GLP-1 Lifestyle Program for Obesity
(PRESERVE GLP-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will test whether adding a lifestyle program to GLP-1 medication treatment can help preserve muscle, reduce cardiovascular risk, and improve quality of life in adults with overweight or obesity. About 670 adults who are starting a GLP-1 medication for weight loss will be enrolled. Participants will be randomly assigned to either a 6-month YMCA lifestyle program that includes resistance exercise and nutrition support, or to enhanced usual care with monthly health education workshops. Study assessments will occur at baseline, 6 months, and 12 months. The main outcome is the change in appendicular lean tissue mass measured by DXA at 6 months. Other outcomes include cardiovascular risk, quality of life, bone density, total lean mass, weight loss, dietary intake, and physical activity.
Are You a Good Fit for This Trial?
This trial is for adults with overweight or obesity who are starting a GLP-1 medication for weight loss. Participants should be able to join exercise and nutrition programs and attend regular study visits.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced Usual Care Health Education
- GLP-1 Lifestyle Management Program
Trial Overview
The study compares two approaches: one group gets a YMCA lifestyle program with resistance exercise and nutrition support, while the other receives monthly health education workshops. Both groups use GLP-1 medications. The main goal is to see which approach better preserves muscle over 6 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive a 6-month First Coast YMCA Lifestyle Management Program tailored for adults using GLP-1 receptor agonists. The program includes supervised progressive resistance training 2 days per week and nutrition counseling 1 day per week. Nutrition counseling includes individualized protein goals and daily fruit, vegetable, and water targets.
Participants will attend a monthly health education workshop for 6 months and continue to follow guidance from their GLP-1 prescribing clinician. Health education topics may include navigating the health care system, safe travel, preventive services and screenings, reliable health information, and caregiving. Specific diet or exercise prescriptions will not be provided by the study in this group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
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