Pilot Behavioral Support Intervention After Bariatric Surgery

March 2, 2020 updated by: Geisinger Clinic

A Randomized Trial of a Pilot Behavioral Support Intervention After Bariatric Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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). Range is 0-27. Higher score means a worse outcome.
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 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) and is scored on a four-point Likert scale. Range is 20-80 per subtest. Higher scores indicate a worse outcome.
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 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 short-form scale (WEL-SF). Range is 0-80. Higher score indicates a better outcome
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 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 (PPAQ). Calculated by minutes per week of Moderate to Vigorous Activity (MVPA).
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 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 (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.
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 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 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2017

Primary Completion (Actual)

December 22, 2017

Study Completion (Actual)

December 22, 2017

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-0469

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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