Trial Outcomes & Findings for Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer (NCT NCT02454517)
NCT ID: NCT02454517
Last Updated: 2023-01-04
Results Overview
Mean and standard deviation of change from baseline.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2023-01-04
Participant Flow
Participant milestones
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
The goals of the diet and exercise lifestyle intervention is for patients to lose 7% total body weight. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
Behavioral Dietary Intervention: Undergo DPP lifestyle intervention
Exercise Intervention: Undergo DPP lifestyle intervention
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Control)
Patients receive an informational intervention along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week.
Informational Intervention: Receive oral and written guidelines and meet with dietitian.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
The goals of the diet and exercise lifestyle intervention is for patients to lose 7% total body weight. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
Behavioral Dietary Intervention: Undergo DPP lifestyle intervention
Exercise Intervention: Undergo DPP lifestyle intervention
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Control)
Patients receive an informational intervention along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week.
Informational Intervention: Receive oral and written guidelines and meet with dietitian.
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
|
Overall Study
Discontinued Active surveillance and underwent treatment
|
1
|
2
|
Baseline Characteristics
Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
n=58 Participants
The goals of the diet and exercise lifestyle intervention is for patients to lose 7% total body weight. Patients meet with a nutritionist 11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
Behavioral Dietary Intervention: Undergo DPP lifestyle intervention
Exercise Intervention: Undergo DPP lifestyle intervention
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Arm II (Control)
n=59 Participants
Patients receive an informational intervention along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week.
Informational Intervention: Receive oral and written guidelines and meet with dietician
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Continuous
|
66.6 years
n=5 Participants
|
67.0 years
n=7 Participants
|
66.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
59 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Glucose
|
73.5 mg/dL
STANDARD_DEVIATION 19.1 • n=5 Participants
|
76.0 mg/dL
STANDARD_DEVIATION 24.3 • n=7 Participants
|
74.8 mg/dL
STANDARD_DEVIATION 21.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants that completed the 6 month visit
Mean and standard deviation of change from baseline.
Outcome measures
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
n=50 Participants
Intervention based on the Diabetes Prevention Program for weight loss. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
|
Arm II (Control)
n=50 Participants
General guidance on weight loss, healthy diet and physical activity provided in a single session (20 - 30 minutes).
|
|---|---|---|
|
Change From Baseline in Fasting Glucose at 6 Months
|
-3.65 mg/dL
Standard Deviation 21
|
4.5 mg/dL
Standard Deviation 47
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants who completed the 6 month study visit
Mean and standard deviation of change from baseline.
Outcome measures
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
n=50 Participants
Intervention based on the Diabetes Prevention Program for weight loss. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
|
Arm II (Control)
n=50 Participants
General guidance on weight loss, healthy diet and physical activity provided in a single session (20 - 30 minutes).
|
|---|---|---|
|
Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
C-peptide (ng/mL)
|
-0.55 ng/ml
Standard Deviation 0.72
|
0.06 ng/ml
Standard Deviation 0.65
|
|
Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
IGF-BP3 (ng/mL)
|
-363 ng/ml
Standard Deviation 818
|
-297 ng/ml
Standard Deviation 881
|
|
Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
IGF-1 (ng/mL)
|
6.2 ng/ml
Standard Deviation 54
|
-4.7 ng/ml
Standard Deviation 51
|
|
Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
Adiponectin (ng/mL)
|
696 ng/ml
Standard Deviation 3124
|
4.2 ng/ml
Standard Deviation 1652
|
PRIMARY outcome
Timeframe: Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization)Population: Data were not collected due to lack of funding.
Mean and standard deviation of change from baseline.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 months (6 months after active intervention)Population: Participants who completed the month 12 study visit
Mean and standard deviation of weight at 12 months
Outcome measures
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
n=36 Participants
Intervention based on the Diabetes Prevention Program for weight loss. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
|
Arm II (Control)
n=42 Participants
General guidance on weight loss, healthy diet and physical activity provided in a single session (20 - 30 minutes).
|
|---|---|---|
|
Weight at 12 Months
|
90.0 kilograms
Standard Deviation 14.3
|
99.2 kilograms
Standard Deviation 20.1
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants who completed the 6 month study visit
Mean and standard deviation of change from baseline.
Outcome measures
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
n=50 Participants
Intervention based on the Diabetes Prevention Program for weight loss. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
|
Arm II (Control)
n=50 Participants
General guidance on weight loss, healthy diet and physical activity provided in a single session (20 - 30 minutes).
|
|---|---|---|
|
Change From Baseline in Fasting Insulin at 6 Months
|
-2.3 mUI/L
Standard Deviation 4.9
|
-0.19 mUI/L
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Participants who completed the 6 month study visit
Mean and standard deviation of Quality of Life measures at 6 months.
Outcome measures
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
n=50 Participants
Intervention based on the Diabetes Prevention Program for weight loss. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
|
Arm II (Control)
n=49 Participants
General guidance on weight loss, healthy diet and physical activity provided in a single session (20 - 30 minutes).
|
|---|---|---|
|
Health Related Quality of Life (HRQOL) at 6 Months
Overall Anxiety (MAX-PC); range 0-54, higher score indicates more anxiety
|
16.9 score on a scale
Standard Deviation 7.5
|
16.6 score on a scale
Standard Deviation 6.3
|
|
Health Related Quality of Life (HRQOL) at 6 Months
Urinary Quality of Life (EPIC-26); range 0-100, higher score indicates better urinary QOL
|
88.1 score on a scale
Standard Deviation 11.6
|
82.9 score on a scale
Standard Deviation 12.7
|
Adverse Events
Arm I (Diet and Exercise Lifestyle Intervention)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Arm II (Control)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Diet and Exercise Lifestyle Intervention)
n=58 participants at risk
Intervention based on the Diabetes Prevention Program for weight loss. Patients meet with a dietitian11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
|
Arm II (Control)
n=59 participants at risk
General guidance on weight loss, healthy diet and physical activity provided in a single session (20 - 30 minutes).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arthralgia
|
12.1%
7/58 • Number of events 7 • 6 months
|
0.00%
0/59 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/59 • 6 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/59 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back surgery
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/59 • 6 months
|
|
Surgical and medical procedures
Transurethral resection of the prostate
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/59 • 6 months
|
|
Injury, poisoning and procedural complications
Rectal hemorrhage
|
1.7%
1/58 • Number of events 1 • 6 months
|
1.7%
1/59 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Cystitis, non-infective
|
1.7%
1/58 • Number of events 1 • 6 months
|
1.7%
1/59 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
3/58 • Number of events 3 • 6 months
|
0.00%
0/59 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/58 • 6 months
|
1.7%
1/59 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Shin splints
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/59 • 6 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/58 • 6 months
|
1.7%
1/59 • Number of events 1 • 6 months
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/58 • 6 months
|
1.7%
1/59 • Number of events 1 • 6 months
|
|
Cardiac disorders
Premature Ventricular Complex
|
0.00%
0/58 • 6 months
|
1.7%
1/59 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrioventricular block, 2nd degree
|
1.7%
1/58 • Number of events 1 • 6 months
|
0.00%
0/59 • 6 months
|
|
Cardiac disorders
Acute arrhythmia
|
0.00%
0/58 • 6 months
|
1.7%
1/59 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place