in diet and exercise, are usually well-received by participants. For example, one study found that structured support and feedback enabled significant weight loss.

While specific side effects aren't mentioned in the sources, behavioral programs typically pose fewer risks than medications. They focus on lifestyle changes, reducing the chance of negative reactions. Additionally, these programs are widely used and have proven effective for weight loss over time.

In summary, current research supports the safety of behavioral weight loss programs. Participants usually find them manageable, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the behavioral weight loss treatment for obesity because it focuses on lifestyle changes using the CDC's Prevent T2 curriculum. Unlike other treatments that might involve medication or surgery, this approach emphasizes group-based support, which can enhance motivation and accountability. Additionally, the structured six-month program provides a comprehensive framework that encourages sustainable changes in diet and physical activity, potentially leading to long-term success in weight loss and improved health outcomes.

What evidence suggests that this behavioral weight loss treatment might be effective for obesity?

Research has shown that behavioral weight loss programs can effectively help people lose weight. These programs involve changes in diet and exercise, often leading to a loss of about 5% of body weight. A review of several studies found that programs lasting six months or less often result in successful weight loss. Many participants in various studies also lost a significant amount of weight over a year. This trial will evaluate a standard-of-care behavioral weight loss treatment, following the Centers for Disease Control and Prevention's Prevent T2 curriculum, to determine its effectiveness in managing obesity. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

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

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

I am not fluent in English.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral weight loss treatment

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.

How Is the Trial Designed?

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.

Behavioral weight loss treatment is already approved in United States, European Union for the following indications:

Approved in United States as Behavioral weight loss therapy for:

• Obesity
• Overweight

Approved in European Union as Lifestyle modification for weight loss for:

• Obesity
• Overweight
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

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

Behavioral Treatment of Obesity - PMC Adding weight loss medication to comprehensive behavioral treatment significantly improves the induction of weight loss, as demonstrated by several studies. The ...

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

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.

3. link.springer.com link.springer.com/article/10.1007/s13679-024-00552-5

Behavioral Lifestyle Interventions for Weight Loss in ... Our findings suggest that structured BLIs, characterized by frequent feedback and support, can lead to a clinically meaningful 5% weight loss.

4. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... This meta-analysis of 14 RCTs found that interventions lasting 6 months or less were effective at achieving weight loss. Each study showed ...

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

Behavioral Lifestyle Interventions for Moderate and Severe ... Among the 25 behavioral interventions in the 12 studies, 18 reported percent of participants achieving clinically significant weight loss up to 12 months (32–97 ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/article-abstract/2834317

Patient-Delivered Continuous Care for Weight Loss ... In this randomized clinical trial of 287 adults with overweight or obesity, patient-provided weight loss maintenance treatment yielded significantly better ...

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

Intensive Behavioral Therapy for Obesity Intensive behavioral therapy is a treatment for obesity. Through this treatment, you learn how to change your eating and exercise habits.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11150315/

Behavioral Lifestyle Interventions for Weight Loss in ... Our findings suggest that structured BLIs, characterized by frequent feedback and support, can lead to a clinically meaningful 5% weight loss.