What is the mechanism of action of this treatment?

Common treatments for obesity, such as those studied in Behavioral Weight Loss Interventions (BWLI), focus on cognitive strategies, self-monitoring, and behavioral modification. These interventions work by encouraging patients to monitor their food intake and physical activity, set realistic goals, and develop problem-solving skills. They also aim to modify dysfunctional thoughts related to eating and body image. By increasing awareness of behaviors and identifying triggers for overeating, these strategies help patients adopt healthier habits. This approach is crucial for obesity patients as it promotes sustainable lifestyle changes and improves overall health outcomes.

What side effects are associated with this type of intervention?

Common side effects of behavioral weight loss interventions, such as those involving internet-delivered cognitive strategies and self-monitoring, are generally minimal. They can include initial discomfort or frustration with self-monitoring, increased anxiety or stress related to dietary changes, and temporary fatigue or muscle soreness from increased physical activity. Adherence challenges may also lead to feelings of discouragement for some individuals.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including semaglutide, liraglutide, and orlistat. Semaglutide and liraglutide are glucagon-like peptide-1 (GLP-1) receptor agonists that have shown significant efficacy in weight loss. Orlistat works by inhibiting fat absorption in the gut. These medications are often used in conjunction with lifestyle interventions such as diet, exercise, and behavioral modifications, including cognitive strategies and self-monitoring, which are similar to the approaches studied in internet-delivered weight loss programs.

What other types of research exist?

Promising, novel alternatives to Behavioral Weight Loss Interventions for obesity patients in 2024 include: 1) Pharmacological treatments such as GLP-1 receptor agonists (e.g., semaglutide) which have shown significant weight loss in clinical trials. 2) Digital therapeutics, including smartphone apps and telehealth platforms that provide personalized weight management programs. 3) Bariatric endoscopic procedures, which are less invasive than traditional surgery and have shown effectiveness in weight reduction. 4) Combination therapies that integrate pharmacological treatments with cognitive-behavioral therapy to enhance adherence and outcomes.

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Behavioral Strategies for Weight Loss

N/A

Recruiting

Research Sponsored by The Miriam Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after randomization

Awards & highlights

Summary

This trial compares three online programs designed to help adults with obesity lose weight. Each program includes lessons, tracking of food and exercise, and strategies to change thinking about eating and activity. The goal is to find out which program works best and understand how they affect weight-related behaviors.

Who is the study for?

This trial is for adults aged 18-70 with obesity (BMI of 25-45) who have regular internet access. It's not for those in other weight loss programs, pregnant or nursing individuals, people planning to move away, or those with certain medical conditions without doctor approval.

What is being tested?

The study compares three online weight loss programs: STANDARD Behavioral Weight Loss Intervention and two others focusing on different cognitive strategies (PREVENT and PROMOTE). Participants will follow a year-long program with assessments at various stages.

What are the potential side effects?

Potential adverse outcomes may include depression, increased body image concerns, or weight stigmatization. However, these are not direct side effects of the interventions but possible psychological impacts from participating in the weight loss programs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after randomization for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percent Weight Change Post-Treatment

Percent Weight Change at 12 months

Percent Weight Change at 3 months

+1 more

Secondary study objectives

Change in Actigraph-measured Physical Activity (PA)

Change in Dietary Recall

Intervention Adherence - lessons viewed

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: PROMOTEExperimental Treatment1 Intervention

This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and activity daily via a study website. Additionally, PROMOTE uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term benefits of healthy choices. Participants will receive cognitive training in PROMOTE prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and activity behaviors. These lessons and individualized feedback to participants are framed according to PROMOTE (i.e., focusing on achieving long-term benefits of healthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month), and feedback.

Group II: PREVENTExperimental Treatment1 Intervention

This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Additionally, PREVENT uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term negative consequences of unhealthy choices. Participants will receive training in PREVENT strategies prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants are framed according to PREVENT (i.e., focusing on avoiding long-term consequences of unhealthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training session at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.

Group III: STANDARD BehavioralActive Control1 Intervention

This is a 12-month Internet-delivered behavioral weight loss (iBWL) program that has been used in numerous studies and is currently considered our 'standard' treatment. Participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Participants will have a training session prior to beginning iBWL to learn about the website and their specific weight-related goals. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants incorporate key BWL strategies. Participants will then have a 'refresher' training session at 3 months to discuss standard behavioral weight loss strategies and help control for contact across arms. For the remainder of the program (months 4-12) participants will have monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.

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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, such as those studied in Behavioral Weight Loss Interventions (BWLI), focus on cognitive strategies, self-monitoring, and behavioral modification. These interventions work by encouraging patients to monitor their food intake and physical activity, set realistic goals, and develop problem-solving skills. They also aim to modify dysfunctional thoughts related to eating and body image. By increasing awareness of behaviors and identifying triggers for overeating, these strategies help patients adopt healthier habits. This approach is crucial for obesity patients as it promotes sustainable lifestyle changes and improves overall health outcomes.

From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases.Subgrouping of low back pain patients for targeting treatments: evidence from genetic, psychological, and activity-related behavioral approaches.The effectiveness of psychosocial modalities in the treatment of alcohol problems in adults: a review of the evidence.

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER

463 Previous Clinical Trials

618,333 Total Patients Enrolled

19 Trials studying Obesity

9,620 Patients Enrolled for Obesity

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

2,410 Previous Clinical Trials

4,324,531 Total Patients Enrolled

459 Trials studying Obesity

589,190 Patients Enrolled for Obesity

The Miriam HospitalLead Sponsor

243 Previous Clinical Trials

37,347 Total Patients Enrolled

75 Trials studying Obesity

14,736 Patients Enrolled for Obesity

Media Library

PREVENT Behavioral Weight Loss Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05799846 — N/A

Obesity Research Study Groups: PROMOTE, PREVENT, STANDARD Behavioral

Obesity Clinical Trial 2023: PREVENT Behavioral Weight Loss Intervention Highlights & Side Effects. Trial Name: NCT05799846 — N/A

PREVENT Behavioral Weight Loss Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05799846 — N/A

~189 spots leftby May 2026

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