An interventional study of GLP-1 Lifestyle Management Program and Enhanced Usual Care Health Education in Obesity & Overweight, sponsored by University of Florida. Not yet recruiting at 1 site in United States. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of Florida · Not applicable, Interventional, and Prevention
Among 37 studies in Obesity by University of Florida — 5 open to participants now, 6 under way, none of them phase 3. Obesity · University of Florida.
Among the 37 studies in Obesity by University of Florida, this one is the 3rd largest by planned enrollment of the 34 interventional ones that give a count, is the only one that started in 2027, is one of 29 with no phase, and was the 37th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →5 of the 37 studies in Obesity by University of Florida are open now, in 1 country. Recruiting first, the newest first:
University of Florida · Sites in United States
Ages 25+ · Women only · Healthy volunteers
University of Florida · Sites in United States
Ages 18+
University of Florida · Sites in United States
Ages 18+
University of Florida · Sites in United States
Ages 13–17
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 30 Years to 79 Years · all sexes · no healthy volunteers.
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37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 4 1
First in 2003; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 670 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 55 across the 34 interventional studies, 392 across the 3 observational. Of the 31 that completed or were terminated, 13 (42%) have results posted.
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University of Florida is the lead sponsor of 1,288 studies on the registry; 200 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
2 of the studies in Obesity by University of Florida that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05561595University of FloridaTransdiagnostic Intervention to Reduce Internalized Health-Related Stigma | 2026-12-31 |
| NCT07714759University of FloridaA Study Comparing Continuous Glucose Monitoring Augmented Nutritional Counseling and Standard of Care Treatment Strategies in a Three-Month Nutrition Intervention | 2027-08 |
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Among the 37 studies in Obesity by University of Florida, from their registry updates:
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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 participate in a 6-month First Coast YMCA Lifestyle Management Program that includes supervised resistance training 2 days per week and nutrition counseling 1 day per week. The enhanced usual care group will attend a monthly health education workshop and continue to follow guidance from their prescribing clinician. Assessments will be completed at baseline, 6 months, and 12 months. The primary outcome is change in appendicular lean tissue mass at 6 months, measured by dual-energy X-ray absorptiometry (DXA). Secondary outcomes include atherosclerotic cardiovascular disease risk, self-reported quality of life, bone density, total lean mass, weight loss, dietary intake, and physical activity and sedentary behavior.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: GLP-1 Lifestyle Management Program
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.
Behavioral: Enhanced Usual Care Health Education
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.
Change in Appendicular Lean Tissue Mass
Change in appendicular lean tissue mass measured by dual-energy X-ray absorptiometry (DXA), expressed in kilograms (kg).
Time frame: Baseline to 6 months
Change in Atherosclerotic Cardiovascular Disease (ASCVD) Risk
Change in estimated 10-year atherosclerotic cardiovascular disease risk calculated using the American Heart Association PREVENT risk equations. Clinical and laboratory variables are combined to generate a single estimated risk percentage (0-100%), with higher percentages indicating greater cardiovascular risk.
Time frame: Baseline to 6 months and 12 months
Change in SF-36v2 Physical Component Summary Score
Change in the Physical Component Summary (PCS) score of the 36-Item Short Form Health Survey, Version 2 (SF-36v2). Higher scores indicate better physical health-related quality of life. The PCS is calculated using norm-based scoring, standardized to a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate better physical health-related quality of life.
Time frame: Baseline to 6 months and 12 months
Change in SF-36v2 Mental Component Summary Score
Change in the Mental Component Summary (MCS) score of the 36-Item Short Form Health Survey, Version 2 (SF-36v2). Higher scores indicate better mental health-related quality of life. The MCS is calculated using norm-based scoring, standardized to a mean of 50 and a standard deviation of 10 in the reference population. Higher scores indicate better mental health-related quality of life.
Time frame: Baseline to 6 months and 12 months
Change in Total Hip Bone Mineral Density
Change in total hip bone mineral density measured by dual-energy X-ray absorptiometry (DXA), expressed in grams per square centimeter (g/cm²).
Time frame: Baseline to 6 months and 12 months
Change in Lumbar Spine Bone Mineral Density
Change in lumbar bone mineral density measured by dual-energy X-ray absorptiometry (DXA), expressed in grams per square centimeter (g/cm²).
Time frame: Baseline to 6 months and 12 months
Change in Body Weight
Change in body weight measured using a calibrated scale, expressed in kilograms (kg).
Time frame: Baseline to 6 months and 12 months
Change in Total Lean Mass
Change in total lean mass measured by whole-body dual-energy X-ray absorptiometry (DXA), expressed in kilograms (kg).
Time frame: Baseline to 6 months and 12 months
Plan to share: Undecided — This is a discussion item within our study team at the current time.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Nov 2031, 58 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 58 months is above that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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