Weight Loss Maintenance in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of 30, or BMI of 27 with weight-related comorbidities
- •Access to a telephone and voice mail/answering machine
- •MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)
排除标准
- •Previously/currently diagnosed with an eating disorder
- •Current bi-polar, depression, substance abuse, or dependence disorder
- •Living with someone already enrolled
- •Enrolled in another weight loss program
- •Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
- •Myocardial infraction within the past three months
- •Unstable angina
- •Nephrotic syndrome/malabsorptive disease
- •Gout attack within the past year
- •Lactating/pregnant (or planning within next two years)
- •Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease
研究组 & 干预措施
MR-/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
干预措施: Weight Loss Phase (Behavioral)
MR-/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy for weight loss maintenance.
干预措施: Continued CBT (Behavioral)
MR+/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
干预措施: Weight Loss Phase (Behavioral)
MR+/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
干预措施: Continued CBT (Behavioral)
MR+/REDE-
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy and use of meal replacements for weight loss maintenance.
干预措施: continued use of meal replacements (Behavioral)
MR-/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
干预措施: Weight Loss Phase (Behavioral)
MR-/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
干预措施: Continued CBT (Behavioral)
MR-/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy as well as Reduced Energy Density Education for weight loss maintenance.
干预措施: reduced energy density education (Behavioral)
MR+/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance.
干预措施: Weight Loss Phase (Behavioral)
MR+/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance.
干预措施: Continued CBT (Behavioral)
MR+/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance.
干预措施: reduced energy density education (Behavioral)
MR+/REDE+
Weight Loss through cognitive behavioral therapy and meal replacement use, and continued therapy, as well as Reduced Energy Density Education and continued meal replacement use, for weight loss maintenance.
干预措施: continued use of meal replacements (Behavioral)
结局指标
主要结局
Weight
时间窗: baseline, 3 months, 12 months, 24 months, 36 months
次要结局
- Body composition(baseline, 3 months, 12 months, 24 months, 36 months)
- Blood work results(baseline, 3 months, 12 months, 24 months)
- Scores on questionnaire-based measures(baseline, 3 months, 12 months, 24 months, 36 months)