Obesity & OverweightM3-ENCT07698145
Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise
A study testing Standard Medical Care with an Obesity Management Medication, Cardiovascular Exercise Training and Resistance Exercise Training in people with Obesity & Overweight, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether adding either cardiovascular exercise or resistance exercise to pharmacotherapy treatment for obesity improves the retention of lean mass compared to pharmacotherapy alone in adults with overweight or obesity who are prescribed pharmacotherapy for obesity treatment… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Standard Medical Care with an Obesity Management Medication, Cardiovascular Exercise Training and Resistance Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both males and females of all race/ethnic groups are eligible for participation in this study.
- 18 to <65 years of age.
- Newly prescribed FDA-approved obesity manage medication that can include Tirzepatide, Semaglutide, or up to 4 additional next-generation obesity management medications (will receive DSMB approval prior to inclusion), approval for treatment (pharmacy, insurance, etc.), and the participant agreeing to start this treatment and continue treatment for at least 6 months (the participant will be recruited prior to this medication being initiated).
- Body mass index (BMI) of >=27.0 kg/m2 with at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) provided it does not compromise the ability to safely complete the screening or outcome measures or to engage in the prescribed exercise interventions), or >=30 kg/m2 without weight-related complications. We will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, the participant will be excluded if they exceed the weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition or the MRI that is used to assess muscle quality.
- Ability to provide informed consent prior to participation in this study.
- Clearance from the study physician for meeting all eligibility criteria for this study.
Who cannot join
- Type 2 diabetes.
- Report moderate-to-vigorous exercise for >60 min/week, and >1 day/week of structured cardiovascular or resistance exercise over the past 3 months.
- Report sustained weight loss of >=3% in the past 3 months.
- History of metabolic/bariatric surgery.
- Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.
- Report a current medical condition or treatment for a medical condition that could affect body weight or contradict engagement in any aspect of the outcome measures or interventions.
Show all 14Show fewer
- History of muscle conditions that may impact the quality of muscle or response to the study interventions (e.g., myopathy, muscular dystrophy, rhabdomyolysis, etc.).
- Contraindications to MRI (e.g., metal implants that are not MRI safe, etc.). NOTE: Participants who are otherwise eligible other than being contraindicated for the MRI scan will be eligible and the MRI scan will not be performed as a research procedure.
- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction or history of cardiomyopathy, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).
- Resting systolic blood pressure of >=160 mmHg or resting diastolic blood pressure of >=100 mmHg. If medicated for blood pressure control, the medication dose needs to be stable for >=6 months.
- Eating disorders that would contraindicate weight loss or physical activity.
- Alcohol or substance abuse.
- Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
John M. Jakicic, PhD, 913-588-9078, jjakicic@kumc.edu
Renee J. Rogers, PhD, 913-588-8580, rrogers10@kumc.edu
About this study
The goal of this clinical trial is to learn whether adding either cardiovascular exercise or resistance exercise to pharmacotherapy treatment for obesity improves the retention of lean mass compared to pharmacotherapy alone in adults with overweight or obesity who are prescribed pharmacotherapy for obesity treatment by their personal physician. It will also provide information about whether either form of exercise added to pharmacotherapy for obesity treatment has additional benefits on other health and fitness measurements. The main questions it aims to answer are:
- Is there a difference in the change in total lean body mass between pharmacotherapy alone and either pharmacotherapy plus cardiovascular exercise or pharmacotherapy plus resistance exercise?
- Is there a difference in the change in muscle mass between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in muscle quality between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in body weight between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in body composition (fat mass, fat mass distribution) between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in cardiorespiratory fitness between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in muscle strength between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in physical function between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in bone mineral density between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in bone biomarkers between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in resting blood pressure between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in energy intake between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in physical activity between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there an effect of sex, race/ethnicity, age, menopausal status, obesity management medication type, or other demographic characteristics on the outcomes that are being measured.
