University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Location status: Recruiting
NCT Number: NCT07698145
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.
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication.
Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.
Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.
Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.
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).
Time frame: 0 and 6 months
Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method.
Time frame: 0 and 6 months
Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh.
Time frame: 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.
Time frame: 0 months, week 6, week 12, week 18, 6 months
Measurements of weight and height will be used to compute BMI (kg/m2).
Time frame: 0 and 6 months
Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame: 0 and 6 months
Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame: 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).
Time frame: 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).
Time frame: 0 and 6 months
Bone biomarkers will be assessed from blood samples collected using venipuncture.
Time frame: 0 and 6 months
Circumference measures of the waist will be taken horizontally at both the iliac crest and the umbilicus.
Time frame: 0 and 6 months
Circumference measures of the hip will be taken horizontally at the widest observed portion of the buttocks.
Time frame: 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.
Time frame: 0 and 6 months
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.
Time frame: 0 and 6 months
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.
Time frame: 0 and 6 months
Muscular strength will be measured from an isometric leg extension performed on a dynamometer.
Time frame: 0 and 6 months
Physical function will be measured using the Short Physical Performance Protocol (SPPB) that includes balance, gait speed, and chair stands).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 a 3-day dietary recall (2 weekdays and 1 weekend day). A higher score represents more calories eaten.
Time frame: 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.
Time frame: 0 and 6 months
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.
Time frame: 0 and 6 months
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.
Time frame: 0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
A questionnaire developed specifically for this study will be used to assess medication history and use of prescribed obesity management medications. The data collected include the type of medication, dose of medication, and frequency that the medication is taken, and what condition the medication is indicated to treat.
Time frame: 0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21
A questionnaire developed specifically for this study will be used to assess adherence to the prescribed obesity management medications. The data collected include the type of medication, dose of medication, and frequency that the medication is taken.
Time frame: 0 months
A questionnaire developed specifically for this study will be used to assessment demographic characteristics (age, sex, race, etc.).
Time frame: 0 months (prior to randomization)
A questionnaire developed specifically for this study that is conducted as an interview will be used to assess lifestyle and health factors to describe the sample for this study. The score is either "yes" or "no" identifying the presences of a lifestyle or health factor.
Time frame: 0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21 and at other times when reported by the participant
Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
Interested in participating?
Request InfoUniversity of Kansas Medical Center
Other
Acronym: M3-E
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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