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临床试验/NCT03641716
NCT03641716已完成不适用

Family Empowerment for Enhanced Development

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月26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
20
试验地点
1
主要终点
Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months

研究概览

简要总结

This study evaluates the feasibility and preliminary effects of offering the Mealtime PREP intervention to low-income families with young children. All enrolled families will receive the Mealtime PREP intervention in the home to evaluate the effects on child nutrition.

详细描述

Children have not been spared from the obesity epidemic. There is a great need for innovative interventions to help families build healthy habits early in life for obesity prevention. Low-income preschoolers have a disproportionately high rate of childhood obesity, and their families face complex barriers to healthy behavior change. This proposed pilot study will examine the feasibility of delivering the Promoting Routines of Exploration and Play during Mealtime (Mealtime PREP) intervention in a sample of low-income families with young children (ages 2-5). Our parent-mediated intervention is designed to promote healthy dietary variety using routine family meals, positive reinforcement, social modeling, and food exploration and play. By harnessing the behavior change capacity of behavioral activation to alter daily mealtimes incrementally, parents are empowered to overcome barriers to healthy habit formation. Each family will participate in a six-week intervention that is delivered by occupational therapy clinicians in the home environment. Each session will last approximately one hour and include individualized parent-training and a parent-led mealtime with direct feedback from the clinician. We planned to screen up to 100 potential parent and child participants, with a plan to deliver intervention to 20 child participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •within age range 2-5 years
  • •reside in a low-income household (as specified by income within the range to qualify for Special Supplemental Nutrition Program for Women, Infants, and Children.
  • •>18 years old
  • •ability to read and speak in English
  • •willing to participate in 6 home-based intervention sessions

排除标准

  • 未提供

研究组 & 干预措施

Mealtime PREP Intervention

Experimental

Parents of young children will receive 6 weekly sessions, each lasting approximately one-hour, in the home environment. An occupational therapy clinician will deliver the Mealtime PREP intervention to the family.

干预措施: Mealtime PREP Intervention (Behavioral)

结局指标

主要结局

Change From Baseline 3-Day Food Diary (Dietary Variety) at 3 Months

时间窗: baseline and 3 months

The 3-Day Food Diary is the preferred method of dietary assessment (intake and variety of food consumed) because of a balance between validity and burden. Includes all food consumed and approximate servings for 3 days. Servings of foods consumed from each food group will be tallied and compared to national daily recommendations. We calculated the number of unique foods consumed at baseline and the 3-month follow-up.

次要结局

  • Change From Baseline Nutrition Screening Tool for Every Preschooler (Nutritional Risk) at 3 Months(baseline and 3 months)
  • Change From Baseline Parenting-Stress Inventory, Short-Form (PSI-SF) to 3 Months(Baseline, 3 months)

研究者

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

Angela Caldwell

Assistant Professor

University of Pittsburgh

研究点 (1)

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