Portion Size Strategies for Management of Body Weight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
The primary aim of this research is to determine the efficacy of two portion-control strategies to achieve sustainable dietary and behavior changes and to promote weight loss and maintenance. A randomized controlled trial will test two approaches to managing portion sizes: one that gives individuals skills and tools to help them make appropriate portion choices, and another that focuses on consumption of pre-portioned foods in order to limit exposure to large portions in the personal food environment. A third group will receive a basic nutritional program to promote weight loss.
The second aim of the research is to determine the effects of the programs on knowledge and consumption of appropriate portions, as assessed by innovative assessment methods and multiple-pass dietary recalls. The third aim is to conduct exploratory analyses of individual factors that may influence the response to the portion-control interventions, such as psychosocial indicators, blood biomarkers, and measures of adherence to the interventions. The expected outcome of the project is that it will lead to the development of specific, evidence-based strategies to help control portion sizes in order to manage weight.
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
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index of 28 to 45 kg/m squared
- •Able to safely engage in physical activity (walking)
- •Able to attend regular instructional sessions at University Park, Pennsylvania
排除标准
- •have a medical condition diagnosed by a physician that precludes participation
- •report symptoms indicative of depression or disordered eating
- •report serious food allergies or intolerance
- •current or planned participation in a weight-loss program
- •pregnant or lactating or planning to become pregnant in the next 18 months
结局指标
主要结局
Change in body weight
时间窗: Months 0 to 12
Body weight will be measured at multiple time points during the 12-month trial; the main outcome will be the weight trajectory across this time
次要结局
- Change in waist circumference(Months 0, 3, 6, & 12)
- Change in portion size selection, perception, and knowledge(Months 0, 3, 6, & 12)
- Change in portion size consumption(Months 0, 3, 6, & 12)
- Change in blood biomarkers(Months 0, 3, 6, & 12)
- Change in blood pressure(Months 0, 3, 6, & 12)
- Change in dietary intakes(Months 0, 3, 6, 9, & 12)
- Change in step counts(Months 0, 3, 6, 9, & 12)
- Change in attitudes and behaviors related to food and eating(Months 0, 1, 3, 6, & 12)
- Change in psychosocial characteristics(Months 0, 3, 6, & 12)
- Intervention adherence(Month 12)
研究者
Barbara J. Rolls
Principal Investigator
Penn State University
