Obesity
Conditions
Brief summary
Prospective, randomized pilot trial to evaluate a comprehensive postoperative behavioral support intervention using a 4-month bi-weekly program in 40 bariatric surgery patients (all surgical procedure types) from the Geisinger Health System Center for Nutrition and Weight Management compared to 40 usual care patients.
Detailed description
Bariatric surgery patients may experience significant psychosocial changes after surgery, but little psychological support is available beyond support groups postoperatively. Psychosocial changes after surgery, including mood fluctuations, interpersonal issues and substance use, have the potential to lower quality of life and interfere with adherence to the postoperative diet and lifestyle, diminishing weight loss outcomes. This prospective randomized pilot trial will evaluate the effect of a postoperative support program targeting quality of life, psychosocial functioning and adherence to behavior change in Geisinger Health System (GHS) bariatric surgery patients. In this study there will be two arms. The intervention arm will include forty bariatric surgery patients (all procedure types) from the GHS Center for Nutrition and Weight Management (CNWM) who will participate in a four month bi-weekly postoperative behavioral support program to address psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain. The control arm will include 40 usual care (UC) patients from the same center that completed bariatric surgery within one year. Both groups will complete two sets of surveys. The first set will be administered at study initiation. The second set will be administered upon completion of the 8 sessions for the intervention group. The control group will also complete surveys during this same timeframe (approximately 4-6 months after baseline survey completion). Upon study completion, control group members will be afforded an opportunity to participate in the same postoperative behavioral support program offered to the intervention group. The primary endpoint of this study will be quality of life with secondary endpoints including differences in psychosocial functioning (mood, eating behaviors) and adherence (diet, physical activity, appointments) as well as patient satisfaction, treatment feasibility and attrition.
Interventions
BEHAVIORALBehavioral 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.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI\>35 kg/m2 at time of surgery * Primary bariatric surgery completion \< 1 year * Understanding of informed consent
Exclusion criteria
* Pregnancy * Revision of bariatric surgery * Significant cognitive impairment that prevents informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Groups in Anxiety Scores. | 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. |
| Difference Between Groups in Measured Self-efficacy. | 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 |
| Difference Between Groups in Depression Scores. | 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. |
| Difference in Emotional Eating Scale Results Between Groups. | 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. |
| Differences Between Groups in Loss of Eating Control. | 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. |
| Difference in Physical Activity Levels Between Groups. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Usual Care Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines. | 26 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Total | Behavioral Intervention |
|---|---|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 12 | 46.8 years STANDARD_DEVIATION 10.6 | 47.6 years STANDARD_DEVIATION 9.1 |
| Baseline Questionnaire Scores - Diet and Exercise Dietary Adherence | 7.4 units on a scale STANDARD_DEVIATION 1.2 | 7.3 units on a scale STANDARD_DEVIATION 1.3 | 7.1 units on a scale STANDARD_DEVIATION 1.3 |
| Baseline Questionnaire Scores - Diet and Exercise PPAQ (MVPA min/week) | 82.3 units on a scale STANDARD_DEVIATION 135 | 100.4 units on a scale STANDARD_DEVIATION 155 | 120.8 units on a scale STANDARD_DEVIATION 177 |
| Baseline Questionnaire Scores - EES EES-Anxiety | 6.8 units on a scale STANDARD_DEVIATION 6.8 | 7.6 units on a scale STANDARD_DEVIATION 6.7 | 8.4 units on a scale STANDARD_DEVIATION 6.6 |
| Baseline Questionnaire Scores - EES EES-Depression | 5.5 units on a scale STANDARD_DEVIATION 4.8 | 5.6 units on a scale STANDARD_DEVIATION 4.4 | 5.6 units on a scale STANDARD_DEVIATION 3.9 |
| Baseline Questionnaire Scores - EES EES-Frustration | 8.5 units on a scale STANDARD_DEVIATION 8.8 | 8.4 units on a scale STANDARD_DEVIATION 8.4 | 8.2 units on a scale STANDARD_DEVIATION 8.1 |
| Baseline Questionnaire Scores - Mental Health PHQ-9 | 7.5 units on a scale STANDARD_DEVIATION 5.8 | 6.5 units on a scale STANDARD_DEVIATION 5.3 | 5.5 units on a scale STANDARD_DEVIATION 4.5 |
| Baseline Questionnaire Scores - Mental Health STAI-S | 44.6 units on a scale STANDARD_DEVIATION 6.1 | 44.8 units on a scale STANDARD_DEVIATION 5.8 | 45.0 units on a scale STANDARD_DEVIATION 5.5 |
