What side effects are associated with this type of intervention?

Common treatments for obesity, such as lifestyle interventions involving environmental control and impulse control training, generally have minimal side effects. These approaches focus on behavioral changes, dietary modifications, and increased physical activity, which are safe but may require sustained effort and motivation. Pharmacological treatments, often used alongside lifestyle changes, can have side effects such as gastrointestinal issues (e.g., nausea, diarrhea), and in some cases, more severe effects like cardiovascular problems. It is important to discuss these options with a healthcare provider to tailor the treatment plan to individual needs and minimize potential side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including exenatide and dulaglutide, which are GLP-1 receptor agonists used to improve glycemic control and support weight loss. Sibutramine, an appetite suppressant, was removed from the market due to cardiovascular risks. Lorcaserin, which acts on serotonin receptors to promote satiety, was also withdrawn due to an increased risk of cancer. The combination of bupropion-naltrexone, which targets both the hypothalamic appetite regulation and the reward system, is approved but not typically first-line due to cardiovascular safety concerns. These pharmacological treatments complement behavioral strategies like those studied in the AVOID (environmental control) and RESIST (impulse control training) trials.

What other types of research exist?

Promising novel alternatives for obesity treatment in 2024 include: 1) Virtual Reality (VR) technology for immersive behavioral therapy, 2) Cognitive-Behavioral Therapy (CBT) tailored for weight management, and 3) Pharmacological advancements such as GLP-1 receptor agonists (e.g., liraglutide) for appetite regulation and metabolic improvement.

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Avoid and Resist Strategies for Weight Management

N/A

Recruiting

Led By Sarah-Jeanne Salvy, PhD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

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

Must have

14-years-old

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month, 12-month

Awards & highlights

No Placebo-Only Group

Summary

This trial tests two methods to help people with overweight or obesity lose weight and eat healthier. One method changes the home food environment to make healthier choices easier (AVOID), and the other improves self-control over food choices through training (RESIST).

Who is the study for?

This trial is for adults and children over 14 with obesity, having a BMI between 25-40. Participants must be able to read, write, and speak English with good vision. Children under 18 need parent consent. It's aimed at those willing to complete various assessments.

What is being tested?

The study is testing two weight management strategies: AVOID involves changing the home food environment and grocery delivery; RESIST focuses on training to control impulses. The effectiveness of these against WW (formerly Weight Watchers) will be compared.

What are the potential side effects?

Since this trial involves dietary changes and behavioral training rather than medication, side effects may include psychological stress or frustration due to lifestyle adjustments. Physical side effects are not expected from the interventions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 14 years old.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month, 12-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month, 12-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month, 12-month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in BMI from baseline to 12 months.

Secondary study objectives

Diet quality assessed by 24h-dietary recall

Other study objectives

Changes in Health and Lifestyle.

Continuous Performance Task Go/No-Go

Demographics

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: WW + Inhibitory control training (RESIST)Experimental Treatment2 Interventions

WW + daily gamified inhibitory control training

Group II: WW + Home modification and grocery delivery (AVOID)Experimental Treatment2 Interventions

WW + modification of home food environment + online grocery shopping and delivery

Group III: WW + Home food modification and grocery delivery (AVOID) + Inhibitory control training (RESIST)Experimental Treatment3 Interventions

WW + modification of home food environment + online grocery shopping and delivery + daily gamified inhibitory control training

Group IV: WW OnlyActive Control1 Intervention

WW is commercially-available weight management program focusing on diet, physical activity and mindset skills.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

2020

N/A

~360

0 / 2Eligibility 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 lifestyle interventions, pharmacotherapy, and behavioral strategies. Lifestyle interventions focus on dietary changes and increased physical activity to reduce caloric intake and increase energy expenditure. Pharmacotherapy often involves medications that suppress appetite or inhibit fat absorption. Behavioral strategies, such as those in the AVOID (Environmental Control) and RESIST (Impulse Control Training) trials, aim to modify the environment to reduce exposure to high-calorie foods and train individuals to resist impulsive eating behaviors. Understanding these mechanisms is crucial for obesity patients as it helps them choose the most effective treatment tailored to their habits and needs, ultimately improving adherence and outcomes.

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