What side effects are associated with this type of intervention?

Common treatments for obesity, such as glucagon-like peptide-1 receptor agonists, sibutramine, and topiramate, have various side effects. Glucagon-like peptide-1 receptor agonists are generally well-tolerated but can cause gastrointestinal symptoms like nausea. Sibutramine has been associated with significant weight loss but can also lead to increased heart rate and blood pressure. Topiramate, used in some cases, may cause cognitive side effects such as memory issues and difficulty concentrating. Behavioral weight loss interventions typically do not have direct physical side effects but may be influenced by socio-economic factors and psychological stressors, which can impact their effectiveness.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including lorcaserin and sibutramine. Lorcaserin was withdrawn from the market in 2020 due to an increased risk of cancer. Sibutramine was removed in 2010 because of its association with higher risks of nonfatal myocardial infarction and stroke. These drugs were intended to complement behavioral weight loss interventions, which focus on lifestyle changes such as diet and exercise. However, due to their adverse effects, their use has been discontinued, highlighting the importance of safer pharmacological options in conjunction with behavioral therapies.

What other types of research exist?

Promising novel alternatives to traditional Behavioral Weight Loss Interventions for obesity patients include: 1) Cognitive-behavioral therapy (CBT) tailored to address present bias and adverse daily experiences, 2) Pharmacotherapy options such as naltrexone/bupropion combination therapy, which has shown efficacy in weight management, 3) Digital health interventions and mobile apps that provide real-time support and personalized feedback, and 4) Integrative approaches combining nutritional, psychological, and pharmacological treatments to address the multifaceted nature of obesity.

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Behavioral Intervention

Behavioral Weight Loss Treatment for Obesity (REBOOT Trial)

N/A

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years old

Obesity (body mass index ≥30 kg/m2)

Must not have

Not fluent in English

History of bariatric surgery, or current engagement in another weight loss therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 2, 4, and 6

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a behavioral treatment study focusing on lifestyle changes rather than medication or surgery, side effects are minimal but may include potential stress or discomfort related to changing long-standing habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am considered obese based on my BMI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not fluent in English.

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I have had weight loss surgery or am currently trying to lose weight through another method.

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I do not have severe health issues like advanced heart failure, cancer, or kidney failure that would prevent me from joining.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 2, 4, and 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 2, 4, and 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 2, 4, and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight change

Secondary study objectives

Adherence to dietary self-monitoring

Adherence to physical activity recommendations

Frequency of dietary lapses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard-of-care behavioral weight loss treatmentExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include behavioral weight loss interventions and pharmacotherapy. Behavioral interventions focus on modifying eating and physical activity habits through self-monitoring, goal setting, and addressing cognitive distortions, which help patients develop healthier behaviors and cope with adverse daily experiences and present bias. Pharmacotherapy, such as GLP-1 receptor agonists like liraglutide and semaglutide, reduces appetite and increases satiety, aiding in caloric intake management. Understanding these mechanisms helps obesity patients select the most suitable treatment based on their unique needs and challenges.

Implementing family-based behavioral treatment in the pediatric primary care setting: Design of the PLAN study.Psychological approaches to chronic pain management: evidence and challenges.From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases.