Weight Regain Study After Bariatric Surgery-A Pilot Project

NeuroTherapia, Inc.

Status

Withdrawn

Conditions

Weight Loss

Behavioral

Activity

Treatments

Behavioral: Behavioral lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02754453

13-129

Details and patient eligibility

About

There are three different phases to this study:

Screening phase to determine if you are eligible to participate in the study.
Study phase, which will entail diet and activity, exercise and then finally self monitoring goals.
End of treatment phase where you will be asked to complete questionnaires.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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