Strategies to Prevent Weight Regain for Obesity

Overseen By Kelseanna Hollis-Hansen, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: GLP-1s

Disqualifiers: Psychiatric illness, Substance misuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people maintain weight loss after discontinuing GLP-1 medications (GLP-1 receptor agonists), commonly used for weight management. The research tests whether meal replacements or a mobile app called Noom® can better sustain weight loss compared to usual care. It seeks more affordable and sustainable methods to prevent weight regain. This trial may suit individuals who recently lost over 10% of their weight using GLP-1 medications and stopped within the last month. As an unphased trial, it offers a unique opportunity to explore innovative strategies for maintaining weight loss.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on people who have recently stopped taking GLP-1 receptor agonist medications. It seems likely that you should have already stopped taking GLP-1s to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GLP-1 receptor agonists are generally safe for weight loss. Studies have found these medications to be well-tolerated and often recommended by doctors for treating obesity. However, some individuals might experience mild side effects like nausea or diarrhea.

Evidence suggests that medically tailored meals are safe and can improve health for people with diet-related issues. These meals, customized to meet individual nutritional needs, have been linked to better health outcomes.

The Noom program, a digital app for weight management, is also considered safe. It uses psychology to help change eating habits. Studies report that it aids in weight loss and is generally well-liked by users.

Overall, participants can feel confident about the safety of these treatments based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer diverse strategies to help prevent weight regain in individuals with obesity. Medically tailored meals provide participants with personalized nutrition, which can make maintaining a healthy diet easier and more sustainable. Noom® offers a unique approach by combining food and exercise tracking with psychological principles to motivate behavioral change, potentially enhancing long-term weight management. These innovative approaches differ from traditional obesity treatments like lifestyle counseling or medication, offering new pathways to support individuals in maintaining their weight loss achievements.

What evidence suggests that this trial's treatments could be effective for preventing weight regain in obesity?

This trial will explore various strategies to prevent weight regain in obesity. Research has shown that GLP-1 receptor agonists, not included in this trial, can aid in weight loss, but many individuals regain weight after discontinuation. Studies have found significant weight regain within a year of stopping, raising concerns about the long-term effectiveness of these treatments.

In this trial, participants may receive medically tailored meals, which have been proven to improve health, especially for those at nutritional risk, and may help maintain weight loss. Another group will use the Noom app, which focuses on habit change and progress tracking, and has helped many people maintain weight loss. Specifically, about 75% of Noom users maintained at least a 5% weight loss after one year.

These alternative methods offer promising ways to help maintain weight after initial loss. ^{1 5 6 7 8}

Who Is on the Research Team?

Kelseanna Hollis-Hansen, PhD, MPH

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I stopped taking GLP-1 receptor agonist less than 30 days ago.

Willing to participate

I have lost more than 10% of my weight using a GLP-1 receptor agonist.

Exclusion Criteria

Participation in a study or program involving medically tailored meals or Noom® within the past 12-months

Major psychiatric illness or substance misuse that could impair ability to participate

I can eat solid foods and have no conditions that cause weight loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either medically tailored meals, a Noom® subscription, or usual care for four months after GLP-1 Receptor Agonist cessation

16 weeks

Follow-up

Participants are monitored for adherence, satisfaction, and weight maintenance after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GLP-1 Receptor Agonist
• Medically tailored meals
• Noom®

Trial Overview

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.

How Is the Trial Designed?

Group I: Noom® Experimental Treatment 2 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 meals Experimental Treatment 2 Interventions

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

Group III: Usual care Placebo Group 1 Intervention

Participants will receive usual care from their provider.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

UT Southwestern Nutrition Obesity Research Center

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a study of 52 healthy obese individuals, the GLP-1 receptor agonist liraglutide helped maintain a 12% weight loss over 52 weeks by significantly reducing the increase in soluble leptin receptors and preserving free leptin levels, which are important for appetite regulation.

Participants receiving liraglutide experienced greater weight maintenance and improved glucose tolerance compared to the control group, suggesting that GLP-1RAs can effectively support weight loss maintenance and potentially prevent pre-diabetes in obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment with a GLP-1 receptor agonist diminishes the decrease in free plasma leptin during maintenance of weight loss. Iepsen, EW., Lundgren, J., Dirksen, C., et al.[2022]

In a study involving 10 healthy overweight males, the GLP-1 receptor agonist exenatide was found to increase heart rate by an average of 6.8 beats per minute and systolic blood pressure by 9.8 mmHg, indicating a significant cardiovascular effect.

The increase in heart rate and blood pressure was linked to sympathetic nervous system activation rather than a reflex response to vasodilation, suggesting that the mechanism behind these changes is related to increased sympathetic activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide acutely increases heart rate in parallel with augmented sympathetic nervous system activation in healthy overweight males. Smits, MM., Muskiet, MH., Tonneijck, L., et al.[2022]

Chronic administration of the GLP-1 receptor agonist semaglutide (SEMA) in rats led to reduced food intake and body weight, indicating its efficacy in weight management, similar to effects seen in humans with obesity.

