Trial Outcomes & Findings for The Comparison of Energy in Take and Body Weight EXERCISE (NCT NCT01264406)
NCT ID: NCT01264406
Last Updated: 2025-01-07
Results Overview
A comparison of three groups for the effects of energy balance: 1. Healthy Living, 2. Recommended dose exercise, and 3. High dose exercise. Random assignment is determined by chance. Healthy Living Group: Information tips on a variety of topics, including stress management, the benefits of eating fruits and vegetables, and other health related matters. This information is sent directly to your cell phone or email address throughout the study. Encouragements are sent to attend monthly seminars on various health topics at Pennington. Maintain a baseline level of exercise throughout the study. Recommended Dose Exercise: 3 t0 4 low-intensity sessions per week, each lasting about 30 minutes, at Pennington Fitness and Wellness Center. All exercise will be done on a treadmill. High Dose Exercise: 4 to 5 high-intensity session s per week, each lasting about 50-70 minutes, at Pennington Fitness and wellness center. All exercise will be done on the treadmill.
COMPLETED
198 participants
6 months after screening
2025-01-07
Participant Flow
Participant milestones
| Measure |
Exercise Group (20 KKW)
Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
|
Exercise Group (8 KKW)
One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes
|
Control Group
This group will be instructed to maintain their baseline level of exercise.
|
|---|---|---|---|
|
Overall Study
STARTED
|
67
|
66
|
65
|
|
Overall Study
COMPLETED
|
51
|
59
|
61
|
|
Overall Study
NOT COMPLETED
|
16
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Comparison of Energy in Take and Body Weight EXERCISE
Baseline characteristics by cohort
| Measure |
Exercise Group (20 KKW)
n=51 Participants
Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
|
Exercise Group (8 KKW)
n=59 Participants
One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes
|
Control Group
n=61 Participants
This group will be instructed to maintain their baseline level of exercise.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months after screeningA comparison of three groups for the effects of energy balance: 1. Healthy Living, 2. Recommended dose exercise, and 3. High dose exercise. Random assignment is determined by chance. Healthy Living Group: Information tips on a variety of topics, including stress management, the benefits of eating fruits and vegetables, and other health related matters. This information is sent directly to your cell phone or email address throughout the study. Encouragements are sent to attend monthly seminars on various health topics at Pennington. Maintain a baseline level of exercise throughout the study. Recommended Dose Exercise: 3 t0 4 low-intensity sessions per week, each lasting about 30 minutes, at Pennington Fitness and Wellness Center. All exercise will be done on a treadmill. High Dose Exercise: 4 to 5 high-intensity session s per week, each lasting about 50-70 minutes, at Pennington Fitness and wellness center. All exercise will be done on the treadmill.
Outcome measures
| Measure |
Exercise Group (20 KKW)
n=51 Participants
Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
|
Exercise Group (8 KKW)
n=59 Participants
One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes
|
Control Group
n=61 Participants
This group will be instructed to maintain their baseline level of exercise.
|
|---|---|---|---|
|
A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW]
|
123.6 kcal/day
Interval 64.5 to 182.7
|
90.7 kcal/day
Interval 35.1 to 146.4
|
-2.3 kcal/day
Interval -58.0 to 53.5
|
Adverse Events
Exercise Group (20 KKW)
Exercise Group (8 KKW)
Control Group
Serious adverse events
| Measure |
Exercise Group (20 KKW)
n=67 participants at risk
Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
|
Exercise Group (8 KKW)
n=66 participants at risk
One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes
|
Control Group
n=65 participants at risk
This group will be instructed to maintain their baseline level of exercise.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
pelvis fracture
|
0.00%
0/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Psychiatric disorders
global amnesia
|
0.00%
0/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Vascular disorders
venous engorgement and orbital swelling
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
1.5%
1/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Reproductive system and breast disorders
prostate biopsy positive for malignant cells
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
Other adverse events
| Measure |
Exercise Group (20 KKW)
n=67 participants at risk
Exercise group will obtain 20 KKW, perform in 4-5 sessions per week for approximately 50-70 minutes per session.
|
Exercise Group (8 KKW)
n=66 participants at risk
One exercise group will obtain 8KKW (kcal/kg/week) over 3-4 sessions per wee, which will result in each session lasting approximately 30 minutes
|
Control Group
n=65 participants at risk
This group will be instructed to maintain their baseline level of exercise.
|
|---|---|---|---|
|
Infections and infestations
sinus infection/URI
|
7.5%
5/67
|
9.1%
6/66
|
0.00%
0/65
|
|
Surgical and medical procedures
basal cell carcinoma removed from ear
|
0.00%
0/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Surgical and medical procedures
rotator cuff repair
|
0.00%
0/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
motor vehicle collision
|
0.00%
0/67
|
3.0%
2/66
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
foot pain
|
1.5%
1/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
pelvic and pudenda pain
|
0.00%
0/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Renal and urinary disorders
urinary incontinence
|
0.00%
0/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Surgical and medical procedures
laprascopic myomectomy
|
0.00%
0/67
|
1.5%
1/66
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
bone fracture
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
fell down stairs at work
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
pain from degenerative disk disease
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
|
Cardiac disorders
acute chest pain
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
|
Nervous system disorders
migraine headaches
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
light headed and hypotensive
|
1.5%
1/67
|
0.00%
0/66
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
skin abrasions from EKG leads
|
0.00%
0/67
|
0.00%
0/66
|
1.5%
1/65
|
|
Injury, poisoning and procedural complications
knee sprain
|
0.00%
0/67
|
0.00%
0/66
|
1.5%
1/65
|
|
Gastrointestinal disorders
ER visit
|
0.00%
0/67
|
0.00%
0/66
|
1.5%
1/65
|
|
Renal and urinary disorders
kidney stones
|
0.00%
0/67
|
0.00%
0/66
|
1.5%
1/65
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
intra-abdominal mass found
|
0.00%
0/67
|
0.00%
0/66
|
1.5%
1/65
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place