Targeting Maladaptive Eating Behaviors With Mindfulness-based Training to Prevent Weight Regain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Changes in Body Weight
研究概览
简要总结
The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.
详细描述
Specific Aim 1: Determine the effect of MORE on weight loss maintenance.
Hypothesis:
MORE will result in less weight regain compared to CON after the 8-week intervention, and benefits will be sustained after 6-month of follow-up.
Specific Aim 2:
Determine the effect of MORE on reward-related behavioral processes (e.g., disinhibition, restraint, hedonic hunger).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Age 18-65
- •Bariatric Surgery patients: 12-18 months post-operation.
- •Medical weight loss patients: patients of the bariatric weight loss clinic, weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss; stable for 3 months on medications.
- •Lifestyle weight loss: weight loss of 7% body mass via intentional weight loss within past 6 months; BMI >25 kg/m2 prior to intentional weight loss.
排除标准
- •Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; cancer treatment in past 5 years; untreated thyroid disease or other medical condition affecting weight or energy metabolism; severe food allergies; women who are pregnant, lactating, or planning pregnancy during participation in the trial; active psychiatric issues
- •Additional criteria specific to patients with history of bariatric surgery: <12 months post-op; weight regain of >5% of body mass postoperation; history of admittance to rehabilitation facility; history of post-op complications that require recent inpatient management; patients who were required to stay in the hospital >1 week post-op; revision surgery patients; heart failure patients.
结局指标
主要结局
Changes in Body Weight
时间窗: Baseline and 6 month follow up
Body weight (kg) measured using a calibrated digital scale at three time points: baseline and 6 month follow up. Outcome measure was calculated by subtracting baseline weight from 6 month weigh. Lower value indicates greater weight loss.
次要结局
- Dietary Restraint(6 month follow up)
- Ways of Savoring Checklist (WOSC).(6-month follow-up)
- Dietary Disinhibition(6 month follow-up)
- Interoceptive Awareness(6 month follow up)
- Hedonic Hunger(6 months)
研究者
Tanya Halliday
Assistant Professor
University of Utah