- What is the extent to which the retention of lean body mass or muscle mass mediates the effect of exercise on weight changes.
Read more
Participants will:
- Initiate and continue throughout the study period an eligible obesity management medication that is prescribed by their healthcare provider, and to report their adherence to this medication to the investigators.
- Participant in this study for a period of 6-8 months to complete outcome assessments that occur at baseline and at the conclusion of 6 months of the intervention period, and monitoring visits that occur at weeks 3, 6, 9, 12, 15, 18, and 21.
- If attend 3 supervised exercise sessions per week if assigned to either the cardiovascular exercise intervention or the resistance training intervention for a period of 24 weeks.
- Conditions
- Obesity & Overweight
- Being tested
- Standard Medical Care with an Obesity Management Medication, Cardiovascular Exercise Training, Resistance Exercise Training, Nutrition Counseling
- Keywords
- overweight, obesity, exercise, physical activity, pharmacotherapy, body composition
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical Care with an Obesity Management MedicationOther
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Cardiovascular Exercise TrainingBehavioural
Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.
Resistance Exercise TrainingBehavioural
Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.
Nutrition CounselingBehavioural
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care with an Obesity Management Medication | Experimental | Participants will receive standard medical care from their personal physician related to their obesity management medication for a period of 6 months. Progression of this medication will be monitored as part of the participation in this study. Participants will undergo screening and baseline assessments prior to initiating the use of the medication and after a period of 6 months. Upon randomization, participants will receive a "Nutrition 101" session where dietary considerations while taking this medication will be discussed. We will also have a brief contact (weeks 3, 6, 9, 12, 15, 18, and 21) with the participant to monitor changes in weight, blood pressure, health status, and medication adherence and use (including the dose of the obesity management medication that they have been prescribed). Participants will be instructed to maintain their current level of physical activity throughout the 6-month study period. Receives: Other: Standard Medical Care with an Obesity Management Medication; Behavioral: Nutrition Counseling |
| Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training | Experimental | Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised cardiovascular exercise training. This will occur on 3 days per week and will progress to 50 minutes per session (150 minutes per week). The intensity of the exercise will progress from 60%±5% to 70%±5% of age-predicted maximal heart rate (if taking beta-blocker medication intensity will progress from a Rating of Perceived Exertion of 11-13 to 12-14 based on the 6-20 Borg scale). While walking will be the preferred mode of exercise, we will allow for alternative forms of cardiovascular exercise (upright or recumbent cycling, elliptical, etc.) to accommodate any physical limitations that may be present for a participant. Heart rate will be monitored throughout these exercise sessions. Receives: Other: Standard Medical Care with an Obesity Management Medication; Behavioral: Cardiovascular Exercise Training; Behavioral: Nutrition Counseling |
| Standard Care with an Obesity Management Medication Plus Resistance Exercise Training | Experimental | Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised resistance exercise training. This will occur 3 days per week and involve 9 different exercises. Each exercise will progress to 3 sets with a rest period of 60 to 90 seconds between each set. Warm-up sets will include 10 repetitions, and all remaining sets will perform repetitions until volitional fatigue. Heart rate will be monitored throughout these exercise sessions. Receives: Other: Standard Medical Care with an Obesity Management Medication; Behavioral: Resistance Exercise Training; Behavioral: Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Lean Body Mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Secondary outcomes (23)
Muscle Mass
Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method.
Measured: 0 and 6 months
Muscle Quality
Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh.
Measured: 0 and 6 months
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
Measured: 0 months, week 6, week 12, week 18, 6 months
Body Mass Index
Measurements of weight and height will be used to compute BMI (kg/m2).
Measured: 0 months, week 6, week 12, week 18, 6 months
Percent body fat
Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Body Fat Mass
Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Bone mineral content
Bone mineral content (grams) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Bone mineral density
Bone mineral density (g/cm2) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA).
Measured: 0 and 6 months
Bone Biomarkers
Bone biomarkers will be assessed from blood samples collected using venipuncture.
