Trial of 2 TeleComputer Diet Change Maintenance Programs
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,049
- 试验地点
- 2
- 主要终点
- The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption.
研究概览
简要总结
The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. The programs will be designed to help individuals maintain a healthy diet change for a lifetime.
详细描述
RCT is completed. However, the eligibility was 18 y/o or greater and living in Greater Boston area. The participants used an evidenced based dietary intervention for 3 months and then were randomized to 1 of 3 arms. Those in the experimental arm received a 6 mo intervention based on social cognitive theory or goal systems theory. The intervention was designed to help the participants maintain previously achieved changes in the their diet, e.g., fruits and vegetables. The outcome measures are fruit and vegetable consumption as measured by servings on multiple dietary measures as well as a 24 hr dietary recall.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consume fewer than 5 fruits and vegetables per day.
- •Understand conversational English
- •Have the ability to use a telephone without assistance
排除标准
- •Under 18 years of age
- •Diagnosis of a health condition for which dietary recommendations in the would be contraindicated,
- •Have cognitive impairment
- •Have a terminal illness, recent myocardial infarction, current or former diagnosis of an eating disorder, pregnancy
- •Consume > 5 servings of fruit and vegetable per day, or
- •Plan to move away from the Boston area in less than 30 months.
结局指标
主要结局
The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption.
时间窗: July 2006-July 2009
次要结局
- Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.(July 2006-July 2009)
研究者
Robert H. Friedman
Professor of Medicine
Boston Medical Center