A Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/4/2017 |
| Start Date: | March 2014 |
| End Date: | October 2014 |
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.
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.
Inclusion Criteria:
1. Patients who have undergone bariatric surgery 1-5 years prior to study start (by
medical record and/or self report)
2. Weight loss plateau (< 5 lbs weight loss in past month) (by medical report and/or
self report)
3. Ages 18-65 years (by medical record and/or self report)
4. Able to complete outcome assessments
Exclusion Criteria:
1. Prior experience with meditation course (past 6 months), current
mindfulness/meditation practice, or regular meditation or mindfulness practice in
past year ("Regular practice" defined as practicing formally 1 or more times a week
for 2 months).
2. Plans to leave the study area within next 12 months
3. Serious psychiatric illness or personality disorder (by medical record and/or
self-report)
4. Current alcohol and/or substance abuse
5. Pregnancy or plans to become pregnant in next year
6. Non-English speaking
7. > 1 prior weight loss surgery (by medical record and self-report)
8. Gastric band removed prior to study contact.
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