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临床试验/NCT00113672
NCT00113672已完成不适用

Multiple Behavior Change in Diet and Activity

Northwestern University2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
204
试验地点
2
主要终点
Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6)

研究概览

简要总结

The purpose of this study is to examine the impact of diet and exercise on an individual's health.

详细描述

BACKGROUND:

The majority of adult Americans consume a high saturated fat diet, have a low fruit and vegetable (F/V) intake, and lead a sedentary lifestyle. This unhealthy lifestyle heightens their risk for cardiovascular disease and cancer. Improving diet and activity can reduce risk, but the best prescription to promote a healthier diet and a more active lifestyle remains unknown. This study will randomly assign participants to 4 groups, which will include all combinations of increasing healthy eating and activity and decreasing unhealthy eating and activity. The Familiarity Hypothesis predicts that the most familiar dieting prescription (decrease fat, increase physical activity) will maximize healthy behavior change. The Optimal Substitution Hypothesis, based on Behavioral Economic Theory, predicts that increasing F/V intake while decreasing sedentary behavior will surpass alternative methods by maximizing behavioral substitution of healthful eating and activity for unhealthful eating and activity. The Low Inhibitory Demand Hypothesis, based on Self-Control Theory, predicts that increasing F/Vs while increasing physical activity will be most successful because this prescription places the fewest demands on self-control resources.

DESIGN NARRATIVE:

The study will randomize 200 sedentary community-dwelling adults with a suboptimal diet to 1 of 4 groups including: 1) increase healthy eating and activity; 2) decrease unhealthy eating and activity; 3) increase healthy eating and decrease unhealthy activity; and 4) decrease unhealthy eating and increase healthy physical activity. Subjects will self-monitor diet, physical activity, and mood via PDAs during a 2-week baseline period, a 3-week prescription period (when payment is contingent upon changing eating and activity simultaneously to targeted standards), and a 4-month maintenance period. Targeted and collateral diet and activity changes will be measured by self report, accelerometer, and grocery receipts. Bogus pipeline urinary testing will encourage adherence. Laboratory testing will measure behavioral choices, craving, and attentional allocation to restricted foods and activities in a permissive context in order to shed light on behavioral and psychological processes that mediate healthy lifestyle change. Findings will help to fill an important gap in clinical knowledge about how to optimize healthy simultaneous change in diet and activity among adults.

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 (Investigator)

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Sedentary community dwelling adults with a suboptimal diet
  • Motivated to make changes in diet and activity level

排除标准

  • Few exclusion criteria will be implemented in order to enhance generalizability
  • For safety, participants with unstable medical conditions (uncontrolled hypertension, diabetes, recent myocardial infarction) will be excluded. Those with stable medical conditions will require physician approval to participate but will not be excluded because the prescribed changes in diet and activity match healthy, attainable guidelines for all Americans.
  • Cannot read the study questionnaires
  • Committed to following an incompatible dietary regimen
  • Pregnant, trying to get pregnant, or breastfeeding
  • People with anorexia, bulimia, or report active suicidal ideation will not be enrolled because they might practice overly severe dietary restrictions
  • Binge eating disorder
  • Current substance abuse or dependence, other than nicotine dependence will be excluded because of concern about their ability to maintain accurate records of intake and activity. Smokers will be accepted and during recreational laboratory sessions will be able to smoke cigarettes in an adjoining room that is used as a smoking laboratory.

结局指标

主要结局

Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6)

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bonnie Spring

Professor

Northwestern University

研究点 (2)

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