| Baseline Questionnaire Scores - Mental Health STAI-T | 45.2 units on a scale STANDARD_DEVIATION 6.1 | 45.4 units on a scale STANDARD_DEVIATION 5.4 | 45.7 units on a scale STANDARD_DEVIATION 6.4 |
| Baseline Questionnaire Scores - Quality of Life LOCES | 13.0 units on a scale STANDARD_DEVIATION 5.3 | 12.1 units on a scale STANDARD_DEVIATION 4.8 | 11.1 units on a scale STANDARD_DEVIATION 4.1 |
| Baseline Questionnaire Scores - Quality of Life SF-36 Overall | 63.3 units on a scale STANDARD_DEVIATION 18.9 | 66.6 units on a scale STANDARD_DEVIATION 18.6 | 70.4 units on a scale STANDARD_DEVIATION 17.9 |
| Baseline Questionnaire Scores - Quality of Life WELSF | 59.0 units on a scale STANDARD_DEVIATION 17.4 | 59.1 units on a scale STANDARD_DEVIATION 16.5 | 59.3 units on a scale STANDARD_DEVIATION 15.8 |
| Body Mass Index (BMI) | 50.4 kg/m^2 STANDARD_DEVIATION 6.2 | 48.8 kg/m^2 STANDARD_DEVIATION 6.6 | 47.1 kg/m^2 STANDARD_DEVIATION 6.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 48 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Initial Psychosocial Clearance Light Green | 15 participants | 28 participants | 13 participants |
| Initial Psychosocial Clearance Light Yellow | 11 participants | 22 participants | 11 participants |
| Months from Surgery to Enrollment | 6.9 Months STANDARD_DEVIATION 4.1 | 7.0 Months STANDARD_DEVIATION 3.8 | 7.0 Months STANDARD_DEVIATION 3.6 |
| Sex: Female, Male Female | 21 Participants | 41 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
| Surgery Type PD/DS | 3 participants | 3 participants | 0 participants |
| Surgery Type RYGB | 16 participants | 33 participants | 17 participants |
| Surgery Type SG | 7 participants | 14 participants | 7 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
Primary
Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health.
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Intervention | 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 |
| Usual Care | Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health. | 4.6 score on a scale | Standard Deviation 12.1 |
Secondary
Difference Between Groups in Anxiety Scores.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Intervention | Difference Between Groups in Anxiety Scores. | STAI-T | -1.5 units on a scale | Standard Deviation 4.1 |
| Behavioral Intervention | Difference Between Groups in Anxiety Scores. | STAI-S | 0.9 units on a scale | Standard Deviation 4.9 |
| Usual Care | Difference Between Groups in Anxiety Scores. | STAI-S | 0.3 units on a scale | Standard Deviation 6 |
| Usual Care | Difference Between Groups in Anxiety Scores. | STAI-T | -0.4 units on a scale | Standard Deviation 4.7 |
Secondary
Difference Between Groups in Depression Scores.
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Intervention | Difference Between Groups in Depression Scores. | -0.9 score on a scale | Standard Deviation 4.6 |
| Usual Care | Difference Between Groups in Depression Scores. | -1.1 score on a scale | Standard Deviation 4.5 |
Secondary
Difference Between Groups in Measured Self-efficacy.
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Intervention | Difference Between Groups in Measured Self-efficacy. | 2.0 score on a scale | Standard Deviation 14.1 |
| Usual Care | Difference Between Groups in Measured Self-efficacy. | -1.6 score on a scale | Standard Deviation 10.9 |
Secondary
Difference in Emotional Eating Scale Results Between Groups.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Intervention | Difference in Emotional Eating Scale Results Between Groups. | EES-Frustration | 1.5 score on a scale | Standard Deviation 7.1 |
| Behavioral Intervention | Difference in Emotional Eating Scale Results Between Groups. | EES-Anxiety | -0.4 score on a scale | Standard Deviation 7 |
| Behavioral Intervention | Difference in Emotional Eating Scale Results Between Groups. | EES-Depression | 1.5 score on a scale | Standard Deviation 4.8 |
| Usual Care | Difference in Emotional Eating Scale Results Between Groups. | EES-Frustration | 0.1 score on a scale | Standard Deviation 7.3 |
| Usual Care | Difference in Emotional Eating Scale Results Between Groups. | EES-Anxiety | 1.9 score on a scale | Standard Deviation 6.1 |
| Usual Care | Difference in Emotional Eating Scale Results Between Groups. | EES-Depression | 0.0 score on a scale | Standard Deviation 3.8 |
Secondary
Difference in Physical Activity Levels Between Groups.
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Intervention | Difference in Physical Activity Levels Between Groups. | 71 minutes (min) | Standard Deviation 160 |
| Usual Care | Difference in Physical Activity Levels Between Groups. | -14 minutes (min) | Standard Deviation 145 |
Secondary
Differences Between Groups in Loss of Eating Control.
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Intervention | Differences Between Groups in Loss of Eating Control. | 0.1 score on a scale | Standard Deviation 3.9 |
| Usual Care | Differences Between Groups in Loss of Eating Control. | -0.7 score on a scale | Standard Deviation 3.5 |