跳至主要内容
临床试验/NCT06335056
NCT06335056Enrolling By Invitation不适用

Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools

Louisiana State University and A&M College2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2024年2月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
480
试验地点
2
主要终点
Screen time

研究概览

简要总结

This project aims to test the effectiveness and implementation of an adolescent obesity prevention intervention called ProudMe. The study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools) and expect to observe improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to the control. The investigators also collect mixed-methods data from 24 school implementers at the 6 ProudMe schools and expect to observe appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.

详细描述

The Louisiana-based, 12-week, multi-level, multi-component, ecological intervention is called Preventing Obesity Using Digital-assisted Movement and Eating (ProudMe). Guided by robust theories and prior work, this project involves multiple trained student researchers to address two specific aims.

Aim 1: to test the effectiveness of the ProudMe intervention in Louisiana middle schools. Informed by power analysis (80% statistical power), the study recruits 480 adolescents from 12 middle schools (cluster-randomized to 6 ProudMe schools vs 6 wait-list control schools). Quantitative data on obesity-prevention behaviors (i.e., physical activity, screen-based sedentary behavior, diet behaviors) and weight status (i.e., body mass index z score, waist circumference) are collected from all adolescent participants using validated instruments and procedures. The investigators hypothesize the multi-level modeling analyses to show improvements of obesity-prevention behaviors and weight status in the ProudMe group compared to a waist-list control, after controlling for sociodemographic factors at multiple ecological levels.

Aim 2: to test the implementation outcomes of the ProudMe intervention in Louisiana middle schools. The investigators collect mixed-methods data from 24 school implementers (i.e., teachers, administrators, and staff), 96 adolescents, and 96 parents at the 6 ProudMe schools, to capture adaptation and implementation indicators. The investigators evaluate the adaptations made across three phases (early, mid, late) of the implementation (i.e., what, at what level, when, how, why, by whom, and impact to intervention). In addition, the investigators assess reach, fidelity, penetration, sustainability, and cost of the implementation across early, mid, and late phases of the implementation. The investigators expect the ProudMe schools to show appropriate levels of adaptation, fidelity, reach, penetration, and sustainability, with manageable time and financial cost.

Building on previously funded work (e.g., R21HD090513, PI: Dr. Chen), this project is led by a strong, collaborative, transdisciplinary team with experts from kinesiology, developmental psychology, nutrition, childhood obesity, computer science, statistics, and implementation science. The project significantly strengthens the research environment of the Louisiana State University (LSU) - a primarily undergraduate student serving institution under-funded by the NIH. The project creates unique opportunities that are otherwise unavailable for LSU students who aspire to seek advanced education or careers in biomedical and health fields.

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
None

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Students enrolled in 6th, 7th, or 8th grades in participating schools.
  • Students with parental consent and child assent.

排除标准

  • Students enrolled in grades other than 6th, 7th, or 8th grades
  • Students in non-participating schools.
  • Students without parental consent and child assent.
  • Students without adequate readiness for physical activity.

研究组 & 干预措施

ProudMe

Experimental

The ProudMe condition involves three key components: (a) artificial intelligence (AI)-assisted behavior management system (i.e., ProudMe Tech), (b) ProudMe physical/health education (PE) and lunchroom reform (ProudMe Cafeteria), (c) customized implementation training (ProudMe Training).

干预措施: ProudMe (Behavioral)

Waitlist Control

Active Comparator

The waitlist control involves (a) regular physical/health education and lunchroom, (b) professional development training on the importance of quality physical/health education, health eating and foot environment. It does not involve AI-assisted behavior management system.

干预措施: Waitlist Control (Behavioral)

结局指标

主要结局

Screen time

时间窗: 12 weeks

a screen time questionnaire

Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers

时间窗: 12 weeks

Self-reported screen time

Food environment

时间窗: 12 weeks

Parent-reported Food Frequency Questionnaire

次要结局

  • Body mass index z score(12 weeks)
  • Waist circumference(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Dissemination of an Adolescent Obesity Prevention... | 临床试验