Telecoaching Plus a Portion Control Device for Weight Care Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index
研究概览
简要总结
The purpose of this study was to evaluate the impact of telecoaching conducted by a counselor trained in motivational interviewing paired with a portion control device for obese patients receiving care in a certified patient-centered medical home. The investigators will conduct a randomized, controlled clinical trial evaluating the effectiveness of a telecoaching intervention with a portion control device.
详细描述
The intervention will be provided during a 3-month period with follow-up through 6 months after randomization. Body mass index (BMI) and waist circumference measurements will be collected at baseline and at 6, 12, 18, and 24 weeks. Participants will also complete measures assessing eating behaviors and physical activity at baseline and at 12 and 24 weeks.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women ≥ 18 years and ≤ 55 years of age
- •A BMI of ≥ 30 and ≤ 44.9 kg/m2
- •Motivated to lose weight
- •Able to participate fully in all aspects of the study;
- •Have been provided with, understand, and have signed the informed consent.
排除标准
- •Unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia
- •A history of a gastric bypass procedure or planned gastric bypass
- •Baseline systolic blood pressure > 180 or diastolic > 100
- •Another member of their household already participating in this study
- •Current treatment with another investigational drug for obesity (within 30 days of study entry)
- •Are pregnant or lactating
- •History of anorexia or bulimia
- •Current binge eating disorder as assessed by the Patient Health Questionnaire eating disorder module (PHQ-ED)
- •Schizophrenia or bipolar disorder or have a PHQ-2 ≥ 337
- •Have been diagnosed with cancer within the past 5 years
- •Are currently participating in a program specifically to lose weight or are on a weight loss medication (last 30 days)
研究组 & 干预措施
Telecoaching plus plate
Telecoaching plus portion control plate
干预措施: Telecoaching plus Plate (Behavioral)
Usual Care
Usual Care
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change in Body Mass Index
时间窗: Baseline, 3 months and 6 months
次要结局
未报告次要终点