Weight Regain Study After Bariatric Surgery-A Pilot Project (NCT02754453) | Clinical Trial Compass
WithdrawnNot Applicable
Weight Regain Study After Bariatric Surgery-A Pilot Project
Stopped: No funding
United States0Started 2013-07
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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, uncontrol…