Interestingly, while SEMA-treated rats consumed more sucrose at lower concentrations compared to controls, their overall energy intake became similar to that of control rats, suggesting that SEMA's impact on food intake may vary depending on the type of caloric source available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic Semaglutide Treatment in Rats Leads to Daily Excessive Concentration-Dependent Sucrose Intake. Cawthon, CR., Blonde, GD., Nisi, AV., et al.[2023]

In a study of 44 non-diabetic patients who experienced weight regain or insufficient weight loss after bariatric surgery, adjunct treatment with the GLP-1 receptor agonist semaglutide resulted in significant weight loss of -6.0% after 3 months and -10.3% after 6 months, indicating its efficacy in managing post-bariatric weight issues.

The study suggests that semaglutide could be a beneficial treatment option for patients struggling with weight regain after surgery, but further research through prospective randomized controlled trials is needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Semaglutide Once-Weekly in Patients Without Type 2 Diabetes with Weight Regain or Insufficient Weight Loss After Bariatric Surgery-a Retrospective Analysis. Lautenbach, A., Wernecke, M., Huber, TB., et al.[2022]

In a phase II trial involving 297 adults with obesity, efpeglenatide significantly reduced body weight compared to placebo, with reductions ranging from -6.3 kg to -7.2 kg after 20 weeks of treatment.

Efpeglenatide also improved blood sugar levels and lipid profiles, showing it is effective for weight management and metabolic health in adults without diabetes, while being generally well tolerated despite some gastrointestinal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body weight management and safety with efpeglenatide in adults without diabetes: A phase II randomized study. Pratley, RE., Kang, J., Trautmann, ME., et al.[2021]

GLP-1 receptor agonists, while raising safety concerns about potential links to pancreatitis and tumors, have not shown a significant association with these risks in clinical studies, which often have biases.

Regulatory bodies like the FDA and EMA suggest that current safety concerns should not hinder the use of GLP-1Rx agonists, as they provide important benefits for many patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential side effects to GLP-1 agonists: understanding their safety and tolerability. Consoli, A., Formoso, G.[2018]

GLP-1 receptor (GLP-1R) agonists have shown promising results in treating obesity, demonstrating greater effectiveness in clinical trials and animal studies compared to other anti-obesity drugs.

While many anti-obesity medications face safety and effectiveness concerns, GLP-1R agonists are highlighted as a safer and more compliant option for weight loss, potentially reducing obesity-related health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLP-1 receptor agonists for the treatment of obesity: Role as a promising approach. Wang, JY., Wang, QW., Yang, XY., et al.[2023]

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are effective for weight loss in overweight or obese patients with type 2 diabetes, showing significant reductions in weight compared to placebo across multiple studies involving 27 trials.

There was no significant difference in weight loss efficacy among the different GLP-1 RAs tested, indicating that they are similarly effective options for managing weight in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Glucagon-Like Peptide 1 Receptor Agonists on Weight Loss in Type 2 Diabetes: A Systematic Review and Mixed Treatment Comparison Meta-Analysis. Potts, JE., Gray, LJ., Brady, EM., et al.[2022]

GLP-1 receptor agonists, like liraglutide (Saxenda), have been shown to effectively promote weight loss in both patients with and without type 2 diabetes, making them a valuable option for long-term weight management.

These medications work by enhancing feelings of fullness and slowing down gastric emptying, and they generally have a favorable safety profile, with mild gastrointestinal symptoms being the most common side effects reported in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of glucagon-like peptide 1 receptor agonists in management of obesity. Isaacs, D., Prasad-Reddy, L., Srivastava, SB.[2022]

GLP-1 receptor agonists, such as exenatide and liraglutide, resulted in significant weight loss in overweight or obese patients, with an average loss of 2.9 kg compared to control groups, based on a systematic review of 25 trials involving 6411 participants.

These medications not only aided in weight loss but also improved blood pressure and cholesterol levels without causing hypoglycemia, although they were associated with some gastrointestinal side effects like nausea and diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. Vilsbøll, T., Christensen, M., Junker, AE., et al.[2022]

GLP-1 receptor agonists are effective for treating type 2 diabetes and obesity, showing significant improvements in blood sugar control and weight loss, but they still fall short compared to the results of bariatric surgery.

Emerging co-agonist therapies, such as tirzepatide and combinations with amylin, show promise for enhanced efficacy, suggesting that future treatments could outperform current GLP-1R agonists in managing metabolic disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 receptor co-agonists for treating metabolic disease. Baggio, LL., Drucker, DJ.[2021]

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