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临床试验/NCT05367674
NCT05367674已完成不适用

Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities

Ohio State University2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2017年3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
192
试验地点
2
主要终点
Produce intake

研究概览

简要总结

The objective of this study is to implement and test the efficacy of the "Summer Harvest Adventure," a comprehensive garden-based behavioral, social, and environmental intervention for children (ages 8-11 years) residing in low-resource communities.

详细描述

The investigators will conduct a 2-arm randomized controlled trial designed to determine the efficacy of a multifaceted obesity prevention and lifestyle intervention in low-resource children and parent/adult caregiver (PAC) called "Summer Harvest Adventure." A total of 240 children (ages 8-11 years) will be randomized to the garden-based intervention (SHA) or an enhanced control group (MSP). Summer Harvest Adventure includes: 1) remote and group coaching using a focused motivational interviewing approach; 2) weekly fruit, vegetable, and herb harvesting to increase summer food access; and 3) group education for children and their families in a social setting. Assessments for both groups will be collected at orientation held one week prior to the intervention (week 0), and immediately following the completion of the intervention (week 10) by trained personnel that are blinded to participants' treatment arm assignment.

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 (Outcomes Assessor)

盲法说明

Clinical assessments for both groups (intervention and control) will be conducted by trained personnel that are blinded to participants' treatment arm assignment.

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children 8-11 years of age (as of June 1) from assenting and consenting families
  • English-speaking families that agree to participate; 3) residents of SNAP-eligible communities in Franklin County, Ohio.

排除标准

  • Inability to functionally participate in harvesting; accommodations can be implemented in the future for children with special needs
  • Communication difficulties (e.g. severe developmental delay)
  • Lack of transportation to weekly classes or harvesting activities
  • Non-English speakers; because coaching and classroom-based education are all conducted in English, we will of necessity restrict to English-speakers only during this phase

研究组 & 干预措施

Summer Harvest Adventure (SHA)

Experimental

Remote nutrition counseling, weekly produce harvesting, group nutrition education

干预措施: Summer Harvest Adventure (Behavioral)

My Summer Plate (MSP)

Active Comparator

Nutrition education packet

干预措施: My Summer Plate (MSP) (Behavioral)

结局指标

主要结局

Produce intake

时间窗: Baseline and 10 weeks

Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Ramon Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3)

Produce Intake

时间窗: Baseline and 10 weeks

Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Raman Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3). Dermal skin carotenoid scores range 10,000-85,000, with higher scores indicating higher skin carotenoid levels.

次要结局

  • Height(Baseline and 10 weeks)
  • Family engagement(Baseline and 10 weeks)
  • BMI percentile(Baseline and 10 weeks)
  • Weight(Baseline and 10 weeks)
  • Blood Pressure(Baseline and 10 weeks)
  • Family Engagement(Baseline and 10 weeks)
  • BMI Percentile(Baseline and 10 weeks)

研究者

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

Colleen Spees, PhD, RD, FAND, FAHA

Associate Professor

Ohio State University

研究点 (2)

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