Weight Regain Study After Bariatric Surgery-A Pilot Project

An Evaluation of the Efficacy of a Group Treatment Intervention for Weight Regain After Bariatric Surgery-A Pilot Project

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.

Study Overview

• Status: Withdrawn
• Conditions: Weight Loss; Behavioral; Activity
• Intervention / Treatment: Behavioral: Behavioral lifestyle intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Behavioral	Behavioral: Behavioral lifestyle intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily caloric intake	Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated	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	6 months
Number of minutes of physical activity	Subjects will wear a pedometer to track their daily activity	6 months
Presence of disordered eating behaviors	Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Leslie Heinberg, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Weight Loss; Group Treatment; Weight Regain
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 13-129