Muscle and Movement With Anti-Obesity Medications

NCT06645470 | Recruiting

• 2 other identifiers: STUDY00160240P20GM144269
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity and Overweight

Keywords

exercise; weight loss; obesity medication; obesity; overweight

Outcome Measures

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).

  0 and 6 months

Secondary Outcomes (17)

• Body Fat Mass

  0 and 6 months

• Percent Body Fat

  0 and 6 months

• Body Weight

  0 and 6 months; 6, 12, 18 weeks

• Body Height

  0 and 6 months; 6, 12, and 18 weeks

• Body Mass Index

  0 and 6 months; 6, 12, 18 weeks

Other Outcomes (4)

• Demographic Characteristics

  0 months

• Lifestyle and Health History

  0 months

• Medication History

  0 and 6 months; 6, 12, and 18 weeks

Study Arms (3)

Standard Medical Care

ACTIVE COMPARATOR

Standard Medical Care will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive brief contacts from the research staff at weeks 6, 12, and 18.

Other: Standard Medical Care (SMC); Behavioral: Monitoring Contacts; Other: Nutrition Education

Standard Medical Care plus Aerobic Training

EXPERIMENTAL

Standard Medical Care plus Aerobic Training will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive supervised aerobic exercise in addition to brief contacts from the research staff at weeks 6, 12, and 18.

Other: Standard Medical Care (SMC); Behavioral: Monitoring Contacts; Behavioral: Aerobic Training; Other: Nutrition Education

Standard Medical Care plus Resistance Training

EXPERIMENTAL

Standard Medical Care plus Resistance Training will continue to receive their regular standard clinical care during the 6-month intervention period of this study and will also receive supervised resistance exercise in addition to brief contacts from the research staff at weeks 6, 12, and 18.

Other: Standard Medical Care (SMC); Behavioral: Monitoring Contacts; Behavioral: Resistance Training; Other: Nutrition Education

Interventions

Standard Medical Care (SMC) OTHER

Standard Medical Care will continue to receive their regular standard clinical care during the 6-month intervention period of this study.

Standard Medical Care; Standard Medical Care plus Aerobic Training; Standard Medical Care plus Resistance Training

Monitoring Contacts BEHAVIORAL

Participants will receive contacts with the research staff at weeks 6, 12, and 18.

Standard Medical Care; Standard Medical Care plus Aerobic Training; Standard Medical Care plus Resistance Training

Aerobic Training BEHAVIORAL

Aerobic 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.

Standard Medical Care plus Aerobic Training

Resistance Training BEHAVIORAL

Resistance 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.

Standard Medical Care plus Resistance Training

Nutrition Education OTHER

A single counseling session to discuss the dietary recommendations when taking an obesity medication.

Standard Medical Care; Standard Medical Care plus Aerobic Training; Standard Medical Care plus Resistance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to provide informed consent prior to participation in this study.
• Clearance from the study physician for meeting all eligibility criteria for this study.

You may not qualify if:

• 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.
• Females who are pregnant, pregnant within the past 6 months, 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.).
• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Related Publications (1)

• Jakicic JM, Rogers RJ. The Role of Exercise in the Contemporary Era of Obesity Management Medications. Curr Sports Med Rep. 2025 Aug 1;24(8):240-245. doi: 10.1249/JSR.0000000000001272.

  PMID: 40758789 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity; Weight Loss

Interventions

Resistance Training; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Renee J. Rogers, Ph.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renee J. Rogers, Ph.D.

CONTACT

913-588-8580; rrogers10@kumc.edu

John M. Jakicic, Ph.D.

CONTACT

913-588-9078; jjakicic@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: 2-part design: (1) Randomized Pre-Post Parallel Design - 30 adults (18-\<59 years) will be recruited that are newly prescribed an anti-obesity medication and randomize 10 to each of the intervention conditions. Randomized to: 1. Standard Medical Care only, 2. Standard Medical Care + aerobic training, 3. Standard Medical Care + resistance training (2) Parallel longitudinal observational design - 10 older adults (\>= 60 years) will be recruited that are newly prescribed an anti-obesity medication for observation. An additional subset of older adults taking an Anti-Obesity Medication (no exercise training).

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: December 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be made available no later than the time of an associated publication of study outcomes or at the end of the performance period, whichever comes first. The data provided to the repository will be available indefinitely while that repository continues to exist.
• Access Criteria: The information included with the IPD will be made available to appropriate individuals only after the requester confirms their willingness to comply with an appropriate "Data Use Agreement" that complies with NIH policies, the policies of the institution where the study has been conducted, and the elements of informed consent.

Locations

US (1)