Trial Outcomes & Findings for Utilizing Protein During Weight Loss to Impact Physical Function (NCT NCT03074643)
NCT ID: NCT03074643
Last Updated: 2023-05-22
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
187 participants
Primary outcome timeframe
18 months
Results posted on
2023-05-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
62
|
63
|
|
Overall Study
COMPLETED
|
51
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Utilizing Protein During Weight Loss to Impact Physical Function
Baseline characteristics by cohort
| Measure |
RecProt
n=62 Participants
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.
|
6-month HiProt
n=62 Participants
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.
|
18-month HiProt
n=63 Participants
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.
|
Total
n=187 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.7 years
STANDARD_DEVIATION 4.4 • n=99 Participants
|
71.8 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
70.5 years
STANDARD_DEVIATION 3.9 • n=206 Participants
|
71.0 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
124 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
186 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Body mass index (BMI)
|
33.8 kg per meters squared
STANDARD_DEVIATION 4.6 • n=99 Participants
|
34.3 kg per meters squared
STANDARD_DEVIATION 3.5 • n=107 Participants
|
34.3 kg per meters squared
STANDARD_DEVIATION 4.2 • n=206 Participants
|
34.2 kg per meters squared
STANDARD_DEVIATION 4.1 • n=7 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: 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)
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
Outcome measures
| Measure |
RecProt
n=49 Participants
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.
|
6-month HiProt
n=47 Participants
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.
|
18-month HiProt
n=51 Participants
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.
|
|---|---|---|---|
|
Change in Expanded Short Physical Performance Battery Score
|
0.06 score on a scale
Standard Error 0.08
|
0.11 score on a scale
Standard Error 0.09
|
0.16 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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)
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
Outcome measures
| Measure |
RecProt
n=36 Participants
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.
|
6-month HiProt
n=36 Participants
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.
|
18-month HiProt
n=43 Participants
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.
|
|---|---|---|---|
|
Lower Extremity Muscle Strength
|
8.28 Newton meters
Standard Error 4.81
|
6.27 Newton meters
Standard Error 5.51
|
7.30 Newton meters
Standard Error 5.27
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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)
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
Outcome measures
| Measure |
RecProt
n=50 Participants
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.
|
6-month HiProt
n=49 Participants
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.
|
18-month HiProt
n=52 Participants
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.
|
|---|---|---|---|
|
Weight Change
|
-2.67 kilograms
Standard Error 1.22
|
-3.23 kilograms
Standard Error 1.26
|
-3.28 kilograms
Standard Error 1.29
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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)
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
Outcome measures
| Measure |
RecProt
n=49 Participants
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.
|
6-month HiProt
n=48 Participants
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.
|
18-month HiProt
n=50 Participants
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.
|
|---|---|---|---|
|
Total Body Lean Mass
|
-1.24 kilograms
Standard Error 0.48
|
-1.68 kilograms
Standard Error 0.50
|
-1.36 kilograms
Standard Error 0.52
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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)
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
Outcome measures
| Measure |
RecProt
n=49 Participants
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.
|
6-month HiProt
n=48 Participants
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.
|
18-month HiProt
n=50 Participants
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.
|
|---|---|---|---|
|
Total Body Fat Mass
|
-1.47 kilograms
Standard Error 0.92
|
-1.68 kilograms
Standard Error 0.95
|
-1.72 kilograms
Standard Error 0.98
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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)
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
Outcome measures
| Measure |
RecProt
n=44 Participants
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.
|
6-month HiProt
n=45 Participants
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.
|
18-month HiProt
n=45 Participants
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.
|
|---|---|---|---|
|
Thigh Muscle Volume
|
-3.76 cm^3
Standard Error 2.77
|
-5.40 cm^3
Standard Error 2.86
|
-8.42 cm^3
Standard Error 2.96
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: 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)
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
Outcome measures
| Measure |
RecProt
n=44 Participants
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.
|
6-month HiProt
n=45 Participants
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.
|
18-month HiProt
n=45 Participants
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.
|
|---|---|---|---|
|
Intermuscular Adipose Tissue
|
0.72 cm^3
Standard Error 0.62
|
0.44 cm^3
Standard Error 0.64
|
1.11 cm^3
Standard Error 0.66
|
Adverse Events
RecProt
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
6-month HiProt
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
18-month HiProt
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RecProt
n=62 participants at risk
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.
|
6-month HiProt
n=62 participants at risk
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.
|
18-month HiProt
n=63 participants at risk
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.
|
|---|---|---|---|
|
Immune system disorders
Anaphylaxis
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Infections and infestations
Lung Infection
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 2 • 18 months
|
0.00%
0/63 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Nervous system disorders
Cognitive Disturbance
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Knee Replacement
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Transurethral Resection Of Prostrate
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Shoulder Replacement
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Revision of Knee Replacement
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Surgical and medical procedures
Hip Replacement
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Umbilical Hernia Repair
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Cardiac disorders
Myocardial Infarction
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/62 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/63 • 18 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
1/62 • Number of events 1 • 18 months
|
0.00%
0/62 • 18 months
|
0.00%
0/63 • 18 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Surgical and medical procedures
Reverse Shoulder Arthroplasty
|
0.00%
0/62 • 18 months
|
0.00%
0/62 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
Other adverse events
| Measure |
RecProt
n=62 participants at risk
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.
|
6-month HiProt
n=62 participants at risk
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.
|
18-month HiProt
n=63 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Sinusitis
|
11.3%
7/62 • Number of events 8 • 18 months
|
3.2%
2/62 • Number of events 2 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Infections and infestations
Upper Respiratory Infection
|
1.6%
1/62 • Number of events 1 • 18 months
|
1.6%
1/62 • Number of events 1 • 18 months
|
6.3%
4/63 • Number of events 5 • 18 months
|
|
Injury, poisoning and procedural complications
Fall
|
11.3%
7/62 • Number of events 9 • 18 months
|
9.7%
6/62 • Number of events 6 • 18 months
|
6.3%
4/63 • Number of events 4 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/62 • 18 months
|
11.3%
7/62 • Number of events 7 • 18 months
|
1.6%
1/63 • Number of events 1 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.5%
4/62 • Number of events 4 • 18 months
|
4.8%
3/62 • Number of events 3 • 18 months
|
3.2%
2/63 • Number of events 2 • 18 months
|
Additional Information
Dr. Denise Houston
Wake Forest University School of Medicine
Phone: 336-713-8558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place