Weight Regain Study After Bariatric Surgery-A Pilot Project

Withdrawn before enrolling · Not applicable

Conditions studied: Behavioral, Activity, Weight Loss

In brief

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.

Key facts

Study ID

NCT02754453

Run by

The Cleveland Clinic

People needed

0

Starts

2013-07-01

Expected to finish

2015-10-01

Last updated by the study team

2016-04-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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