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临床试验/NCT03986632
NCT03986632Unknown不适用

Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities

University of Alaska Fairbanks0 个研究点目标入组 500 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
Change in child screen time

研究概览

简要总结

The long-term goal of this community based participatory research project is to prevent obesity in 3-5 year old Alaska Native children in remote communities.

Investigators will design and evaluate a culturally responsive, home-focused intervention, Tundra Gifts, that links early childhood education programming (i.e. Head Start) and federal food assistance programs (i.e. WIC and SNAP) with primary caregivers to support healthy eating and an active lifestyle using a cluster-randomized design. The intervention integrates behavior change theory with Indigenous traditional knowledge. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site. Investigators will also evaluate key process indicators of Tundra Gifts to understand the impact on outcomes of variations in persons and settings and to enhance the generalizability of findings.

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 (Participant)

入排标准

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

入选标准

  • 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities

排除标准

  • 未提供

结局指标

主要结局

Change in child screen time

时间窗: twice annually for 3 years

Screen time questionnaire

Change in child physical activity

时间窗: twice annually for 3 years

Physical activity questionnaire

Change in age- and sex-specific BMI percentiles and z-scores

时间窗: twice annually for 3 years

Change in child intake of vegetables and fruit

时间窗: twice annually for 3 years

24-hour recall in combination with a 2-day food record

Change in child intake of sugar sweetened beverages

时间窗: twice annually for 3 years

Hair biomarker of sugar using N and C stable isotope ratios

次要结局

  • Change in adult BMI(twice annually for 3 years)
  • Change in adult intake of vegetables and fruit(twice annually for 3 years)
  • Change in adult attitudes and beliefs around healthy eating and active lifestyle(twice annually for 3 years)

研究者

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

Andrea Bersamin

Associate Professor

University of Alaska Fairbanks

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