Trial Outcomes & Findings for Pilot Behavioral Support Intervention After Bariatric Surgery (NCT NCT03092479)
NCT ID: NCT03092479
Last Updated: 2020-03-16
Results Overview
Health-Related Quality of Life emotional scale scores will be assessed by the SF-36-Item Short Form Health Survey between the Behavior Intervention and Control groups. This study seeks a difference of 2/3 standard deviation in scores between groups for statistical significance. Range 0-100. Higher score indicates a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.
Results posted on
2020-03-16
Participant Flow
Participant milestones
| Measure |
Behavioral Intervention
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Behavioral Intervention
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Pilot Behavioral Support Intervention After Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Behavioral Intervention
n=24 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=26 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.6 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
46.2 years
STANDARD_DEVIATION 12.0 • n=107 Participants
|
46.8 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
47.1 kg/m^2
STANDARD_DEVIATION 6.7 • n=99 Participants
|
50.4 kg/m^2
STANDARD_DEVIATION 6.2 • n=107 Participants
|
48.8 kg/m^2
STANDARD_DEVIATION 6.6 • n=206 Participants
|
|
Surgery Type
RYGB
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Surgery Type
SG
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Surgery Type
PD/DS
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Initial Psychosocial Clearance Light
Green
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Initial Psychosocial Clearance Light
Yellow
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Months from Surgery to Enrollment
|
7.0 Months
STANDARD_DEVIATION 3.6 • n=99 Participants
|
6.9 Months
STANDARD_DEVIATION 4.1 • n=107 Participants
|
7.0 Months
STANDARD_DEVIATION 3.8 • n=206 Participants
|
|
Baseline Questionnaire Scores - Quality of Life
SF-36 Overall
|
70.4 units on a scale
STANDARD_DEVIATION 17.9 • n=99 Participants
|
63.3 units on a scale
STANDARD_DEVIATION 18.9 • n=107 Participants
|
66.6 units on a scale
STANDARD_DEVIATION 18.6 • n=206 Participants
|
|
Baseline Questionnaire Scores - Quality of Life
LOCES
|
11.1 units on a scale
STANDARD_DEVIATION 4.1 • n=99 Participants
|
13.0 units on a scale
STANDARD_DEVIATION 5.3 • n=107 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 4.8 • n=206 Participants
|
|
Baseline Questionnaire Scores - Quality of Life
WELSF
|
59.3 units on a scale
STANDARD_DEVIATION 15.8 • n=99 Participants
|
59.0 units on a scale
STANDARD_DEVIATION 17.4 • n=107 Participants
|
59.1 units on a scale
STANDARD_DEVIATION 16.5 • n=206 Participants
|
|
Baseline Questionnaire Scores - Mental Health
PHQ-9
|
5.5 units on a scale
STANDARD_DEVIATION 4.5 • n=99 Participants
|
7.5 units on a scale
STANDARD_DEVIATION 5.8 • n=107 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Baseline Questionnaire Scores - Mental Health
STAI-S
|
45.0 units on a scale
STANDARD_DEVIATION 5.5 • n=99 Participants
|
44.6 units on a scale
STANDARD_DEVIATION 6.1 • n=107 Participants
|
44.8 units on a scale
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Baseline Questionnaire Scores - Mental Health
STAI-T
|
45.7 units on a scale
STANDARD_DEVIATION 6.4 • n=99 Participants
|
45.2 units on a scale
STANDARD_DEVIATION 6.1 • n=107 Participants
|
45.4 units on a scale
STANDARD_DEVIATION 5.4 • n=206 Participants
|
|
Baseline Questionnaire Scores - EES
EES-Frustration
|
8.2 units on a scale
STANDARD_DEVIATION 8.1 • n=99 Participants
|
8.5 units on a scale
STANDARD_DEVIATION 8.8 • n=107 Participants
|
8.4 units on a scale
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Baseline Questionnaire Scores - EES
EES-Anxiety
|
8.4 units on a scale
STANDARD_DEVIATION 6.6 • n=99 Participants
|
6.8 units on a scale
STANDARD_DEVIATION 6.8 • n=107 Participants
|
7.6 units on a scale
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
Baseline Questionnaire Scores - EES
EES-Depression
|
5.6 units on a scale
STANDARD_DEVIATION 3.9 • n=99 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 4.8 • n=107 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 4.4 • n=206 Participants
|
|
Baseline Questionnaire Scores - Diet and Exercise
Dietary Adherence
|
7.1 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 1.2 • n=107 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Baseline Questionnaire Scores - Diet and Exercise
PPAQ (MVPA min/week)
|
120.8 units on a scale
STANDARD_DEVIATION 177 • n=99 Participants
|
82.3 units on a scale
STANDARD_DEVIATION 135 • n=107 Participants
|
100.4 units on a scale
STANDARD_DEVIATION 155 • n=206 Participants
|
PRIMARY outcome
Timeframe: Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.Health-Related Quality of Life emotional scale scores will be assessed by the SF-36-Item Short Form Health Survey between the Behavior Intervention and Control groups. This study seeks a difference of 2/3 standard deviation in scores between groups for statistical significance. Range 0-100. Higher score indicates a better outcome.
