跳至主要内容
临床试验/NCT06303544
NCT06303544招募中不适用

More Outside Your Door (MOYD): a Multilevel Intervention Promoting Traditional Diet and Physical Activity to Decrease Risk of Obesity in Alaska Native (AN) Preschoolers

Alaska Native Tribal Health Consortium2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2024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
招募中
入组人数
450
试验地点
2
主要终点
Physical activity

研究概览

简要总结

The preschool age is a crucial period of growth and an optimal time to begin to establish healthy eating and physical activity habits leading to better food and activity choices into adulthood, thereby minimizing risk for obesity-related diseases and decreasing the cardiometabolic disparities in this Indigenous population. More Outside Your Door is a multi-level, randomized, stepped-wedge intervention trial designed to reduce the disparity of childhood obesity in Yup'ik Alaska Native children by increasing the proportion of nutrient-dense traditional and traditional-like foods offered and increasing physical activity, particularly outdoor activities related to traditional Yup'ik subsistence and lifestyle practices. This 5-year intervention trial targeting 3-5 year olds is conducted in partnership with Rural Action Community Action Program Head Start programs in 12 rural Alaskan communities, where each site is assigned annually to a wedge group to receive either a community-altered culturally-tailored 8-month traditional foods and activities curriculum intervention or the standard regional Head Start program intervention.

详细描述

The Rural Alaska Community Action Program (RurAL CAP), which administers Head Start schools in rural Alaska, reports that 68% of Alaska Native children ages 3 to 5 years are overweight and 43% are obese. Diet, physical activity, and sleep hygiene are primary risk factors for childhood obesity, a risk factor for cardiometabolic diseases later in life. Notably, subclinical cardiovascular pathology can be detected as early as 3 years of age. Once living off the land and sea, Alaska Native (AN) people have suffered decades of colonization and in-migration, which have interfered with traditional food consumption, signaling a striking change in local food systems. Diet and physical activity are prime targets for early intervention, as taste preferences and exercise habits established in childhood forge lifelong adherence. Thus, investigators have designed More Outside Your Door, a multilevel intervention, which at the individual level builds on prior efforts to promote traditional diet and activities to decrease risk for obesity in Alaska Native preschoolers. At the family level, MOYD provides feedback to parents about their child's health screenings; at the school level, it features traditional foods, outdoor traditional physical activities, and a culturally centered curriculum. At the community level, it offers resources to improve the built environment for safe outdoor play that invites all community members to participate. In partnership, the Alaska Native Tribal Health Consortium, RurAL CAP, and collaborators will refine and test the effectiveness of MOYD at 12 Head Start preschools in the Yukon-Kuskokwim region: (1) investigators will use qualitative methods with Head Start staff, parents, and community Elders to optimally tailor MOYD for southwest Alaska communities; (2) investigators will conduct a stepped-wedge group-randomized trial to test its effect on children's diet, physical activity (PA), body mass index (BMI), and other risk factors for obesity-related chronic disease over three years. Primary outcomes are diet (classroom meals, actigraphy-based physical activity, and body mass index. Secondary outcomes include individual child level measures of hemoglobin levels and educational and developmental progress; parent report of diet, activity, and sleep at home; and measures of traditional foods/sugar-sweetened/processed foods by carbon and nitrogen stable isotope ratios using fingernail clippings. Investigators will also measure outcomes at the school level (classroom meals, outdoor time) and community level (objective data on use of play space). (3) Investigators will conduct a process evaluation using the RE-AIM framework. The Specific Aims are to (1) conduct preschool staff and parent/elder workgroups to refine the MOYD intervention for optimal effectiveness for obesity prevention among AN preschool children; (2) test the effectiveness of MOYD on a) diet, PA, outdoor time, and BMI; and b) improving other clinical and behavioral risk factors for obesity-related chronic disease in preschool children; and (3) Implement the RE-AIM framework to evaluate dissemination and implementation of the MOYD intervention in Head Start programs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
None

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

  • parent who identifies as Alaska Native (AN)
  • parental consent
  • enrolled in preschool in one of the12 participating Head Start programs
  • present at school for health screenings

排除标准

  • lack of parental consent
  • does not have a parent who is AN

研究组 & 干预措施

Wedge 1

Experimental

Four villages of 12 will be randomized into Wedge 1. Four of the remaining 8 villages will be randomized to Wedge 2. The remaining 4 villages will be Wedge 3.

干预措施: Wedge 1 (Behavioral)

Wedge 2

No Intervention

While Wedge 1 is undergoing intervention, Wedges 2 & 3 will act as controls.

Wedge 3

No Intervention

While Wedge 1 is undergoing intervention, Wedges 2 & 3 will act as controls.

结局指标

主要结局

Physical activity

时间窗: 3 years

Measured via accelerometers (minutes)

Outdoor time

时间窗: 3 years

Time (minutes) spent outdoors by children

BMI

时间窗: 3 years

Body mass index (kg/m2)

Fingernail nitrogen & carbon stable isotope ratios

时间窗: 3 years

Measurements of traditional food intake and added sugar intake

Sleep quality

时间窗: 3 years

Hours of sleep measured by survey

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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