Clinical trial NCT02754453: Weight Regain Study After Bariatric Surgery-A Pilot Project
Official title: An Evaluation of the Efficacy of a Group Treatment Intervention for Weight Regain After Bariatric Surgery-A Pilot Project
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Behavioral
Activity
Weight Loss
Keywords: Weight Regain
Group Treatment
Weight Loss
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight Regain After Bariatric Surgery
timeFrame: 6 months
Secondary outcomes:
measure: Daily caloric intake
timeFrame: 6 months
measure: Daily protein intake
timeFrame: 6 months
measure: Number of minutes of physical activity
timeFrame: 6 months
measure: Presence of disordered eating behaviors
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Leslie Heinberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: