There are three different phases to this study: 1. Screening phase to determine if you are eligible to participate in the study. 2. Study phase, which will entail diet and activity, exercise and then finally self monitoring goals. 3. End of treatment phase where you will be asked to complete questionnaires.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Cleveland Clinic Foundation
Cleveland, Ohio, United States
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.
Time frame: 6 months
Daily caloric intake
Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated
Time frame: 6 months
Daily protein intake
Subjects will keep a food intake diary and bring it to their appointment where daily protein intake will be calculated
Time frame: 6 months
Number of minutes of physical activity
Subjects will wear a pedometer to track their daily activity
Time frame: 6 months
Presence of disordered eating behaviors
Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors
Time frame: 6 months
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