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Weight Regain Study After Bariatric Surgery-A Pilot Project

Primary Purpose

Behavioral, Activity, Weight Loss

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral lifestyle intervention
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavioral focused on measuring Weight Regain, Group Treatment, Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Weight regain post-RYGB of at least 5 kg since reaching their weight nadir.
  • Male or Female age 18 - 65.
  • Undergone RYGB 12 - 36 month prior.
  • Ability to read, write and understand English.
  • Experienced at least a 25% total weight loss since surgery.
  • BMI at least 27 kg/m.
  • Weight regain of no more than half of excess body weight. These cases will be referred back to the surgeon.

Exclusion Criteria:

  • Taking Weight-suppressing medication (e.g. phentermine, bupropion)
  • On medications known to cause weight gain
  • Change in smoking status with past three months
  • Change in antidepressant or other psychotropic medication or dosage in past six weeks
  • Change in psychotherapy status in past six weeks
  • Current purging behaviors occurring more than once per week over the past six weeks (vomiting or laxative/diuretic use for the purpose of weight loss
  • Current alcohol abuse or dependence or illicit drug use in past three months
  • Active bipolar or psychotic spectrum disorder
  • Current suicidality or homicidality
  • Severe neuropsychological disease (history of seizure, uncontrolled hypertension
  • Condition associated with cognitive dysfunction (e.g. Alzheimer's dementia, other neurological conditions)
  • Medically unstable condition or one which the investigators feel put the participant at risk in the study
  • Functional limitations-not able to walk 2 block without assistance
  • Exercise is contra-indicated (e.g., severe cardiovascular disease, uncontrolled hypertension, hematocrit.<30%, chronic kidney disease, severe pulmonary disease

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Behavioral

Arm Description

Outcomes

Primary Outcome Measures

Weight Regain After Bariatric Surgery
The overall goal of the project is to collect pilot data for a RO1 application. The primary outcome will be kg lost and BMI units lost from pre- to post-treatment. The effect size (Mean1 - Mean2 / pooled s.d.) of the intervention will be determined for within subject and between subject differences. It is hypothesized that a moderate effect size (.5) will be demonstrated and that has been selected a priori as the criteria for pursuing a larger-scale randomized clinical trial.

Secondary Outcome Measures

Daily caloric intake
Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated
Daily protein intake
Subjects will keep a food intake diary and bring it to their appointment where daily protein intake will be calculated
Number of minutes of physical activity
Subjects will wear a pedometer to track their daily activity
Presence of disordered eating behaviors
Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors

Full Information

First Posted
September 25, 2013
Last Updated
April 25, 2016
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02754453
Brief Title
Weight Regain Study After Bariatric Surgery-A Pilot Project
Official Title
An Evaluation of the Efficacy of a Group Treatment Intervention for Weight Regain After Bariatric Surgery-A Pilot Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There are three different phases to this study: Screening phase to determine if you are eligible to participate in the study. Study phase, which will entail diet and activity, exercise and then finally self monitoring goals. End of treatment phase where you will be asked to complete questionnaires.
Detailed Description
The purpose of this study is to determine the feasibility of a group treatment program for individuals experiencing weight regain after bariatric surgery and to evaluate the effectiveness of the group treatment program. There is little information on programs to assist patients who experience weight regain after bariatric surgery. This treatment program will focus on behavioral changes and activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral, Activity, Weight Loss
Keywords
Weight Regain, Group Treatment, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Behavioral lifestyle intervention
Intervention Description
20 session lifestyle behavioral intervention with the goal of altering diet and physical activity and decreasing problematic behaviors associated with weight regain and session behavioral intervention addressing increasing physical activity, improving adherence to dietary recommendations and altering problematic eating behaviors.
Primary Outcome Measure Information:
Title
Weight Regain After Bariatric Surgery
Description
The overall goal of the project is to collect pilot data for a RO1 application. The primary outcome will be kg lost and BMI units lost from pre- to post-treatment. The effect size (Mean1 - Mean2 / pooled s.d.) of the intervention will be determined for within subject and between subject differences. It is hypothesized that a moderate effect size (.5) will be demonstrated and that has been selected a priori as the criteria for pursuing a larger-scale randomized clinical trial.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Daily caloric intake
Description
Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated
Time Frame
6 months
Title
Daily protein intake
Description
Subjects will keep a food intake diary and bring it to their appointment where daily protein intake will be calculated
Time Frame
6 months
Title
Number of minutes of physical activity
Description
Subjects will wear a pedometer to track their daily activity
Time Frame
6 months
Title
Presence of disordered eating behaviors
Description
Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Weight regain post-RYGB of at least 5 kg since reaching their weight nadir. Male or Female age 18 - 65. Undergone RYGB 12 - 36 month prior. Ability to read, write and understand English. Experienced at least a 25% total weight loss since surgery. BMI at least 27 kg/m. Weight regain of no more than half of excess body weight. These cases will be referred back to the surgeon. Exclusion Criteria: Taking Weight-suppressing medication (e.g. phentermine, bupropion) On medications known to cause weight gain Change in smoking status with past three months Change in antidepressant or other psychotropic medication or dosage in past six weeks Change in psychotherapy status in past six weeks Current purging behaviors occurring more than once per week over the past six weeks (vomiting or laxative/diuretic use for the purpose of weight loss Current alcohol abuse or dependence or illicit drug use in past three months Active bipolar or psychotic spectrum disorder Current suicidality or homicidality Severe neuropsychological disease (history of seizure, uncontrolled hypertension Condition associated with cognitive dysfunction (e.g. Alzheimer's dementia, other neurological conditions) Medically unstable condition or one which the investigators feel put the participant at risk in the study Functional limitations-not able to walk 2 block without assistance Exercise is contra-indicated (e.g., severe cardiovascular disease, uncontrolled hypertension, hematocrit.<30%, chronic kidney disease, severe pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Heinberg, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Weight Regain Study After Bariatric Surgery-A Pilot Project

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