Morbid Obesity Clinical Trial
Official title:
A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.
The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.
Behavioral/lifestyle interventions produce acceptable success in treating moderately obese
subjects. However, their effectiveness on weight loss and maintenance in morbidly obese
subjects remains elusive.
Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen
subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty.
Subjects in the lifestyle group attended 30 behavioral modification sessions over three
years, whereas the surgery group received the standard of care nutrition. Body weight,
resting metabolic rate, physical activity, body composition measurements and dietary intake
data were assessed at standard time points during the first 3 years post-intervention.
Follow-up data on body weight and physical activity were also collected 9 years later.
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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