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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG050656 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study will evaluate the effects of diet composition (i.e., amount of protein and carbohydrate) during a 6-month weight loss intervention and 12-months of follow-up on physical function, muscle mass, and weight loss maintenance in obese older adults. Participants will receive either a protein or carbohydrate supplement along with a behavioral weight loss intervention.
The study will use a 3-group design in 225 obese (BMI 27-45 kg/m2), older (65-85 years) men and women at risk for disability (eSPPB <2.5) who will undergo a 6-month weight loss intervention followed by a 12-month follow-up phase to test the overall hypothesis that a higher protein (1.2 g/kg body wt/d) / lower carbohydrate (CHO) diet during a 6-month weight loss intervention improves physical function compared with an isocaloric lower protein (the current Recommended Dietary Allowance (RDA), 0.8 g/kg body wt/d) / higher CHO diet, and whether continuing a higher protein / lower CHO diet for 12-months following weight loss will result in better maintenance of improved physical function. All participants will undergo a 6-month weight loss intervention involving caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt). Physical function (primary aim) will be assessed by the expanded Short Physical Performance Battery (primary outcome) and lower extremity muscle strength at baseline, 6-, 12- and 18-months. Weight loss maintenance and body composition (secondary aim) will be assessed by dual-energy X-ray absorptiometry (DXA) and computed tomography (CT) at baseline, 6- and 18-months. Bone mineral density (DXA) and cardiometabolic risk factors will also be measured at baseline, 6- and 18-months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RecProt | Placebo Comparator | Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18. |
|
| 6-mon HiProt | Active Comparator | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. |
|
| 18-mon HiProt | Active Comparator | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss intervention months 0-6 | Behavioral | All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Expanded Short Physical Performance Battery Score | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity physical function assessed by the expanded Short Physical Performance Battery score over 18 months. The expanded Short Physical Performance Battery score ranges from 0 to 4 with higher scores indicating better lower extremity physical function | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Extremity Muscle Strength | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity muscle strength assessed using an isokinetic dynamometer (Biodex) over 18 months | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Houston, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Research Center at Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RecProt | Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults. Carbohydrate supplement for months 0-6: Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 2, 2022 |
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All participants will undergo a 6-month weight loss intervention of caloric restriction and supervised exercise followed by 12 months of follow-up with randomization to one of three groups (n=75/group): 1) Lower protein / higher CHO diet for the 6-month weight loss phase only (RecProt); 2) Higher protein / lower CHO diet for the 6-month weight loss phase only (6-mo HiProt); or 3) Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases (18-mo HiProt).
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| Exercise intervention months 0-6 | Behavioral | All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults. |
|
| Carbohydrate supplement for months 0-6 | Dietary Supplement | Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention. |
|
| Protein supplement for months 0-6 | Dietary Supplement | Participants in the higher protein / lower CHO diet groups (6-mon HiProt and 18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
|
| Protein supplement for follow-up months 7-18 | Dietary Supplement | Participants in the higher protein / lower CHO diet (18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 12-month follow-up. |
|
| Weight Change |
To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in body weight over 18 months |
| 18 months |
| Total Body Lean Mass | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in dual energy x-ray (DXA) acquired total body lean mass over 18 months | 18 months |
| Total Body Fat Mass | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in dual energy x-ray acquired (DXA) total body fat mass over 18 months | 18 months |
| Thigh Muscle Volume | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in computerized tomography (CT) acquired thigh muscle volume over 18 months | 18 months |
| Intermuscular Adipose Tissue | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in computerized tomography (CT) acquired thigh intermuscular adipose tissue over 18 months | 18 months |
| FG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| FG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RecProt | Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults. Carbohydrate supplement for months 0-6: Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention. |
| BG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| BG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index (BMI) | Mean | Standard Deviation | kg per meters squared |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Expanded Short Physical Performance Battery Score | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity physical function assessed by the expanded Short Physical Performance Battery score over 18 months. The expanded Short Physical Performance Battery score ranges from 0 to 4 with higher scores indicating better lower extremity physical function | 6 participants were missing the expanded Short Physical Performance battery at 18 month follow-up: 1 participant refused the test due to severe back pain (RecProt), 3 participants refused an in-person clinic visit due to COVID-19 concerns (1 per group); 1 participant moved out of state and only completed a phone visit (6-month HiProt); and 1 participant refused to complete the expanded Short Physical Performance Battery (6-month HiProt) | Posted | Least Squares Mean | Standard Error | score on a scale | 18 months |
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| Secondary | Lower Extremity Muscle Strength | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in lower extremity muscle strength assessed using an isokinetic dynamometer (Biodex) over 18 months | 38 participants were missing leg strength: 34 were excluded from testing due to knee replacements, severe knee arthritis/pain, recent eye surgery or chest pain, history of brain aneurysms, or uncontrolled blood pressure (14 RecProt, 12 6-mo HiProt, 8 18-mo HiProt); 3 participants refused an in-person clinic visit due to COVID-19 concerns (1 per group); and 1 participant moved out of state and only completed a phone visit (6-mo HiProt) | Posted | Least Squares Mean | Standard Error | Newton meters | 18 months |
