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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.