Measured: 0 and 6 months
Waist Circumference
Circumference measures of the waist will be taken horizontally at both the iliac crest and the umbilicus.
Measured: 0 and 6 months
Hip Circumference
Circumference measures of the hip will be taken horizontally at the widest observed portion of the buttocks.
Measured: 0 and 6 months
Cardiorespiratory Fitness
Cardiorespiratory fitness will be represented as milliliters of oxygen consumed per kilogram of body weight per minute (ml/kg/min) measured with a metabolic cart during a submaximal graded exercise test that is terminated when the participant achieves 85% of age-predicted maximal heart rate or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale.
Measured: 0 and 6 months
Cardiorespiratory Fitness
Cardiorespiratory fitness will be represented as total liters of oxygen consumed per minute (L/min) measured with a metabolic cart during a submaximal graded exercise test that is terminated when the participant achieves 85% of age-predicted maximal heart rate or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale.
Measured: 0 and 6 months
Cardiorespiratory Fitness
Cardiorespiratory fitness will be the duration measured in minutes to achieve 85% of age-predicted maximal heart rate during a submaximal graded exercise test performed on a treadmill or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale.
Measured: 0 and 6 months
Muscle Strength
Muscular strength will be measured from an isometric leg extension performed on a dynamometer.
Measured: 0 and 6 months
Physical Function
Physical function will be measured using the Short Physical Performance Protocol (SPPB) that includes balance, gait speed, and chair stands).
Measured: 0 and 6 months
Muscle Power
Muscle Power is measured using the Margaria Power Stair Climb Task that requires the participant to walk up a standardized flight of stair, with the score being the time it takes to walk from the 3rd step to the 9th step. A faster time at a given body mass indicates a greater level of muscle power.
Measured: 0 and 6 months
Health-Related Quality of Life
Health-related quality of life is assessed with a standardized questionnaire. This questionnaire consists of 8 scales (physical functioning, role limitations caused by health problems, role limitation caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, general health perceptions) with each scale score between 0-100. This also consists of 2 subscales (physical and mental health) with these being scored as the average of the scores from the scales that are factored into each measure. This also provides an overall score, which is the average of the scores for each of the 8 scales. A higher score on a scale or subscale indicates a higher health-related quality of life.
Measured: 0 and 6 months
Energy Intake (Dietary Intake)
Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using the Diet History Questionnaire (DHQ) developed by NCI. A higher score represents more calories eaten.
Measured: 0 months, week 6, week 12, week 18, 6 months
Energy Intake (Dietary Intake)
Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using a 3-day dietary recall (2 weekdays and 1 weekend day). A higher score represents more calories eaten.
Measured: 0 months, week 6, week 12, week 18, 6 months
Physical Activity
Physical activity will be measured using the Physical Activity and Exercise Questionnaire. A higher score represents more physical activity expressed as minutes per week or calories of energy expenditure per week.
Measured: 0 and 6 months
Physical Activity
Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ). A higher score represents more physical activity expressed as minutes per week or calories of energy expenditure per week.
Measured: 0 and 6 months
Physical Activity
Physical activity will be measured Garmin wrist worn activity tracker that will be provided to each participant to wear throughout the entire 6 month intervention period. A higher score represents more physical activity.
Measured: 0 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M. Jakicic, PhD, University of Kansas Medical Center
- Investigators
- John M. Jakicic, PhD, Principal investigator, University of Kansas Medical CenterRenee J. Rogers, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698145
- Sponsor's protocol ID
- STUDY00161746
- Other IDs
- R01DK141779-01A1
- Acronym
- M3-E
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The summary data for each of the study outcomes and other additional demographic characteristics will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise
- ClinicalTrials.gov ID
- NCT07698145
- Acronym / sponsor ID
- M3-E / STUDY00161746
- Conditions
- Obesity & Overweight
- Keywords
- overweight, obesity, exercise, physical activity, pharmacotherapy, body composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether adding either cardiovascular exercise or resistance exercise to pharmacotherapy treatment for obesity improves the retention of lean mass compared to pharmacotherapy alone in adults with overweight or obesity who are prescribed pharmacotherapy for obesity treatment by their personal physician. It will also provide information about whether either form of exercise added to pharmacotherapy for obesity treatment has additional benefits on other health and fitness measurements. The main questions it aims to answer are:
- Is there a difference in the change in total lean body mass between pharmacotherapy alone and either pharmacotherapy plus cardiovascular exercise or pharmacotherapy plus resistance exercise?
