Obesity & Overweight
Conditions
Keywords
overweight, obesity, exercise, physical activity, pharmacotherapy, body composition
Brief 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 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.
Interventions
OTHERStandard Medical Care with an Obesity Management Medication
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
BEHAVIORALCardiovascular Exercise Training
Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.
BEHAVIORALResistance Exercise Training
Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.
BEHAVIORALNutrition Counseling
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
Sponsors
University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lean body mass | 0 and 6 months | Lean Body Mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Mass | 0 and 6 months | Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method. |
| Muscle Quality | 0 and 6 months | Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh. |
| Body Weight | 0 months, week 6, week 12, week 18, 6 months | Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg. |
| Body Mass Index | 0 months, week 6, week 12, week 18, 6 months | Measurements of weight and height will be used to compute BMI (kg/m2). |
| Percent body fat | 0 and 6 months | Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). |
| Body Fat Mass | 0 and 6 months | Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). |
| Bone mineral content | 0 and 6 months | Bone mineral content (grams) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA). |
| Bone mineral density | 0 and 6 months | Bone mineral density (g/cm2) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA). |
| Bone Biomarkers | 0 and 6 months | Bone biomarkers will be assessed from blood samples collected using venipuncture. |
| Waist Circumference | 0 and 6 months | Circumference measures of the waist will be taken horizontally at both the iliac crest and the umbilicus. |
| Hip Circumference | 0 and 6 months | Circumference measures of the hip will be taken horizontally at the widest observed portion of the buttocks. |
| Cardiorespiratory Fitness | 0 and 6 months | 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. |
| Muscle Strength | 0 and 6 months | Muscular strength will be measured from an isometric leg extension performed on a dynamometer. |
| Physical Function | 0 and 6 months | Physical function will be measured using the Short Physical Performance Protocol (SPPB) that includes balance, gait speed, and chair stands). |
| Muscle Power | 0 and 6 months | 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. |
| Health-Related Quality of Life | 0 and 6 months | 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. |
| Energy Intake (Dietary Intake) | 0 months, week 6, week 12, week 18, 6 months | 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. |
| Physical Activity | 0 and 6 months | 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. |
Countries
United States
Contacts
CONTACTJohn M. Jakicic, PhD
CONTACTRenee J. Rogers, PhD
PRINCIPAL_INVESTIGATORJohn M. Jakicic, PhD
University of Kansas Medical Center
PRINCIPAL_INVESTIGATORRenee J. Rogers, PhD
University of Kansas Medical Center
Outcome results
None listed