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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM144269 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Fat Mass | Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). | 0 and 6 months |
| Percent Body Fat | Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Characteristics | Demographic Characteristics will be assessed using a survey. | 0 months |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renee J. Rogers, Ph.D. | Contact | 913-588-8580 | rrogers10@kumc.edu | |
| John M. Jakicic, Ph.D. | Contact | 913-588-9078 | jjakicic@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Renee J. Rogers, Ph.D. | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40758789 | Derived | 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. |
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The summary data for each of the study outcomes and other additional demographic characteristics will be made available. The Study Protocol (which includes the statistical analysis plan), Manual of Procedures, Data Collection Forms, and a Data Dictionary to explain the data variables will be provided.
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.
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.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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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:
(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).
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| Monitoring Contacts | Behavioral | Participants will receive contacts with the research staff at weeks 6, 12, and 18. |
|
| 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. |
|
| 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. |
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| Nutrition Education | Other | A single counseling session to discuss the dietary recommendations when taking an obesity medication. |
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| 0 and 6 months |
| Body Weight | Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg. | 0 and 6 months; 6, 12, 18 weeks |
| Body Height | Body height will be assessed in duplicate using a wall mounted stadiometer to the nearest 0.1 cm. | 0 and 6 months; 6, 12, and 18 weeks |
| Body Mass Index | Measurements of weight and height will be used to compute BMI (kg/m2). | 0 and 6 months; 6, 12, 18 weeks |
| Bone Mineral Content | Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). | o and 6 months |
| Muscle Mass | Muscle mass will be assessed using the deuterated creatine (D3Cr) dilution method. A 30mg capsule of D3Cr is ingested and 48-72 hrs later, a fasting urine sample is provided for analysis. | 0 and 6 months |
| Muscular Strength | Muscular strength will be assessed using isometric leg extension on a Biodex. | 0 and 6 months |
| Muscular Strength | Muscular strength will be assessed using grip strength with a hand grip dynamometer. | 0 and 6 months |
| Physical Function | Physical Function will be assessed using the Short Physical Performance Battery (SPPB) that includes balance, gait speed, and chair stands. A composite score with a range from 0 to 12 (no units) of these measures is used. A higher score represents better physical functioning. | 0 and 6 months |
| Cardiorespiratory Fitness | 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. | 0 and 6 months |
| Cardiorespiratory Fitness | 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. | 0 and 6 months |
| Cardiorespiratory Fitness | 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. | 0 and 6 months |
| Resting Blood Pressure | Resting seated blood pressure, both systolic and diastolic (mmHg), will be assessed using an automated system. | 0 and 6 months; 6, 12, and 18 weeks |
| Energy Intake (Dietary Intake) | 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. | 0 and 6 months |
| Physical Activity | Physical activity is measured by the Global Physical Activity Questionnaire (GPAQ). This assesses time spent in recreational, occupational, household, and transportation physical activities and is represented as minutes per week. Higher minutes per week indicate greater physical activity participation. The range is 0 to 10,080 minutes per week. | 0 and 6 months |
| Health-Related Quality of Life | Health-Related Quality of Life will be measured with a 36-item questionnaire (RAND 36-Item Health Survey) that includes 8 subscales of vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health or emotional wellbeing. All items are scored so that a high score defines a more favorable health state. The range of the final score for each subscale is 0-100. | 0 and 6 months |
| 0 months |
| 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. | 0 and 6 months; 6, 12, and 18 weeks |
| 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. | 0 and 6 months; 6, 12, and 18 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |