Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
- Conditions
- Waitlist ControlTreatment (ProudMe)
- Interventions
- Behavioral: ProudMeBehavioral: Waitlist Control
- Registration Number
- NCT06335056
- Lead Sponsor
- Louisiana State University and A&M College
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 480
- Students enrolled in 6th, 7th, or 8th grades in participating schools.
- Students with parental consent and child assent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ProudMe ProudMe 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). Waitlist Control Waitlist Control 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.
- Primary Outcome Measures
Name Time Method Screen time 12 weeks a screen time questionnaire
Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers 12 weeks Self-reported screen time
Food environment 12 weeks Parent-reported Food Frequency Questionnaire
- Secondary Outcome Measures
Name Time Method Body mass index z score 12 weeks Body mass index (BMI) z scores and BMI scores are converted by weight and height. Body weight is measured to the nearest 0.1kg with a calibrated Seca Model 770 scale. Raw BMI score is calculated from height and body weight as follows: BMI (kg/m2) = Body weight (kg) / Height (m)2. BMI-z score is calculated to examine how many standard deviations adolescents' BMI is above or below the average BMI value for their age group and gender.
Waist circumference 12 weeks Waist circumference at the umbilicus is assessed to the nearest 0.5cm using a constant tension tape.
Trial Locations
- Locations (1)
LSU Pedagogical Kinesiology Lab
🇺🇸Baton Rouge, Louisiana, United States