Pilot Behavioral Support Intervention After Bariatric Surgery

• Sponsor: Geisinger Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03092479
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Behavioral Intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Trial of a Pilot Behavioral Support Intervention After Bariatric Surgery
• Actual Study Start Date: Jan 20, 2017
• Actual Primary Completion Date: Dec 22, 2017
• Actual Study Completion Date: Dec 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: 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.
No Intervention: Usual Care Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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

4. 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).

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geisinger Health System	Danville	Pennsylvania	United States	17822

Sponsors and Collaborators

• Geisinger Clinic

Investigators

• Principal Investigator: Laura Campbell, PhD, Geisinger Clinic
• Principal Investigator: Michelle Lent, PhD, Geisinger Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 28, 2017

More Information

Publications

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• Hirsch AG, Wood GC, Bailey-Davis L, Lent MR, Gerhard GS, Still CD. Collateral weight loss in children living with adult bariatric surgery patients: a case control study. Obesity (Silver Spring). 2014 Oct;22(10):2224-9. doi: 10.1002/oby.20827. Epub 2014 Jul 2.
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• Lent MR, Hayes SM, Wood GC, Napolitano MA, Argyropoulos G, Gerhard GS, Foster GD, Still CD. Smoking and alcohol use in gastric bypass patients. Eat Behav. 2013 Dec;14(4):460-3. doi: 10.1016/j.eatbeh.2013.08.008. Epub 2013 Aug 17.
• Lent MR, Napolitano MA, Wood GC, Argyropoulos G, Gerhard GS, Hayes S, Foster GD, Collins CA, Still CD. Internalized weight bias in weight-loss surgery patients: psychosocial correlates and weight loss outcomes. Obes Surg. 2014 Dec;24(12):2195-9. doi: 10.1007/s11695-014-1455-z.
• Lent MR, Swencionis C. Addictive personality and maladaptive eating behaviors in adults seeking bariatric surgery. Eat Behav. 2012 Jan;13(1):67-70. doi: 10.1016/j.eatbeh.2011.10.006. Epub 2011 Oct 20.
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• Livhits M, Mercado C, Yermilov I, Parikh JA, Dutson E, Mehran A, Ko CY, Gibbons MM. Preoperative predictors of weight loss following bariatric surgery: systematic review. Obes Surg. 2012 Jan;22(1):70-89. doi: 10.1007/s11695-011-0472-4. Review.
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• Mechanick JI, Youdim A, Jones DB, Garvey WT, Hurley DL, McMahon MM, Heinberg LJ, Kushner R, Adams TD, Shikora S, Dixon JB, Brethauer S; American Association of Clinical Endocrinologists; Obesity Society; American Society for Metabolic & Bariatric Surgery. Clinical practice guidelines for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient--2013 update: cosponsored by American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery. Obesity (Silver Spring). 2013 Mar;21 Suppl 1:S1-27. doi: 10.1002/oby.20461.
• Paffenbarger RS Jr, Wing AL, Hyde RT. Physical activity as an index of heart attack risk in college alumni. 1978. Am J Epidemiol. 1995 Nov 1;142(9):889-903; discussion 887-8.
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• Piette JD, Heisler M, Ganoczy D, McCarthy JF, Valenstein M. Differential medication adherence among patients with schizophrenia and comorbid diabetes and hypertension. Psychiatr Serv. 2007 Feb;58(2):207-12.
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• Responsible Party: Geisinger Clinic
• ClinicalTrials.gov Identifier: NCT03092479
• Other Study ID Numbers: 2016-0469
• First Posted: Mar 28, 2017
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Period Title: Overall Study
STARTED	24	26
COMPLETED	17	24
NOT COMPLETED	7	2

