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Muscle CompositionSTRONGNCT07652333

The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication

A study testing Resistance Exercise and GLP-1 RAs in people with Muscle Composition and Obesity, run by University of Pittsburgh at 1 site in United States.

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Sites and contacts
Official record

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Trial summary

The purpose of this study is to examine the effects of resistance exercise, such as weightlifting, on retention of muscle mass and mental health in individuals taking GLP-1 RAs (an obesity medication). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle Composition, Obesity, Quality of Life (QOL)
What is being tested?
Resistance Exercise and GLP-1 RAs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
25 May 2026to 31 May 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Initiating GLP-1 RAs prescribed by physician or advanced practice practitioner and willing to withhold the start of the drug until baseline assessment completed
  • Non-Smoker
  • ≥18 years old
  • Obese: Body Mass Index 30-45 kg/m² or BMI ≥27 + ≥1 weight related comorbidity; either hypertension or sleep apnea confirmed by participant self-report
  • Inactive: not meeting the current US exercise guidelines over the past 6 months
  • Capable of performing the required exercise training

Who cannot join

  • A serious heart condition, such as unstable heart disease or heart failure, irregular heartbeats that are not well controlled, severe narrowing of the heart valves, or any recent inflammation of the heart or its lining
  • Cancer requiring treatment in the past 5 years
  • Hypothyroidism/hyperthyroidism
  • Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome type 2 (MEN2)
  • Gastroparesis
  • Chronic/idiopathic acute pancreatitis
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  • Hepatic disease or cirrhosis
  • Struggle with alcohol or other substance abuse (heavy drinking (≥4 drinks/day or ≥8 drinks/week for women; ≥5 drinks/day or ≥15 drinks/week for men), or who score ≥3 on the Drug Abuse Screening Test (DAST-10))
  • Diabetes (Type 1 or 2)
  • Major risk factors for coronary heart disease such as uncontrolled high blood pressure (≥160 mm Hg systolic or ≥100 mm Hg diastolic)
  • Problems with your muscles or bones that limit your ability to exercise
  • Any other medical condition that is life-threatening, can interfere with or be aggravated by the exercise training
  • Plans to be away ≥2 weeks in the next 3 months
  • Participation in any other concurrent interventional clinical trial
  • History of eating disorders or weight-loss surgery, unstable weight (±5% change in past 6 months), or use of obesity medication (e.g., such as Wegovy, Ozempic, Saxenda, Zepbound, Mounjaro) in the last 3 months
  • Inability to give informed consent
  • History of major depression or other severe psychiatric disorders (e.g., who answer "yes" to question 9 on PHQ-9 in the Psych_QoL_Sleep questionnaires.)
  • Pregnant or plan to become pregnant during study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiyeon Yoon, M.S. contact

512-817-4601

jiy239@pitt.edu

United States1 site, 1 recruiting
  • Physical Activity Research Center, University of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

    Jiyeon Yoon, M.S., 515-817-4601, jiy239@pitt.edu

    Recruiting

Other trials in United States

About this study

Official title: The Effects of Strength Training on Muscle Mass and Mental Health in Adults Taking Obesity Medication: A Pilot Study

The purpose of this study is to examine the effects of resistance exercise, such as weightlifting, on retention of muscle mass and mental health in individuals taking GLP-1 RAs (an obesity medication). Resistance exercise is focused on increasing the strength of participants' muscles, such as how much participant can lift.

•The duration of this study is 3 months. This includes:

  • Orientation session to explain study protocol, exercise program, and complete questionnaire about participants' medical history and lifestyle.
  • Two health assessments at baseline and at 3 months. These assessments include body composition, resting blood pressure, cardiovascular function, and muscular strength. Both the resistance exercise group and the control group will complete assessments at baseline and again at 3 months. After the 3-month period, individuals in the control group may choose to participate in the exercise training and complete the optional 6-month assessments.
  • Personalized resistance exercise sessions for 60 minutes per session, twice per week, for 3 months.
Read the detailed description
  • After the baseline assessment, if participants meet all eligibility criteria such as BMI, blood pressure, physical activity levels, and medication conditions, investigators will randomly assign participants to control group or resistance exercise group:
  1. Control group: No resistance training during the first 3 months. After the 3-month period, participants may choose to participate in the optional exercise program, which includes 60 min/session, all for 2 sessions/week for 3 months. Participants may follow their provider's guidance for exercise except not to perform any strength or resistance training.
  2. Resistance exercise group: 60 min/session, all for 2 sessions/week for 3 months.
  • Resistance exercise group (60 min/session): Each session will be 60 minutes of resistance, performing 3 sets of 8-20 repetitions (50-80% 1RM) of 11 exercises (chest press, lat pulldown, abdominal crunch, leg press, shoulder press, weighted row, leg extension, leg curl, chest fly, biceps curl, and triceps extension) using weight training machines.

Investigator will also ask participants to maintain their usual (pre-study) lifestyle physical activity outside of exercise sessions and to monitor participants' daily activity throughout the study period using pedometers and a lifestyle activity log.

Being tested
Resistance Exercise, GLP-1 RAs
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance ExerciseBehavioural

    60 min/session, all for 2 sessions/week for 12 weeks

  • GLP-1 RAsDrug

    Participants will take GLP-1 RAs for 12 weeks

Study groups in NCT07652333
Study groupRoleWhat they receive
Resistance Exercise (RE)ExperimentalParticipants will perform 60 min of resistance exercise 2 sessions per week for 12 weeks while continuing GLP-1 RAs therapy as prescribed by regular treating provider
Receives: Behavioral: Resistance Exercise; Drug: GLP-1 RAs
Standard CareActive comparatorParticipants will take GLP-1 RAs for 12 weeks as prescribed by regular treating provider
Receives: Drug: GLP-1 RAs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Body Composition

    Dual-energy X-ray absorptiometry (DEXA) will be used to assess fat mass and lean mass. Body fat will be expressed as a percentage of total body composition, and lean mass will be expressed as a percentage of total body composition. Change in each variable will be calculated as the Week 12 value minus the baseline value. Positive values indicate an increase in body fat or lean mass, and negative values indicate a decrease.

    Measured: From Baseline to Week 12

  2. Change in Quality of Life

    Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better quality of life. Change will be calculated as Week 12 minus baseline.

    Measured: From Baseline to Week 12

Secondary outcomes (3)
  1. Muscle Strength

    Grip strength will be measured three times in each hand using a Jamar dynamometer, and one-repetition maximum (1RM) will be measured using leg press and chest press machines.

    Measured: From Baseline to Week 12

  2. Energy Intake

    Energy intake will be assessed using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool.

    Measured: From Baseline to Week 12

  3. Physical Activity and Sleep

    Participants will be asked to wear a GENEActiv tri-axial wrist-worn accelerometer for a 7-day period to quantify physical activity and sedentary behavior. Participants will be instructed to wear the device continuously for 24 hours per day throughout the 7-day measurement period.

    Measured: From Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start25 May 2026
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07652333
Sponsor's protocol ID
STUDY25090068
Acronym
STRONG
Status last verified
Jun 2026
First submitted
11 Jan 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Datasets will be available to outside researchers and public health professionals through the web sites of ClinicalTrials.gov and The Physical Activity Research Center (PARC) at the University of Pittsburgh. Outside researchers can learn what data are available and request a de-identified dataset (stripped of all personal health identifiers). All data requests will be discussed with the research team and approval will be obtained from the institutional review board overseeing the proposal of the data analysis project. Findings from the proposed study will also be published in peer-reviewed journals. The investigators seek to maximize the knowledge generated from this study by sharing data to expedite the translation of research into practice, with the goal of preserving lean body mass and improving quality of life.

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