What side effects are associated with this type of intervention?

Common treatments for obesity, such as meal replacements and behavioral treatments, generally have a favorable safety profile but can come with some side effects. Meal replacements may lead to gastrointestinal issues like bloating, constipation, or diarrhea due to changes in dietary fiber intake. Behavioral treatments, which often include cognitive-behavioral therapy (CBT) and lifestyle modifications, are generally safe but may cause psychological stress or frustration as patients adjust to new habits. Pharmacotherapy for obesity, while effective, can have more significant side effects, including cardiovascular risks, gastrointestinal disturbances, and potential for weight regain after cessation. Overall, the side effects are typically manageable and should be discussed with a healthcare provider to tailor the treatment to individual needs.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including orlistat, phentermine-topiramate, naltrexone-bupropion, liraglutide, and semaglutide. These medications work through various mechanisms such as appetite suppression, increased satiety, and reduced fat absorption. In addition to pharmacotherapy, behavioral treatments and meal replacements are also recommended for weight maintenance. These approaches emphasize sustainable lifestyle changes, including dietary modifications and physical activity, to support long-term weight management.

What other types of research exist?

Promising novel alternatives for obesity treatment in 2024 include GLP-1 receptor agonists like liraglutide, which have shown significant weight loss benefits. Additionally, combination pharmaceutical compositions such as Contrave® and Qsymia® are emerging as effective options. These alternatives offer new avenues for patients seeking weight maintenance beyond traditional meal replacements and behavioral treatments.

← Back to Search

GLP-1 Receptor Agonist

Strategies to Prevent Weight Regain for Obesity

N/A

Recruiting

Led By Kelseanna Hollis-Hansen, PhD, MPH

Research Sponsored by University of Texas Southwestern Medical Center

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 4-months

Awards & highlights

Summary

This trial tests if special meals or a weight management app can help adults keep off weight after stopping a weight-loss medication. The study focuses on those who have lost significant weight and stopped the medication. The meals make healthy eating easier, and the app provides support for maintaining good habits.

Who is the study for?

This trial is for adults who've lost over 10% of their body weight using GLP-1 receptor agonist medications, have stopped taking these meds within the last month, can consent to participate, and are fluent in English. It's not specified who cannot join.

What is being tested?

The study explores if usual care, medically tailored meals or a digital health program called Noom® can help maintain weight loss after stopping obesity medication (GLP-1s). The goal is to find cost-effective ways to keep the weight off long-term.

What are the potential side effects?

Since this trial tests non-medical interventions like special meals and a health app, side effects may be minimal compared to drug treatments. However, changes in diet or lifestyle adjustments could cause digestive changes or psychological impacts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-months

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

Treatment Details

Study Objectives

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

Primary study objectives

Intervention Adherence

Intervention Satisfaction

Secondary study objectives

Diet quality

Percent weight loss maintained

Other study objectives

Incremental cost effective ratio (ICER)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Noom®Experimental Treatment2 Interventions

Participants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change.

Group II: Medically tailored mealsExperimental Treatment2 Interventions

Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months.

Group III: Usual carePlacebo Group1 Intervention

Participants will receive usual care from their provider.

Do I qualify?Apply below to find out

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 meal replacements and behavioral treatments, work through different mechanisms to promote weight loss and maintenance. Meal replacements provide a controlled, low-calorie alternative to regular meals, helping to reduce overall caloric intake. Behavioral treatments involve strategies like self-monitoring, goal setting, and developing coping skills to modify eating behaviors and lifestyle habits. These approaches are crucial for obesity patients as they offer structured and sustainable methods to manage weight, addressing both dietary intake and behavioral factors that contribute to obesity.

Post-operative behavioural management in bariatric surgery: a systematic review and meta-analysis of randomized controlled trials.

Find a Location

Who is running the clinical trial?

UT Southwestern Nutrition Obesity Research CenterUNKNOWN

University of Texas Southwestern Medical CenterLead Sponsor

1,072 Previous Clinical Trials

1,056,202 Total Patients Enrolled

24 Trials studying Obesity

5,489 Patients Enrolled for Obesity

Kelseanna Hollis-Hansen, PhD, MPHPrincipal InvestigatorUT Southwestern Medical Center

2 Previous Clinical Trials

245 Total Patients Enrolled

~20 spots leftby Dec 2024

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.