- Is there a difference in the change in muscle mass between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in muscle quality between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in body weight between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in body composition (fat mass, fat mass distribution) between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in cardiorespiratory fitness between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in muscle strength between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in physical function between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in bone mineral density between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in bone biomarkers between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in resting blood pressure between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in energy intake between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there a difference in the change in physical activity between the intervention conditions (pharmacotherapy alone, pharmacotherapy plus cardiovascular exercise, pharmacotherapy plus resistance exercise)?
- Is there an effect of sex, race/ethnicity, age, menopausal status, obesity management medication type, or other demographic characteristics on the outcomes that are being measured.
- What is the extent to which the retention of lean body mass or muscle mass mediates the effect of exercise on weight changes.
Participants will:
- Initiate and continue throughout the study period an eligible obesity management medication that is prescribed by their healthcare provider, and to report their adherence to this medication to the investigators.
- Participant in this study for a period of 6-8 months to complete outcome assessments that occur at baseline and at the conclusion of 6 months of the intervention period, and monitoring visits that occur at weeks 3, 6, 9, 12, 15, 18, and 21.
- If attend 3 supervised exercise sessions per week if assigned to either the cardiovascular exercise intervention or the resistance training intervention for a period of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care with an Obesity Management Medication | Experimental | Other: Standard Medical Care with an Obesity Management Medication, Behavioral: Nutrition CounselingParticipants will receive standard medical care from their personal physician related to their obesity management medication for a period of 6 months. Progression of this medication will be monitored as part of the participation in this study. Participants will undergo screening and baseline assessments prior to initiating the use of the medication and after a period of 6 months. Upon randomization, participants will receive a "Nutrition 101" session where dietary considerations while taking this medication will be discussed. We will also have a brief contact (weeks 3, 6, 9, 12, 15, 18, and 21) with the participant to monitor changes in weight, blood pressure, health status, and medication adherence and use (including the dose of the obesity management medication that they have been prescribed). Participants will be instructed to maintain their current level of physical activity throughout the 6-month study period. |
| Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training | Experimental | Other: Standard Medical Care with an Obesity Management Medication, Behavioral: Cardiovascular Exercise Training, Behavioral: Nutrition CounselingParticipants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised cardiovascular exercise training. This will occur on 3 days per week and will progress to 50 minutes per session (150 minutes per week). The intensity of the exercise will progress from 60%±5% to 70%±5% of age-predicted maximal heart rate (if taking beta-blocker medication intensity will progress from a Rating of Perceived Exertion of 11-13 to 12-14 based on the 6-20 Borg scale). While walking will be the preferred mode of exercise, we will allow for alternative forms of cardiovascular exercise (upright or recumbent cycling, elliptical, etc.) to accommodate any physical limitations that may be present for a participant. Heart rate will be monitored throughout these exercise sessions. |
| Standard Care with an Obesity Management Medication Plus Resistance Exercise Training | Experimental | Other: Standard Medical Care with an Obesity Management Medication, Behavioral: Resistance Exercise Training, Behavioral: Nutrition CounselingParticipants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised resistance exercise training. This will occur 3 days per week and involve 9 different exercises. Each exercise will progress to 3 sets with a rest period of 60 to 90 seconds between each set. Warm-up sets will include 10 repetitions, and all remaining sets will perform repetitions until volitional fatigue. Heart rate will be monitored throughout these exercise sessions. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both males and females of all race/ethnic groups are eligible for participation in this study.
