Changes in Body Composition Including Muscle With Anti-Obesity Medications, Both With and Without Exercise

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.

Conditions

• Obesity & Overweight

Interventions

BEHAVIORAL

Nutrition Counseling

Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study.

OTHER

Standard 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.

BEHAVIORAL

Cardiovascular Exercise Training

Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months.

BEHAVIORAL

Resistance Exercise Training

Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Kansas Medical Center

  lead OTHER

Principal Investigators

• John M. Jakicic, PhD · University of Kansas Medical Center

• Renee J. Rogers, PhD · University of Kansas Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2030-03-31

Completion

2030-03-31

Countries

• United States

Study Locations