Weight Regain Study After Bariatric Surgery-A Pilot Project

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02754453
• Other study ID #: 13-129
• Status: Withdrawn
• Phase: N/A
• First received: September 25, 2013
• Last updated: April 25, 2016
• Start date: July 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Activity
• Behavioral
• Body Weight
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Daily caloric intake	Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated	6 months	No
Secondary	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	No
Secondary	Number of minutes of physical activity	Subjects will wear a pedometer to track their daily activity	6 months	No
Secondary	Presence of disordered eating behaviors	Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors	6 months	No