- 18 to <65 years of age.
- Newly prescribed FDA-approved obesity manage medication that can include Tirzepatide, Semaglutide, or up to 4 additional next-generation obesity management medications (will receive DSMB approval prior to inclusion), approval for treatment (pharmacy, insurance, etc.), and the participant agreeing to start this treatment and continue treatment for at least 6 months (the participant will be recruited prior to this medication being initiated).
- Body mass index (BMI) of >=27.0 kg/m2 with at least one weight-related complication (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) provided it does not compromise the ability to safely complete the screening or outcome measures or to engage in the prescribed exercise interventions), or >=30 kg/m2 without weight-related complications. We will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, the participant will be excluded if they exceed the weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition or the MRI that is used to assess muscle quality.
- Ability to provide informed consent prior to participation in this study.
Key exclusion criteria (14 listed)
- Type 2 diabetes.
- Report moderate-to-vigorous exercise for >60 min/week, and >1 day/week of structured cardiovascular or resistance exercise over the past 3 months.
- Report sustained weight loss of >=3% in the past 3 months.
- History of metabolic/bariatric surgery.
- Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Medical Care with an Obesity Management MedicationParticipant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication. | Other | Standard Care with an Obesity Management Medication, Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training, Standard Care with an Obesity Management Medication Plus Resistance Exercise Training |
| Cardiovascular Exercise TrainingParticipant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months. | Behavioural | Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training |
| Resistance Exercise TrainingParticipant will receive supervised resistance exercise training on 3 days per week for a period of 6 months. | Behavioural | Standard Care with an Obesity Management Medication Plus Resistance Exercise Training |
| Nutrition CounselingParticipant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study. | Behavioural | Standard Care with an Obesity Management Medication, Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training, Standard Care with an Obesity Management Medication Plus Resistance Exercise Training |
Primary outcome
Lean body mass
Time frame: 0 and 6 months
Lean Body Mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
23 secondary outcomes
Muscle Mass
Time frame: 0 and 6 months
Muscle Quality
Time frame: 0 and 6 months
Body Weight
Time frame: 0 months, week 6, week 12, week 18, 6 months
Body Mass Index
Time frame: 0 months, week 6, week 12, week 18, 6 months
Percent body fat
Time frame: 0 and 6 months
Body Fat Mass
Time frame: 0 and 6 months
Bone mineral content
Time frame: 0 and 6 months
Bone mineral density
Time frame: 0 and 6 months
Bone Biomarkers
Time frame: 0 and 6 months
Waist Circumference
Time frame: 0 and 6 months
Hip Circumference
Time frame: 0 and 6 months
Cardiorespiratory Fitness
Time frame: 0 and 6 months
Cardiorespiratory Fitness
Time frame: 0 and 6 months
Cardiorespiratory Fitness
Time frame: 0 and 6 months
Muscle Strength
Time frame: 0 and 6 months
Physical Function
Time frame: 0 and 6 months
Muscle Power
Time frame: 0 and 6 months
Health-Related Quality of Life
Time frame: 0 and 6 months
Energy Intake (Dietary Intake)
Time frame: 0 months, week 6, week 12, week 18, 6 months
Energy Intake (Dietary Intake)
Time frame: 0 months, week 6, week 12, week 18, 6 months
Physical Activity
Time frame: 0 and 6 months
Physical Activity
Time frame: 0 and 6 months
Physical Activity
Time frame: 0 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. The summary data for each of the study outcomes and other additional demographic characteristics will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John M. Jakicic, PhD principal investigator
University of Kansas Medical Center
Renee J. Rogers, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Medical Care with an Obesity Management Medication, Cardiovascular Exercise Training and Resistance Exercise Training in people with Obesity & Overweight, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M. Jakicic, PhD (913-588-9078, jjakicic@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean body mass (time frame: 0 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.