University of Florida
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.
The study is a randomized controlled trial evaluating whether a lifestyle management program provided alongside GLP-1 receptor agonist therapy can preserve muscle mass and improve cardiovascular and quality-of-life outcomes. The study will enroll 670 adults ages 30-79 with obesity, or overweight with at least one weight-related comorbidity, who are beginning a GLP-1 receptor agonist approved for weight loss. Participants who have already started treatment must be randomized within 3 weeks of their first dose. Participants will be randomized to one of two groups. The intervention group will par…
Inclusion Criteria: * Age 30-79 years * Obesity (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity, such as hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease * Prescribed a GLP-1 receptor agonist approved for weight loss, including semaglutide, tirzepatide, or liraglutide * Able to enroll after prescription and before initiating GLP-1 therapy or, if already taking a GLP-1 receptor agonist, able to be randomized within 3 weeks of the first dose * Intends to continue the GLP-1 receptor agonist * English speaking Exclusion Cr…
Six-month lifestyle intervention consisting of supervised progressive resistance exercise twice weekly and nutrition counseling once weekly. The resistance program includes upper- and lower-body exercises with gradual progression in sets, repetitions, and intensity. Nutrition counseling focuses on adequate protein intake and daily fruit, vegetable, and hydration goals.
Monthly health education workshops for 6 months covering general health topics such as navigating the health care system, preventive services, safe travel, reliable health information, and caregiving. Participants are directed to their GLP-1 prescribing clinician for diet or exercise recommendations.
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