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临床试验/NCT05563506
NCT05563506已完成不适用

The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices

New Mexico State University4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
4
主要终点
After-School Student Questionnaire (ASSQ)

研究概览

简要总结

The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years.

详细描述

The purpose of this study is to implement and evaluate the Healthy Kids+ initiative -- a community-engaged research project - through an existing after-school program in Las Cruces, NM. The Healthy Kids+ initiative will encourage daily lifestyle behaviors (5 or more servings of fruits and vegetables, 2 hours or less of recreational screen time, 1 hour of physical activity, 0 sugary drinks, 10 hours of sleep) that impact childhood obesity. This research project will integrate lessons and activities designed to help kids incorporate changes into their lives to enhance their health and wellness. Overall, it is expected that children participating in the Healthy Kids+ initiative, three times per week, will demonstrate significant changes in improving lifestyle behaviors and maintaining both cognitive and affective changes.Healthy Kids+ will be integrated into the 21st Century afterschool program to provide children at the school sites with relevant PA and health related programming throughout the year. The proposed study will include a repeated-measures research design. A power analysis revealed that for a moderate effect size (f = .25, Cohen, 1988), with five percent type I error and 80% power, three follow up time points, and within subject's correlation of 0.5, we will need to recruit at a minimum 100 total participants. However, our potential participant pool is much larger, and thus we plan on over recruiting (N = 200) to mitigate lost data from attrition rates. The Healthy Kids+ program will be implemented three times a week for 30 weeks. A midyear assessment will be conducted 15-weeks into the program. Participants will then take part in a post assessment at the completion of the 30-week program. The primary quantitative outcome measures include levels of lifestyle behaviors (PA, healthy eating habits, screen time, sleep). The outcome measures will also include self-efficacy, self-esteem, and the level of readiness to change relevant to aforementioned lifestyle behaviors.

Based on Healthy Kids+, we revised and partnered with Fred Hutchinson Cancer Center to expand this trial. For this follow up project, we will recruit 30 children total at NMSU. For this follow up project, we will use accelerometer to objectively measure physical activity and sleep, as well as validated surveys measures for dietary intake and related health outcomes.

研究设计

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

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 ages 8-11 years enrolled in the after-school program at the selected sites.

排除标准

  • Children not enrolled in the after-school program at the selected sites.

结局指标

主要结局

After-School Student Questionnaire (ASSQ)

时间窗: 2 weeks

A self-administered questionnaire that measures the behavioral and psychosocial variables targeted by the intervention. ASSQ survey items were modified from the Health Behavior Questionnaire and the School-Based Nutrition Monitoring Student Questionnaire, both of which have been found to have acceptable internal consistency (greater than 0.6). Measured constructs in the ASSQ included: food preferences, dietary knowledge, self-efficacy, intentions to choose healthful food options, and participation in sedentary and sports activities.

次要结局

  • Physical Activity Questionnaire for Children (PAQ-C)(1 week)
  • Children's Sleep Habits Questionnaire (CSHQ)(1 week)

研究者

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

Dejan Magoc

Assistant Professor

New Mexico State University

研究点 (4)

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