Dietary Counseling + Exercise for Obesity

AV
BL
Overseen ByBrad Lambert
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: William Marsh Rice University
Must be taking: GLP-1 agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether combining exercise with personalized dietary advice can maintain muscle and bone health in individuals with obesity using GLP-1 medications like semaglutide, which is used for weight management. The study aims to determine if these lifestyle changes can prevent muscle and bone mass loss during weight loss with the medication. Individuals with a BMI over 30, a higher body fat percentage, and eligibility for GLP-1 therapy, but without Type II diabetes, may be suitable candidates for this trial. As a Phase 4 trial, the research focuses on understanding how this FDA-approved treatment can benefit a broader range of patients.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it focuses on people already eligible for GLP-1 therapy, so you may continue with those medications.

What is the safety track record for these treatments?

Research has shown that semaglutide, a type of medication, is generally well-tolerated. Studies have demonstrated that semaglutide leads to significant weight loss, making it a popular choice for treating obesity. Most users report mild side effects, such as nausea, vomiting, or diarrhea, which often improve over time.

One study found that individuals using semaglutide lost about 12% of their body weight. While this result is impressive, some individuals may also lose muscle and bone mass, which is concerning because muscle and bone are vital for overall health and physical function.

Semaglutide is approved by the FDA for managing other conditions, indicating its safety when used under a doctor's supervision. However, healthcare professionals should monitor its use to manage any potential side effects effectively.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about combining semaglutide with exercise and dietary counseling for obesity because it offers a more comprehensive approach than using the drug alone. While semaglutide, a GLP-1 receptor agonist, is already a standard treatment that helps regulate appetite and blood sugar, adding structured exercise and personalized dietary guidance could enhance weight loss and improve overall health. This combination aims to tackle obesity from multiple angles, potentially leading to better long-term outcomes and healthier lifestyle changes.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that semaglutide, a type of medication, is highly effective for weight loss in people with obesity. Studies have found that semaglutide can lead to significant weight loss, with some individuals losing over 10% of their body weight in just a few months. In this trial, participants in the treatment arm will receive semaglutide along with a structured exercise program and individualized dietary counseling. This combination can enhance the effects of semaglutide. Regular exercise and healthy eating, when combined with semaglutide, help maintain muscle and bone strength, which is crucial for overall health. Evidence suggests that this approach not only boosts weight loss but also improves strength and fitness. By incorporating exercise and good nutrition, patients can achieve better health outcomes while reducing potential side effects.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 40-55 with obesity (BMI over 30 and high body fat), who are eligible for GLP-1 medication but do not have type II diabetes. Participants should also have more belly than hip fat.

Inclusion Criteria

I am between 40 and 55 years old.
* Body Mass Index (BMI) greater than 30
My body fat is over 30% (male) or 40% (female).
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GLP-1 therapy with or without a 12-week structured exercise program and individualized dietary counseling

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dietary Counseling
  • Exercise
  • Semaglutide

Trial Overview

The study tests if a 12-week program of exercise and personalized nutrition counseling can help prevent muscle and bone loss in obese adults taking the weight-loss drug semaglutide (a GLP-1 medication).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm: GLP-1 Therapy + Exercise and Dietary CounselingExperimental Treatment2 Interventions
Group II: Control Arm: GLP-1 Therapy AloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Marsh Rice University

Lead Sponsor

Trials
50
Recruited
28,400+

The Methodist Hospital Research Institute

Collaborator

Trials
299
Recruited
82,500+

Citations

GLP-1 agonists and exercise: the future of lifestyle prioritization

Direct comparisons reveal that GLP-1RAs generally produce greater short-term weight loss than exercise alone, but exercise is superior for ...

Nutritional priorities to support GLP-1 therapy for obesity

Individuals using GLP-1s to treat obesity experience significant reductions in appetite and energy intake, with observed caloric reductions of ...

Once-Weekly Semaglutide in Adults with Overweight or ...

Analyses from the DXA substudy suggested that semaglutide led to greater reduction in fat mass than lean body mass, a finding consistent with ...

Comparison of semaglutide and lifestyle counseling for ...

Main Outcome and Measures The primary outcome was incidence of 10% or greater reduction in weight from baseline. Results There were 3,927 ...

Efficacy of lifestyle modification combined with GLP-1 ...

Lifestyle modification combined with GLP-1RAs results in a significant mean weight loss of 7.13 kg compared with control groups (MD: −7.13 kg, 95% CI: −9.02, − ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41211586/

Efficacy and Safety of Glucagon-Like Peptide-1 Receptor ...

Conclusions: GLP-1 RAs, especially semaglutide and tirzepatide, are effective for weight management. Liraglutide may remain a viable, cost- ...

Semaglutide and Cardiovascular Outcomes in Obesity ...

The mean change in body weight over the 104 weeks after randomization was –9.39% with semaglutide and –0.88% with placebo (estimated treatment ...

Review Comparative safety and side effects of semaglutide ...

A case series reported that Tirzepatide has the potential to trigger hypoglycemic ketoacidosis in non-diabetic individuals with obesity when employed for weight ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39761578/

Efficacy and Safety of Glucagon-Like Peptide-1 Receptor ...

Compared with placebo, tirzepatide (15 mg once weekly) resulted in weight loss of up to 17.8% (95% CI, 16.3% to 19.3%) after 72 weeks of therapy ...

GLP-1 Agonists: The Latest Obesity Long-Term Use Data

The study results showed that treatment with once-weekly subcutaneous semaglutide was associated with clinically impactful and sustained weight ...