NCT01929850.
Trial name or title | Not reported |
Methods | RCT, cross‐over design |
Participants | Female; of a medically underserved, rural, poor or under‐represented minority (based on specified criteria); history of obesity at least 2.5 years; BMI > 40 and < 55, or BMI > 35 and <55 with one or more significant comorbidities (defined as diabetes, pulmonary disease, cardiac disease, or hypertension). |
Interventions | Laparoscopic sleeve gastrectomy Intensive medically supervised nutritional and exercise therapy ('Weight Watchers 360') |
Outcomes | Proposed assessment at 12 months: BMI (primary outcome). Quality of life (instrument(s) not reported). |
Starting date | October 2013; estimated completion date October 2018 |
Contact information | John P Cello, MD, University of California, San Francisco / San Francisco General Hospital, California, United States |
Study identifier | NCT01929850 |
Official title | Bariatric Surgery Plus Weight Watchers vs. Weight Watchers in Underserved Minorities: Randomized Controlled Cross‐over Trial |
Stated purpose of study | Not explicitly stated |
Notes | Estimated enrolment 100 |
BMI: body mass index RCT: randomised controlled trial SF‐36: Short form 36