Muscle and Movement With Anti-Obesity Medications
ConditionObesity and Overweight
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
The goal of this clinical trial is to learn about changes in body composition related to obesity medication use, and whether aerobic or resistance exercise training will impact these body composition changes. It will also provide information about whether aerobic or resistance exercise training 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 body composition (fat mass, lean mass, muscle mass, and bone content) between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in body weight and BMI between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in cardiorespiratory fitness between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in how much physical activity is completed between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in physical function between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in muscle strength between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in resting blood pressure between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in food intake between the standard medical care and the exercise conditions (aerobic training and resistance training)? * Is there a difference in the change in health-related quality of life between the standard medical care and the exercise conditions (aerobic training and resistance training)?
Participants will:
* Participate in an intervention for a period of 6 months that involves being assigned to a no exercise/standard medical care condition, or a supervised exercise condition (aerobic training or resistance training). * Visit the clinical before starting the study and at 6 months to complete study measurements of their body composition and other measurements to monitor their progress. * Complete a brief monitoring session at weeks 6, 12, and 18 across the 6 months. * Complete supervised exercise sessions at the research center 3x per week for 6 months (Participants in the exercise groups only: aerobic training or resistance training).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both males and females of all race/ethnic groups are eligible for participation in this study.
Age: Randomized Study: Adults that are 18 to <60 years of age. Observational Study: Adults that are >60 years of age.
Newly prescribed AOM (semaglutide, tirzepatide) for the treatment of obesity, 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 this 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. Enrollment will not be limited based on an upper BMI level provided that the participant meets the other eligibility requirements. However, weight or size limits of the dual-energy x-ray absorptiometry (DXA) system that is used to assess body composition must not be exceeded.
Disqualifiers
Type 2 diabetes.
Report moderate-to-vigorous exercise for >60 min/week, and >1 day 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Medical Care (SMC)
Other interventionStandard Medical Care will continue to receive their regular standard clinical care during the 6-month intervention period of this study.
Monitoring Contacts
BehavioralParticipants will receive contacts with the research staff at weeks 6, 12, and 18.
Aerobic Training
BehavioralAerobic Training will be supervised exercise. It 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, alternative forms of cardiovascular exercise (upright cycling, elliptical, etc.) are allowed to accommodate any physical limitations that may be present for a participant. Heart rate will be monitored throughout these exercise sessions.
Resistance Training
BehavioralResistance Training will be supervised exercise. It will occur 3 days per week and includes 8 exercises performed in a prespecified order. Week 1-2 sessions focus on familiarization to acclimate the participant to the equipment, proper form, to establish initial weight (load) for training, and with performing multiple sets per day. For Weeks 3-8, participants will engage in 2 sets per exercise with the weight adjusted to elicit muscle fatigue in 8-12 repetitions per set. This progresses to 3 sets per exercise from Week 9 until the end of the intervention period. When 12 repetitions for a specific exercise can be achieved, the resistance will increase for that exercise at the next session. There is a 90 second rest period between each set of an exercise. Heart rate will be monitored throughout these exercise sessions.
Nutrition Education
Other interventionA single counseling session to discuss the dietary recommendations when taking an obesity medication.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Standard Medical CareActive comparator 3 interventions
Group B: Standard Medical Care plus Aerobic TrainingExperimental treatment 4 interventions
Group C: Standard Medical Care plus Resistance TrainingExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Lean Body Mass
Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame
0 and 6 monthsSecondary outcomes
1
Body Fat Mass
Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame
0 and 6 months2
Percent Body Fat
Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Time frame
0 and 6 months3
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
Time frame
0 and 6 months; 6, 12, 18 weeks4
Body Height
Body height will be assessed in duplicate using a wall mounted stadiometer to the nearest 0.1 cm.
Time frame
0 and 6 months; 6, 12, and 18 weeksOther outcomes
1
Demographic Characteristics
Demographic Characteristics will be assessed using a survey.
Time frame
0 months2
Lifestyle and Health History
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 months3
Medication History
A questionnaire developed specifically for this study will be used to assessment medication history. 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; 6, 12, and 18 weeks4
Adverse and Serious Adverse Events
Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
Time frame
0 and 6 months; 6, 12, and 18 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov