Trial Outcomes & Findings for Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults (NCT NCT02693132)
NCT ID: NCT02693132
Last Updated: 2018-11-29
Results Overview
Measured using a wearable device and by questionnaire
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks
Results posted on
2018-11-29
Participant Flow
Participant milestones
| Measure |
Supervised (SUP-PA)
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
|
Unsupervised (UNSUP-PA)
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
|
Step-based (STEP)
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
18
|
|
Overall Study
COMPLETED
|
16
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Supervised and Unsupervised Physical Activity Programs During a Weight Loss Intervention for Adults
Baseline characteristics by cohort
| Measure |
Supervised (SUP-PA)
n=17 Participants
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
|
Unsupervised (UNSUP-PA)
n=17 Participants
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
|
Step-based (STEP)
n=18 Participants
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 WeeksMeasured using a wearable device and by questionnaire
Outcome measures
| Measure |
Supervised (SUP-PA)
n=16 Participants
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
|
Unsupervised (UNSUP-PA)
n=16 Participants
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
|
Step-based (STEP)
n=17 Participants
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.
|
|---|---|---|---|
|
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)
Baseline
|
28.0 minutes/day
Standard Deviation 23.5
|
25.6 minutes/day
Standard Deviation 36.0
|
35.4 minutes/day
Standard Deviation 33.5
|
|
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)
4 Weeks
|
44.4 minutes/day
Standard Deviation 24.0
|
38.3 minutes/day
Standard Deviation 42.6
|
42.8 minutes/day
Standard Deviation 23.6
|
|
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)
8 Weeks
|
54.3 minutes/day
Standard Deviation 37.2
|
46.1 minutes/day
Standard Deviation 45.5
|
51.2 minutes/day
Standard Deviation 33.5
|
|
Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)
12 Weeks
|
49.6 minutes/day
Standard Deviation 38.7
|
41.7 minutes/day
Standard Deviation 44.5
|
47.0 minutes/day
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: Baseline (0 weeks),12 WeeksMeasured using a submaximal graded exercise test on a treadmill, with termination occurring at 85% of age-predicted maximal heart rate (computed at \[220-age\]\*0.85\]). The outcome was measures as oxygen consumption (ml/kg/min) at the point of test termination.
Outcome measures
| Measure |
Supervised (SUP-PA)
n=16 Participants
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
|
Unsupervised (UNSUP-PA)
n=16 Participants
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
|
Step-based (STEP)
n=17 Participants
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.
|
|---|---|---|---|
|
Change in Cardiorespiratory Fitness
Baseline
|
24.4 ml/kg/min
Standard Deviation 4.2
|
23.9 ml/kg/min
Standard Deviation 4.5
|
27.9 ml/kg/min
Standard Deviation 5.5
|
|
Change in Cardiorespiratory Fitness
12 Weeks
|
28.2 ml/kg/min
Standard Deviation 4.9
|
27.7 ml/kg/min
Standard Deviation 5.7
|
29.2 ml/kg/min
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline (0 weeks),12 WeeksMeasured in kilograms using a digital scale
Outcome measures
| Measure |
Supervised (SUP-PA)
n=16 Participants
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
|
Unsupervised (UNSUP-PA)
n=16 Participants
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
|
Step-based (STEP)
n=17 Participants
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.
|
|---|---|---|---|
|
Change in Body Weight
Baseline
|
84.0 kilograms
Standard Deviation 13.7
|
86.8 kilograms
Standard Deviation 13.1
|
87.7 kilograms
Standard Deviation 14.7
|
|
Change in Body Weight
12 Weeks
|
80.1 kilograms
Standard Deviation 13.2
|
81.6 kilograms
Standard Deviation 11.8
|
82.3 kilograms
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline (0 weeks),12 WeeksMeasured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA)
Outcome measures
| Measure |
Supervised (SUP-PA)
n=16 Participants
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
|
Unsupervised (UNSUP-PA)
n=16 Participants
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
|
Step-based (STEP)
n=17 Participants
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.
|
|---|---|---|---|
|
Change in Fat Mass
12 Weeks
|
30.8 kilograms
Standard Deviation 6.4
|
31.3 kilograms
Standard Deviation 8.2
|
29.6 kilograms
Standard Deviation 6.2
|
|
Change in Fat Mass
Baseline
|
34.6 kilograms
Standard Deviation 6.7
|
35.4 kilograms
Standard Deviation 7.6
|
33.7 kilograms
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline (0 weeks),12 WeeksMeasured as kcal/day using a questionnaire
Outcome measures
| Measure |
Supervised (SUP-PA)
n=14 Participants
Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff.
Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
|
Unsupervised (UNSUP-PA)
n=16 Participants
Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool.
Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
|
Step-based (STEP)
n=17 Participants
Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day.
Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day.
|
|---|---|---|---|
|
Change in Energy Intake
Baseline
|
1774 kcal/day
Standard Deviation 679
|
1773 kcal/day
Standard Deviation 922
|
1885 kcal/day
Standard Deviation 905
|
|
Change in Energy Intake
12 Weeks
|
1214 kcal/day
Standard Deviation 370
|
1342 kcal/day
Standard Deviation 438
|
1497 kcal/day
Standard Deviation 522
|
Adverse Events
Supervised (SUP-PA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unsupervised (UNSUP-PA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Step-based (STEP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place