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临床试验/NCT04178824
NCT04178824已完成不适用

Multi-level Supermarket Discounts of Fruits and Vegetables' Impact on Intake and Health

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
312
试验地点
1
主要终点
Fruit Intake as Assessed by 24-h Dietary Recalls

研究概览

简要总结

The study team's objective is to test the effect of supermarket discount levels on fruit and vegetable (F&V) and non-caloric beverage purchasing and consumption, as well as health outcomes. The study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (F&V) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. The 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. There will be no discounts in effect during the baseline and follow-up periods.

详细描述

The objective is to test the effect of supermarket discount levels on fruit and vegetable (F&V) and non-caloric beverage purchasing and consumption, as well as health outcomes. The study team will implement this economic intervention in a local supermarket chain to assess the effects of a 32-week intervention of fruit and vegetable (F&V) and non-caloric beverage discounts of 30%, 15%, and 0% (control group) on purchasing, dietary intake, and health outcomes, including body weight and composition, blood pressure, and biochemical markers of cardiovascular disease risk. The prediction is that the impact will increase with the level of discount. The 32-week intervention will be preceded by an 8-week baseline and will have a follow-up period of 16 weeks. There will be no discounts in effect during the baseline and follow-up periods. The prediction is that some of the interventional effects will carry over to the follow-up period.

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

入选标准

  • BMI: 24.5 - 50
  • Weight Stable (±5% body weight in last 3 mo)
  • Accessible by telephone
  • Living in NYC and not planning move
  • Primary household food shopper
  • ≥50% of food shopping at Foodtown/Brooklyn Harvest and agrees to 100% shopping at store during study
  • Consumption of >50% of food shopping
  • Eat out or take out ≤5 times weekly

排除标准

  • Pregnant or contemplating pregnancy
  • Enrolled in related studies
  • Active weight loss program
  • Presence of serious medical (e.g. cancer, diabetes) or psychiatric disease (e.g. bipolar)
  • Changes in medications or smoking in past 3 mo
  • Excessive alcohol use (≥4 drinks/day) or illicit drug use
  • Planning a vacation ≥ 4 consecutive weeks or 6 total weeks during study
  • Receiving SNAP benefits

结局指标

主要结局

Fruit Intake as Assessed by 24-h Dietary Recalls

时间窗: Week 8, 24, 40, 56

Individual consumption behaviors: Fruit intake as assessed by 24-h dietary recalls

Vegetable Intake as Assessed by 24-h Dietary Recalls

时间窗: Week 8, 24, 40, 56

Individual consumption behaviors: Vegetable intake as assessed by 24-h dietary recalls

Bottled Water Intake as Assessed by 24-h Dietary Recalls

时间窗: Week 8, 24, 40, 56

Individual consumption behaviors: bottled water intake as assessed by 24-h dietary recalls

Seltzer Water Intake as Assessed by 24-h Dietary Recalls

时间窗: Week 8, 24, 40, 56

Individual consumption behaviors: seltzer water intake as assessed by 24-h dietary recalls

Diet Soda Intake as Assessed by 24-h Dietary Recalls

时间窗: Week 8, 24, 40, 56

Individual consumption behaviors: diet soda intake as assessed by 24-h dietary recalls

Total Non-caloric Beverage Intake as Assessed by 24-h Dietary Recalls

时间窗: Week 8, 24, 40, 56

Individual consumption behaviors: Total non-caloric beverage intake as assessed by 24-h dietary recalls

次要结局

  • Body Weight(Week 0, 8, 24, 40, 56)
  • Body Mass Index (BMI)(Week 0, 8, 24, 40, 56)
  • Percent Body Fat(Week 0, 8, 24, 40, 56)
  • Waist Circumference(Week 0, 8, 24, 40, 56)
  • Fasting Glucose(Week 0, 8, 24, 40, 56)
  • Cholesterol Level(Week 0, 8, 24, 40, 56)
  • Blood Pressure(Week 0, 8, 24, 40, 56)
  • Gross Weekly Purchasing of Fruits and Vegetables(Week 8-56)

研究者

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

Allan Geliebter

Senior Scientist

Icahn School of Medicine at Mount Sinai

研究点 (1)

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