Trial Outcomes & Findings for Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome (NCT NCT02023515)
NCT ID: NCT02023515
Last Updated: 2017-06-27
Results Overview
Weight change from baseline to 20 weeks
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Weight change from baseline to 20 weeks
Results posted on
2017-06-27
Participant Flow
Participant milestones
| Measure |
Stress Management
Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program
|
Standard Behavioral Weight Loss
Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Programs for Weight Loss and Impact on Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
Stress Management
n=24 Participants
Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program
|
Standard Behavioral Weight Loss
n=25 Participants
Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 8.0 • n=39 Participants
|
44.0 years
STANDARD_DEVIATION 8.8 • n=41 Participants
|
45.0 years
STANDARD_DEVIATION 7.9 • n=35 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=39 Participants
|
25 participants
n=41 Participants
|
49 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Weight change from baseline to 20 weeksWeight change from baseline to 20 weeks
Outcome measures
| Measure |
Stress Management
n=24 Participants
Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program
|
Standard Behavioral Weight Loss
n=25 Participants
Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss
|
|---|---|---|
|
Weight Loss
|
1.6 kg
Standard Deviation 3.8
|
3.9 kg
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: PSS change from baseline to 20 weeksStress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers.
Outcome measures
| Measure |
Stress Management
n=24 Participants
Approximately half of the participants will be randomized to a stress management arm. Participants will undergo Emotional Brain Training during a 90 minute session once per week for ten weeks in order to rewire the brain and improve stress management techniques.
Emotional brain training: Stress management based program
|
Standard Behavioral Weight Loss
n=25 Participants
Half of participants will receive a standard behavioral weight loss program in 90 minute sessions once per week for 10 weeks
Behavioral weight loss: Standard behavioral weight loss
|
|---|---|---|
|
Decrease in Stress
|
-4.5 units on a scale
Interval -6.8 to -2.2
|
-1.8 units on a scale
Interval -4.5 to 0.9
|
Adverse Events
Stress Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Behavioral Weight Loss
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