Weight Regain Study After Bariatric Surgery-A Pilot Project

NCT ID: NCT02754453

Last Updated: 2016-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Behavioral; Activity; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral

Group Type: OTHER

Behavioral lifestyle intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Heinberg, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

13-129

Identifier Type: -

Identifier Source: org_study_id