Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
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
- Change in Nutritional Intake
研究概览
简要总结
The major goal of this project is to evaluate an innovative approach to obesity involving modification of the home environment. The project also will evaluate if home environment modification is more effective when supplemented with distress tolerance and related skills training.
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
- Single (Outcomes Assessor)
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
- •Have a BMI between 27 and 45 kg/m2
- •Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
- •Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits
排除标准
- •Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss
- •Are pregnant or plan to become pregnant in next 2 years
- •Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain
- •Are participating in or plan to participate in another weight loss program in the next 2 years
研究组 & 干预措施
Behavior Therapy (BT)
Active Comparator: Behavior Therapy
Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below:
Self monitoring Stimulus control Changing eating behaviors Goal setting Problem solving Social support Cognitive restructuring Relapse prevention
干预措施: Behavior Therapy for Weight Loss (Behavioral)
Behavior Therapy + Environment
Participants will receive standard behavioral therapy with an emphasis on environmental strategies.
干预措施: Behavior Therapy + Environment (Behavioral)
Acceptance-based BT + Environment
Participants will receive acceptance-based behavioral therapy with an emphasis on environmental strategies.
干预措施: Acceptance-based Behavior Therapy + Environment (Behavioral)
结局指标
主要结局
Change in Nutritional Intake
时间窗: Baseline, 12 months, 24 months
Measured by 24-hour food recall
Change in Body Weight
时间窗: Baseline, 6 months, 12 months, 18 months, 24 months
Change in Physical Activity
时间窗: Baseline, 6 months, 12 months, 18 months, 24 months
Objectively measured physical activity will be recorded at each time point.
Change in Psychosocial Status
时间窗: Baseline, 6 months, 12 months, 18 months, 24 months
次要结局
未报告次要终点