Obesity Clinical Trial
Official title:
A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
This randomized controlled trial is designed to test the feasibility and efficacy of a novel
10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and
psychosocial outcomes in patients who have undergone bariatric surgery.
Primary hypothesis:
Bariatric patients who have stopped losing weight (< 5 lbs weight loss in past month) 1-5
years post-surgery will be willing to participate in this 10-week intervention. The
investigators expect a high adherence rate (>70%) and no issues with meeting recruitment
goals.
Secondary hypotheses:
Patients assigned to the MBI will show greater improvement in a) weight control (defined by
differences in body weight between baseline and follow-up); b) eating behaviors (binge
eating, emotional eating); and c) psychosocial measures (quality of life, depression,
perceived stress, eating self-efficacy, coping ability) than a standard lifestyle
intervention (1 hr lifestyle counseling).
Patients assigned to the MBI intervention will show greater improvement in biomarkers of
stress and inflammation [salivary cortisol, high sensitivity C-reactive protein (hs-CRP),
interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)] as compared with a
standard lifestyle intervention.
Food-related attentional bias as measured by the food-related Stroop task will be
differentially affected among patients assigned to the MBI as compared with the intensive
lifestyle intervention and standard lifestyle intervention.
n/a
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