Baseline Characteristics

Arm/Group Title	Behavioral Intervention	Usual Care	Total
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.	Total of all reporting groups
Overall Participants	24	26	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.6 (9.1)	46.2 (12.0)	46.8 (10.6)
Sex: Female, Male (Count of Participants)
Female	20 83.3%	21 80.8%	41 82%
Male	4 16.7%	5 19.2%	9 18%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.2%	1 3.8%	2 4%
Not Hispanic or Latino	23 95.8%	25 96.2%	48 96%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	47.1 (6.7)	50.4 (6.2)	48.8 (6.6)
Surgery Type (participants) [Number]
RYGB	17 70.8%	16 61.5%	33 66%
SG	7 29.2%	7 26.9%	14 28%
PD/DS	0 0%	3 11.5%	3 6%
Initial Psychosocial Clearance Light (participants) [Number]
Green	13 54.2%	15 57.7%	28 56%
Yellow	11 45.8%	11 42.3%	22 44%
Months from Surgery to Enrollment (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	7.0 (3.6)	6.9 (4.1)	7.0 (3.8)
Baseline Questionnaire Scores - Quality of Life (units on a scale) [Mean (Standard Deviation) ]
SF-36 Overall	70.4 (17.9)	63.3 (18.9)	66.6 (18.6)
LOCES	11.1 (4.1)	13.0 (5.3)	12.1 (4.8)
WELSF	59.3 (15.8)	59.0 (17.4)	59.1 (16.5)
Baseline Questionnaire Scores - Mental Health (units on a scale) [Mean (Standard Deviation) ]
PHQ-9	5.5 (4.5)	7.5 (5.8)	6.5 (5.3)
STAI-S	45.0 (5.5)	44.6 (6.1)	44.8 (5.8)
STAI-T	45.7 (6.4)	45.2 (6.1)	45.4 (5.4)
Baseline Questionnaire Scores - EES (units on a scale) [Mean (Standard Deviation) ]
EES-Frustration	8.2 (8.1)	8.5 (8.8)	8.4 (8.4)
EES-Anxiety	8.4 (6.6)	6.8 (6.8)	7.6 (6.7)
EES-Depression	5.6 (3.9)	5.5 (4.8)	5.6 (4.4)
Baseline Questionnaire Scores - Diet and Exercise (units on a scale) [Mean (Standard Deviation) ]
Dietary Adherence	7.1 (1.3)	7.4 (1.2)	7.3 (1.3)
PPAQ (MVPA min/week)	120.8 (177)	82.3 (135)	100.4 (155)

Outcome Measures

1. Primary Outcome

Title	Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Measure Participants	17	24
Mean (Standard Deviation) [score on a scale]	11.4 (15.4)	4.6 (12.1)

2. Secondary Outcome

Title	Difference Between Groups in Depression Scores.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Measure Participants	17	24
Mean (Standard Deviation) [score on a scale]	-0.9 (4.6)	-1.1 (4.5)

3. Secondary Outcome

Title	Difference Between Groups in Anxiety Scores.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Measure Participants	17	24
STAI-S	0.9 (4.9)	0.3 (6.0)
STAI-T	-1.5 (4.1)	-0.4 (4.7)

4. Secondary Outcome

Title	Difference Between Groups in Measured Self-efficacy.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Measure Participants	17	24
Mean (Standard Deviation) [score on a scale]	2.0 (14.1)	-1.6 (10.9)

5. Secondary Outcome

Title	Difference in Physical Activity Levels Between Groups.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Measure Participants	17	24
Mean (Standard Deviation) [minutes (min)]	71 (160)	-14 (145)

6. Secondary Outcome

Title	Difference in Emotional Eating Scale Results Between Groups.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Measure Participants	17	24
EES-Frustration	1.5 (7.1)	0.1 (7.3)
EES-Anxiety	-0.4 (7.0)	1.9 (6.1)
EES-Depression	1.5 (4.8)	0.0 (3.8)

7. Secondary Outcome

Title	Differences Between Groups in Loss of Eating Control.
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Intervention	Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
Measure Participants	17	24
Mean (Standard Deviation) [score on a scale]	0.1 (3.9)	-0.7 (3.5)

Adverse Events

Time Frame	16 weeks during behavioral intervention or between first and final questionnaire completion for the usual care arm.
Arm/Group Title	Behavioral Intervention		Usual Care
Arm/Group Description	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 postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.
All Cause Mortality
	Behavioral Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/26 (0%)
Serious Adverse Events
	Behavioral Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/26 (0%)

Limitations/Caveats

Under- powered to detect differences between groups and limited to presenting effect sizes only. Cohort was predominantly White, limiting generalizability of our findings. Most study outcomes were self-reported, which can be subject to bias.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.