Trial Outcomes & Findings for Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study (NCT NCT04870515)
NCT ID: NCT04870515
Last Updated: 2026-01-09
Results Overview
Change in body weight from baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
0 months, 6 months
Results posted on
2026-01-09
Participant Flow
Participant milestones
| Measure |
Group I (Diet, Physical Activity)
Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruction on following a healthy diet pattern. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction on aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
Patients receive standard lifestyle recommendations and attend a single individual session with a dietitian to review the US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Group I (Diet, Physical Activity)
Patients attend 10 in-person or virtual sessions with a registered dietitian over 6 months to receive instruction on following a healthy diet pattern. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction on aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
Patients receive standard lifestyle recommendations and attend a single individual session with a dietitian to review the US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Withdrawal due to complications with standard of care treatment
|
2
|
0
|
Baseline Characteristics
Diet and Physical Activity Intervention for the Prevention of ADT-Induced Metabolic Changes in Patients With Prostate Cancer, TRIPLE-A PILOT Study
Baseline characteristics by cohort
| Measure |
Group I (Diet, Physical Activity)
n=9 Participants
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
n=11 Participants
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
Best Practice: Receive standard lifestyle recommendations
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 5.7 • n=9 Participants
|
73.6 years
STANDARD_DEVIATION 4.5 • n=6 Participants
|
72.43 years
STANDARD_DEVIATION 5.12 • n=9 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
19 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
11 participants
n=6 Participants
|
20 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 0 months, 6 monthsData is reported as a percentage change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score from baseline. HOMA-IR is an index to estimate the insulin resistance of a patient. HOMA-IR is defined as (glucose (mg/dl) insulin (uIU/ml)) / 405.
Outcome measures
| Measure |
Group I (Diet, Physical Activity)
n=7 Participants
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
n=8 Participants
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
Best Practice: Receive standard lifestyle recommendations
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effects of the Intervention on ADT-induced Changes in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
|
4.5 percentage change
Standard Deviation 52.1
|
42.7 percentage change
Standard Deviation 28.1
|
PRIMARY outcome
Timeframe: 0 months, 6 monthsChange in body weight from baseline.
Outcome measures
| Measure |
Group I (Diet, Physical Activity)
n=7 Participants
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
n=8 Participants
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
Best Practice: Receive standard lifestyle recommendations
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effects of the Intervention on ADT-induced Changes in Body Weight
|
-1.24 kg
Standard Deviation 2.6
|
1.01 kg
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 0 months, 6 monthsChange in waist circumference from baseline. Waist circumference was measured at 1" above umbilicus.
Outcome measures
| Measure |
Group I (Diet, Physical Activity)
n=7 Participants
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
n=8 Participants
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
Best Practice: Receive standard lifestyle recommendations
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effects of the Intervention on ADT-induced Changes in Waist Circumference
|
3.4 cm
Standard Deviation 1.5
|
1.8 cm
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: 0 months, 6 monthsChange in lean mass from baseline. Lean mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).
Outcome measures
| Measure |
Group I (Diet, Physical Activity)
n=7 Participants
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
n=8 Participants
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
Best Practice: Receive standard lifestyle recommendations
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effects of the Intervention on ADT-induced Changes in Lean Mass
|
-998 g
Standard Deviation 1604
|
-1129 g
Standard Deviation 1423
|
PRIMARY outcome
Timeframe: 0 months, 6 monthsChange in fat mass from baseline. Fat mass was measured by Dual-Energy X-ray Absorptiometry (DEXA).
Outcome measures
| Measure |
Group I (Diet, Physical Activity)
n=7 Participants
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
n=8 Participants
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
Best Practice: Receive standard lifestyle recommendations
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Effects of the Intervention on ADT-induced Changes in Fat Mass
|
1307 g
Standard Deviation 2984
|
2491 g
Standard Deviation 1189
|
Adverse Events
Group I (Diet, Physical Activity)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group II (Standard Lifestyle Recommendations)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group I (Diet, Physical Activity)
n=9 participants at risk
Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.
Dietary Intervention: Receive dietary instructions
Exercise Intervention: Complete aerobic and strength/resistance exercises
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group II (Standard Lifestyle Recommendations)
n=11 participants at risk
Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.
Best Practice: Receive standard lifestyle recommendations
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
11.1%
1/9 • Number of events 1 • up to 6 months
|
0.00%
0/11 • up to 6 months
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • up to 6 months
|
0.00%
0/11 • up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Hip and back pain
|
11.1%
1/9 • Number of events 1 • up to 6 months
|
0.00%
0/11 • up to 6 months
|
|
Hepatobiliary disorders
elevated liver function tests
|
11.1%
1/9 • Number of events 1 • up to 6 months
|
0.00%
0/11 • up to 6 months
|
|
Renal and urinary disorders
Urinary retention
|
11.1%
1/9 • Number of events 1 • up to 6 months
|
0.00%
0/11 • up to 6 months
|
|
Cardiac disorders
Presyncope
|
11.1%
1/9 • Number of events 1 • up to 6 months
|
0.00%
0/11 • up to 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place