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Trial record 2 of 4 for:    10904452 [PUBMED-IDS]

Pilot Behavioral Support Intervention After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03092479
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Geisinger Clinic

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 20, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Difference in mean Health-Related Quality of Life (HRQoL) scores related to physical function, energy level and general health. [ 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. ]
    HRQoL 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.


Secondary Outcome Measures :
  1. Difference between groups in depression scores. [ 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. ]
    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).

  2. Difference between groups in anxiety scores. [ 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. ]
    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).

  3. Difference between groups in measured self-efficacy. [ 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. ]
    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 (WEL) scale.

  4. Difference in the degree of social adjustment between groups. [ 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. ]
    Differences in social adjustment scores between the Behavior Intervention and Control groups will be measured by comparing responses generated from the Social Adjustment scale (SAS).

  5. Difference in physical activity levels between groups. [ 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. ]
    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.

  6. Adherence to follow-up care guidelines between groups. [ Time Frame: Post-operative visit attendance and cancellations will be reviewed in the electronic medical record at the completion of the 4 month session time period. Both study groups will have visit attendance reviewed in parallel for consistency. ]
    Attendance at scheduled postoperative appointments as recorded in the electronic medical record will be compared between the Behavior Intervention and Control groups to assess differences in visit cancellation rates.

  7. Difference in emotional eating scale results between groups. [ 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. ]
    The Emotional Eating scale 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.

  8. Differences between groups in loss of eating control. [ 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. ]
    The Loss of Control Over Eating Brief Scale 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092479


Locations
United States, Pennsylvania
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

Publications:
Spielberger CD. State-trait anxiety inventory: a comprehensive bibliography. 2nd ed. Palo Alto, CA: Consulting Psychologists Press; 1989.
Edwards DW, Yarvis RM, Mueller DP, Zingale HC, Wagman WJ. Test-Taking and the Stability of Adjustment Scales Can We Assess Patient Deterioration? Evaluation Review 1978;2:275-91.
Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York: Wiley and Sons; 1987.

Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03092479     History of Changes
Other Study ID Numbers: 2016-0469
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No