Outcome measures
| Measure |
Behavioral Intervention
n=17 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=24 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health.
|
11.4 score on a scale
Standard Deviation 15.4
|
4.6 score on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.Difference in depression scores between the Behavior Intervention and Control groups will be measured using the total score generated from the Patient Health Questionnaire (PHQ-9). Range is 0-27. Higher score means a worse outcome.
Outcome measures
| Measure |
Behavioral Intervention
n=17 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=24 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Difference Between Groups in Depression Scores.
|
-0.9 score on a scale
Standard Deviation 4.6
|
-1.1 score on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.Difference in anxiety weighted scores between the Behavior Intervention and Control groups will be measured using the scores generated from the State-Trait Anxiety Inventory (STAI) and is scored on a four-point Likert scale. Range is 20-80 per subtest. Higher scores indicate a worse outcome.
Outcome measures
| Measure |
Behavioral Intervention
n=17 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=24 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Difference Between Groups in Anxiety Scores.
STAI-S
|
0.9 units on a scale
Standard Deviation 4.9
|
0.3 units on a scale
Standard Deviation 6.0
|
|
Difference Between Groups in Anxiety Scores.
STAI-T
|
-1.5 units on a scale
Standard Deviation 4.1
|
-0.4 units on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.Difference in self-efficacy parameters between the Behavior Intervention and Control groups will be measured by comparing responses generated from the Weight Efficacy Life-Style short-form scale (WEL-SF). Range is 0-80. Higher score indicates a better outcome
Outcome measures
| Measure |
Behavioral Intervention
n=17 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=24 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Difference Between Groups in Measured Self-efficacy.
|
2.0 score on a scale
Standard Deviation 14.1
|
-1.6 score on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.Differences in physical activity levels between the Behavior Intervention and Control groups will be measured by comparing hours per day spent in vigorous, moderate, light or sitting activity as recorded on the Paffenbarger Physical Activity Questionnaire (PPAQ). Calculated by minutes per week of Moderate to Vigorous Activity (MVPA).
Outcome measures
| Measure |
Behavioral Intervention
n=17 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=24 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Difference in Physical Activity Levels Between Groups.
|
71 minutes (min)
Standard Deviation 160
|
-14 minutes (min)
Standard Deviation 145
|
SECONDARY outcome
Timeframe: Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.The Emotional Eating scale (EES) measures a subject's desire to eat in response to an emotional stimulus. This scale will be used to assess differences in emotional eating habits between the Behavior Intervention and Control groups. Subscale scores range 0-36 or 0-44. Higher scores indicates worse outcome.
Outcome measures
| Measure |
Behavioral Intervention
n=17 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=24 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Difference in Emotional Eating Scale Results Between Groups.
EES-Frustration
|
1.5 score on a scale
Standard Deviation 7.1
|
0.1 score on a scale
Standard Deviation 7.3
|
|
Difference in Emotional Eating Scale Results Between Groups.
EES-Anxiety
|
-0.4 score on a scale
Standard Deviation 7.0
|
1.9 score on a scale
Standard Deviation 6.1
|
|
Difference in Emotional Eating Scale Results Between Groups.
EES-Depression
|
1.5 score on a scale
Standard Deviation 4.8
|
0.0 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.The Loss of Control Over Eating Scale-Brief (LOCES) provides a 5 point scoring system to assess subject's loss of eating control. This scale will be used to assess differences in this measure between the Behavior Intervention and Control groups. Range is 5-35. Higher score indicates a worse outcome.
Outcome measures
| Measure |
Behavioral Intervention
n=17 Participants
4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
Behavioral Intervention: Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
|
Usual Care
n=24 Participants
Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
|
|---|---|---|
|
Differences Between Groups in Loss of Eating Control.
|
0.1 score on a scale
Standard Deviation 3.9
|
-0.7 score on a scale
Standard Deviation 3.5
|
Adverse Events
Behavioral Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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