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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK141779-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care with an Obesity Management Medication | Experimental | Participants will receive standard medical care from their personal physician related to their obesity management medication for a period of 6 months. Progression of this medication will be monitored as part of the participation in this study. Participants will undergo screening and baseline assessments prior to initiating the use of the medication and after a period of 6 months. Upon randomization, participants will receive a "Nutrition 101" session where dietary considerations while taking this medication will be discussed. We will also have a brief contact (weeks 3, 6, 9, 12, 15, 18, and 21) with the participant to monitor changes in weight, blood pressure, health status, and medication adherence and use (including the dose of the obesity management medication that they have been prescribed). Participants will be instructed to maintain their current level of physical activity throughout the 6-month study period. |
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| Standard Care with an Obesity Management Medication Plus Cardiovascular Exercise Training | Experimental | Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised cardiovascular exercise training. This 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, we will allow for alternative forms of cardiovascular exercise (upright or recumbent cycling, elliptical, etc.) to accommodate any physical limitations that may be present for a participant. Heart rate will be monitored throughout these exercise sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Medical Care with an Obesity Management Medication | Other | Participant will receive standard medical care that includes the prescription and titration of a study eligible obesity management medication. |
| 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 |
|---|---|---|
| Muscle Mass | Muscle Mass (kg) will be assessed using the deuterated creatine (D3Cr) dilution method. | 0 and 6 months |
| Muscle Quality | Muscle quality will be assessed using magnetic resonance imaging (MRI) of the mid-thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Reporting | A questionnaire developed specifically for this study will be used to assess medication history and use of prescribed obesity management medications. 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, and weeks 3, 6, 9, 12, 15, 18, 21 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John M. Jakicic, PhD | Contact | 913-588-9078 | jjakicic@kumc.edu | |
| Renee J. Rogers, PhD | Contact | 913-588-8580 | rrogers10@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| John M. Jakicic, PhD | University of Kansas Medical Center | Principal Investigator |
| Renee J. Rogers, PhD | 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 |
The summary data for each of the study outcomes and other additional demographic characteristics will be made available.
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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| Standard Care with an Obesity Management Medication Plus Resistance Exercise Training | Experimental | Participants will receive the same standard of care as described for the "Standard Care with an Obesity Management Medication" condition; however, participants will also engage in supervised resistance exercise training. This will occur 3 days per week and involve 9 different exercises. Each exercise will progress to 3 sets with a rest period of 60 to 90 seconds between each set. Warm-up sets will include 10 repetitions, and all remaining sets will perform repetitions until volitional fatigue. Heart rate will be monitored throughout these exercise sessions. |
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| Cardiovascular Exercise Training | Behavioral | Participant will receive supervised cardiovascular exercise training on 3 days per week for a period of 6 months. |
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| Resistance Exercise Training | Behavioral | Participant will receive supervised resistance exercise training on 3 days per week for a period of 6 months. |
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| Nutrition Counseling | Behavioral | Participant will receive brief nutrition counseling specific to obesity managment medications after randomization for this study. |
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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 months, week 6, week 12, week 18, 6 months |
| Body Mass Index | Measurements of weight and height will be used to compute BMI (kg/m2). | 0 months, week 6, week 12, week 18, 6 months |
| Percent body fat | Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). | 0 and 6 months |
| 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 |
| Bone mineral content | Bone mineral content (grams) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA). | 0 and 6 months |
| Bone mineral density | Bone mineral density (g/cm2) will be assessed using total body, femur, and spine scans from dual-energy x-ray absorptiometry (DXA). | 0 and 6 months |
| Bone Biomarkers | Bone biomarkers will be assessed from blood samples collected using venipuncture. | 0 and 6 months |
| Waist Circumference | Circumference measures of the waist will be taken horizontally at both the iliac crest and the umbilicus. | 0 and 6 months |
| Hip Circumference | Circumference measures of the hip will be taken horizontally at the widest observed portion of the buttocks. | 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 or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale. | 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 or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale. | 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 or if taking a medication that will impact heart rate response to exercise, then achieving a Rating of Perceived Exertion (RPE) of 16 on the 6-20 scale. | 0 and 6 months |
| Muscle Strength | Muscular strength will be measured from an isometric leg extension performed on a dynamometer. | 0 and 6 months |
| Physical Function | Physical function will be measured using the Short Physical Performance Protocol (SPPB) that includes balance, gait speed, and chair stands). | 0 and 6 months |
| Muscle Power | Muscle Power is measured using the Margaria Power Stair Climb Task that requires the participant to walk up a standardized flight of stair, with the score being the time it takes to walk from the 3rd step to the 9th step. A faster time at a given body mass indicates a greater level of muscle power. | 0 and 6 months |
| Health-Related Quality of Life | Health-related quality of life is assessed with a standardized questionnaire. This questionnaire consists of 8 scales (physical functioning, role limitations caused by health problems, role limitation caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, general health perceptions) with each scale score between 0-100. This also consists of 2 subscales (physical and mental health) with these being scored as the average of the scores from the scales that are factored into each measure. This also provides an overall score, which is the average of the scores for each of the 8 scales. A higher score on a scale or subscale indicates a higher health-related quality of life. | 0 and 6 months |
| 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 months, week 6, week 12, week 18, 6 months |
| Energy Intake (Dietary Intake) | Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using a 3-day dietary recall (2 weekdays and 1 weekend day). A higher score represents more calories eaten. | 0 months, week 6, week 12, week 18, 6 months |
| Physical Activity | Physical activity will be measured using the Physical Activity and Exercise Questionnaire. A higher score represents more physical activity expressed as minutes per week or calories of energy expenditure per week. | 0 and 6 months |
| Physical Activity | Physical activity will be measured using the Global Physical Activity Questionnaire (GPAQ). A higher score represents more physical activity expressed as minutes per week or calories of energy expenditure per week. | 0 and 6 months |
| Physical Activity | Physical activity will be measured Garmin wrist worn activity tracker that will be provided to each participant to wear throughout the entire 6 month intervention period. A higher score represents more physical activity. | 0 and 6 months |
| Obesity Management Medication Adherence | A questionnaire developed specifically for this study will be used to assess adherence to the prescribed obesity management medications. The data collected include the type of medication, dose of medication, and frequency that the medication is taken. | 0 and 6 months, and weeks 3, 6, 9, 12, 15, 18, 21 |
| Demographic Characteristics | A questionnaire developed specifically for this study will be used to assessment demographic characteristics (age, sex, race, etc.). | 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. | 0 months (prior to randomization) |
| 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, and weeks 3, 6, 9, 12, 15, 18, 21 and at other times when reported by the participant |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| 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 |
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