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临床试验/NCT03394326
NCT03394326已完成不适用

Implementing a Dietary Energy Density Intervention in Preschool Children

University of Delaware1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Energy Intake

研究概览

简要总结

This study investigates the effect of a low energy-density dietary prescription as compared to MyPlate recommendations in preschool children at risk for obesity.

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
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •the parent is ≥18 years-old with a BMI ≥30 kg/m2 (indicating the child to be at risk for obesity);
  • •the child is 2-5 years-old with a BMI-for-age and sex <95th percentile;
  • •the parent and child live together ≥50% of the time;
  • •the parent and child are able to read, speak and understand English;
  • •the family has transportation to the University of Delaware; and
  • •the family is committed to the 6-month program.

排除标准

  • •the child is participating in a weight management program or seeing a Registered Dietitian for weight loss;
  • •the child is taking weight loss medication or medication that impacts appetite; or
  • •the child has a medical condition that impacts growth or has a medical condition that requires a specific eating plan.

研究组 & 干预措施

LOW-ED

Experimental

In the LOW-ED condition each participant will consume at least 10 low-ED foods/day (ED ≤1.0 kcal/g) and no more than 2 high ED foods/day (ED ≥3.0 kcal/g). Foods with an ED >1.0 kcal/g and <3.0 kcal/g will be unlimited; however, lowering the overall ED of the diet will be encouraged.

干预措施: family-based obesity prevention lifestyle intervention (Behavioral)

STANDARD

Active Comparator

In the STANDARD condition participants will consume the recommendations for calories, fruits, vegetables and whole grains based on age and sex corresponding with MyPlate. The daily caloric recommendations from MyPlate are for weight maintenance.

干预措施: family-based obesity prevention lifestyle intervention (Behavioral)

结局指标

主要结局

Energy Intake

时间窗: 6 months

Dietary intake will be analyzed using NDSR and energy intake will be calculated.

Dietary Quality

时间窗: 6 months

Dietary intake will be analyzed using NDSR and used to calculate a Healthy Eating Index score.

Dietary Energy Density

时间窗: 6 months

Dietary intake will be analyzed using NDSR and energy density (kcal/g) will be calculated.

次要结局

  • zBMI(6 months)

研究者

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

Shannon Robson

Principal Investigator

University of Delaware

研究点 (1)

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