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临床试验/NCT02928874
NCT02928874已完成不适用

Eating Phenotypes for Childhood Obesity in the Context of Familial Obesity Risk

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2014年9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
212
试验地点
1
主要终点
Waist circumference (cm)

研究概览

简要总结

Using an integrated approach, this study examines multiple eating traits concurrently under states of hunger and satiety. It examines the impact of short-term appetite and intake regulation on longer-term energy intake control and weight development in a cohort of ethnically diverse normal-weight and obese boys and girls with different familial predispositions to obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
7 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •7-9 years of age
  • •Normal-weight or overweight/obese who are at low risk or high risk for obesity based on maternal BMI
  • •Like most foods served during the study
  • •Be regular breakfast eaters

排除标准

  • •Have serious medical conditions known to affect food intake or body weight
  • •Have any developmental, medical, or psychiatric conditions that might impact study compliance
  • •Have a learning disability or poor reading ability/comprehension
  • •Have visual or auditory impairment
  • •Are taking medications associated with developmental, medical, or psychiatric disorders or medications known to affect appetite, food intake or body weight
  • •Are underweight
  • •Have food allergies related to the foods served in the study or are lactose intolerant
  • •Do not regularly eat breakfast
  • •Do not like or cannot eat foods served during experimental meal or are unable to finish compulsory preload
  • •Mothers who are pregnant

研究组 & 干预措施

Caloric compensation

Experimental

Twenty-five minutes before breakfast, participants will be asked to consume in full one of two oatmeal preloads that will vary in ED. The order of preload conditions will be randomized across groups of children participating in the visits.

干预措施: % COMPX (low ED vs. high ED preload) (Behavioral)

Eating in the absence of hunger (EAH)

Experimental

During both study visits, children's EAH will be assessed after lunch and again after dinner. The order of presenting the low and high ED snacks will be counterbalanced across meals.

干预措施: EAH (low ED vs. high ED snacks) (Behavioral)

结局指标

主要结局

Waist circumference (cm)

时间窗: Change from baseline waist circumference at 1-year follow-up

Appetite ratings assessed via Visual Analog Scales

时间窗: Baseline

Appetite ratings include self-reported perceived hunger, desire to eat, prospective consumption, and fullness.

Percent caloric compensation index (%COMPX)

时间窗: Baseline

Total energy intake per day (number of calories consumed over 24-hours)

时间窗: Baseline

Number of calories consumed over 24-hours assessed via measured food intake in the laboratory and via parent-reported food intake at home.

BMI z-score

时间窗: Change from baseline BMI z-score at 1-year follow-up

Percentage body fat

时间窗: Change from baseline percentage body fat at 1-year follow-up

次要结局

  • Eating in the absence of hunger (kcal)(Baseline (number of calories consumed from snacks))
  • Home food environment(Baseline home food environment assessed using the Home Food Inventory)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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