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| Secondary | Weight Change | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in body weight over 18 months | Weight was not available at 18 month follow-up in 2 participants: 1 participant moved out of state and only completed a phone visit (6-month HiProt) and 1 participant refused an in-person visit at 18 months due to COVID-19 concerns (RecProt) | Posted | Least Squares Mean | Standard Error | kilograms | 18 months |
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| Secondary | Total Body Lean Mass | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in dual energy x-ray (DXA) acquired total body lean mass over 18 months | 6 participants were missing DXA-acquired total body lean mass: 4 participants refused in-person visits due to COVID-19 concerns (1 RecProt, 1 6-m HiProt, 2 18-m HiProt), 1 participant moved out of state and only did a phone visit at follow-up (6-m HiProt), and there was a DXA machine malfunction for 1 participant (RecProt) | Posted | Least Squares Mean | Standard Error | kilograms | 18 months |
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| Secondary | Total Body Fat Mass | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in dual energy x-ray acquired (DXA) total body fat mass over 18 months | 6 participants were missing DXA-acquired total body fat mass: 4 participants refused in-person visits due to COVID-19 concerns (1 RecProt, 1 6-m HiProt, 2 18-m HiProt), 1 participant moved out of state and only did a phone visit at follow-up (6-m HiProt), and there was a DXA machine malfunction for 1 participant (RecProt) | Posted | Least Squares Mean | Standard Error | kilograms | 18 months |
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| Secondary | Thigh Muscle Volume | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in computerized tomography (CT) acquired thigh muscle volume over 18 months | 19 participants were missing CT-acquired thigh muscle volume: 10 participants refused the CT scan (5 RecProt, 2 6-m HiProt, 3 18-m HiProt); 4 participants had CT scans that were unable to be processed (1 RecProt, 1 6-m HiProt, 2 18-m HiProt); 3 participants refused in-person visits due to COVID-19 concerns (1 per group), 1 participant moved out of state and only did a phone visit at follow-up (6-m HiProt), and 1 person had a hip replacement of the leg scanned at baseline (18-m HiProt) | Posted | Least Squares Mean | Standard Error | cm^3 | 18 months |
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| Secondary | Intermuscular Adipose Tissue | To determine the effects of a higher protein / lower CHO diet vs. lower protein / higher CHO diet during a 6-month weight loss intervention and 12 months of follow-up on change in computerized tomography (CT) acquired thigh intermuscular adipose tissue over 18 months | 19 participants were missing CT-acquired intermuscular adipose tissue: 10 participants refused the CT scan (5 RecProt, 2 6-m HiProt, 3 18-m HiProt); 4 participants had CT scans that were unable to be processed (1 RecProt, 1 6-m HiProt, 2 18-m HiProt); 3 participants refused in-person visits due to COVID-19 concerns (1 per group), 1 participant moved out of state and only did a phone visit at follow-up (6-m HiProt), and 1 person had a hip replacement of the leg scanned at baseline (18-m HiProt) | Posted | Least Squares Mean | Standard Error | cm^3 | 18 months |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RecProt | Lower protein / higher CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Carbohydrate supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults. Carbohydrate supplement for months 0-6: Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention. | 0 | 62 | 8 | 62 | 17 | 62 |
| EG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. | 0 | 62 | 5 | 62 | 14 | 62 |
| EG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. | 0 | 63 | 5 | 63 | 11 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylaxis | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Lung Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Cognitive Disturbance | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Knee Replacement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Transurethral Resection Of Prostrate | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Shoulder Replacement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Revision of Knee Replacement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Hip Replacement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Umbilical Hernia Repair | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Chest Pain | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Reverse Shoulder Arthroplasty | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
We initially planned to end recruitment in August of 2020. However, our institution paused all in-person research from March 13, 2020 through May 31, 2020 due to the COVID19 pandemic. We extended our recruitment window through September 2020 but did not reach our target enrollment. The COVID19 pandemic also affected participant follow-up (a large number of out of window visits and a few who refused to return for in-person visits). The 6-month intervention also had to go remote for ~4 months.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise Houston | Wake Forest University School of Medicine | 336-713-8558 | dhouston@wakehealth.edu |
| Apr 20, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2021 | Jun 30, 2022 | ICF_000.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 0.45 |
| Superiority |
| OG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| OG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
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| OG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| OG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
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| OG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| OG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
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| OG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| OG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
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| OG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| OG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
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| OG001 | 6-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss phase. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association (AHA) and the American College of Sports Medicine (ACSM) physical activity recommendations for older adults. Protein supplement for months 0-6: Participants in the 6-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. |
| OG002 | 18-month HiProt | Higher protein / lower CHO diet for the 6-month weight loss and 12-month follow-up phases. Exercise intervention months 0-6. Weight loss intervention months 0-6. Protein supplement for months 0-6 (blinded). Protein supplement for follow-up months 7-18. Weight loss intervention months 0-6: All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month). Exercise intervention months 0-6: All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the AHA and the ACSM physical activity recommendations for older adults. Protein supplement for months 0-18: Participants in the 18-month higher protein / lower CHO diet groups will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention and 12 month follow-up. |
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