Weight Regain Study After Bariatric Surgery-A Pilot Project
- Conditions
- ActivityBehavioralWeight Loss
- Interventions
- Behavioral: Behavioral lifestyle intervention
- Registration Number
- NCT02754453
- Lead Sponsor
- The Cleveland Clinic
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Behavioral Behavioral lifestyle intervention -
- Primary Outcome Measures
Name Time Method Weight Regain After Bariatric Surgery 6 months 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
Name Time Method Daily caloric intake 6 months Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated
Daily protein intake 6 months 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 6 months Subjects will wear a pedometer to track their daily activity
Presence of disordered eating behaviors 6 months Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors
Trial Locations
- Locations (1)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States