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. 2014 Aug 8;2014(8):CD003641. doi: 10.1002/14651858.CD003641.pub4

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