A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Willingness to participate in study (>10% of eligible)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone bariatric surgery 1-5 years prior to study start (by medical record and/or self report)
- •Weight loss plateau (< 5 lbs weight loss in past month) (by medical report and/or self report)
- •Ages 18-65 years (by medical record and/or self report)
- •Able to complete outcome assessments
排除标准
- •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).
- •Plans to leave the study area within next 12 months
- •Serious psychiatric illness or personality disorder (by medical record and/or self-report)
- •Current alcohol and/or substance abuse
- •Pregnancy or plans to become pregnant in next year
- •Non-English speaking
- •> 1 prior weight loss surgery (by medical record and self-report)
- •Gastric band removed prior to study contact.
结局指标
主要结局
Willingness to participate in study (>10% of eligible)
时间窗: 4-month recuitment window
Adherence rate (≥70% attendance, 7 of 10 classes)
时间窗: 12-weeks
Retention (≤25% drop-out)
时间窗: 6-months
Success meeting recruitment goals (20 patients within 3-4 months)
时间窗: 4-month recruitment window
次要结局
- Eating behaviors measured using the Three Factor Eating Questionnaire(12 ± 2 weeks)
- Changes in body weight as measured on a digital scale(12 ± 2 weeks post intervention-baseline)
- Eating behaviors measured using the Binge Eating Scale(12 ± 2 weeks)
- Quality of life measured using the Impact of Weight on Quality of Life scale(12 ± 2 weeks)
- Depression measured by the Center for Epidemiologic Studies Depression Scale(12 ± 2 weeks)
- Ability to cope measured by the Brief Cope questionnaire(12 ± 2 weeks)
- Quality of life measured using the Medical Outcomes Study Short-Form-36 scale(12 ± 2 weeks)
- Perceived stress measured by the Perceived Stress Scale(12 ± 2 weeks)
- Eating self-efficacy measured by the Weight Efficacy Lifestyle Questionnaire(12 ± 2 weeks)
研究者
Christina Wee
Principal Investigator
Beth Israel Deaconess Medical Center