Obesity, Weight Gain
Conditions
Keywords
Randomized controlled trial, Mindfulness, Obesity
Brief summary
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.
Interventions
BEHAVIORALMind-body lifestyle intervention
BEHAVIORALStandard lifestyle intervention
Sponsors
Center for Nutritional Research Charitable Trust
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence rate (≥70% attendance, 7 of 10 classes) | 12-weeks |
| Retention (≤25% drop-out) | 6-months |
| Willingness to participate in study (>10% of eligible) | 4-month recuitment window |
| Success meeting recruitment goals (20 patients within 3-4 months) | 4-month recruitment window |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life measured using the Medical Outcomes Study Short-Form-36 scale | 12 ± 2 weeks |
| Quality of life measured using the Impact of Weight on Quality of Life scale | 12 ± 2 weeks |
| Perceived stress measured by the Perceived Stress Scale | 12 ± 2 weeks |
| Ability to cope measured by the Brief Cope questionnaire | 12 ± 2 weeks |
| Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire | 12 ± 2 weeks |
| Depression measured by the Center for Epidemiologic Studies Depression Scale | 12 ± 2 weeks |
| Changes in body weight as measured on a digital scale | 12 ± 2 weeks post intervention-baseline |
| Eating behaviors measured using the Three Factor Eating Questionnaire | 12 ± 2 weeks |
| Eating behaviors measured using the Binge Eating Scale | 12 ± 2 weeks |
Other
| Measure | Time frame |
|---|---|
| Biomarkers of stress measured by bioassay techniques | 12 ± 2 weeks |
| Food-related attentional bias as measured by the Food-related Stroop task. | 12 ± 2 weeks |
| Biomarkers of inflammation measured by bioassay techniques | 12 ± 2 weeks |
Countries
United States
Outcome results
None listed