Clinical trial NCT06335056: Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
Official title: Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Treatment (ProudMe)
Waitlist Control
Lead sponsor: Louisiana State University and A&M College
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Pennington Biomedical Research Center
name: Texas A&M University
name: University of Nevada, Las Vegas
First posted: 2024-03-28
Enrollment: 480
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Physical activity: NHANES physical activity recall question, Leisure-Time Exercise Questionnaire, ActiGraph accelerometers
timeFrame: 12 weeks
measure: Screen time
timeFrame: 12 weeks
measure: Food environment
timeFrame: 12 weeks
Secondary outcomes:
measure: Body mass index z score
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
Other outcomes:
measure: Activity self-efficacy
timeFrame: 12 weeks
measure: Self-monitoring
timeFrame: 3-5 times per week over 12 weeks
measure: Social support
timeFrame: 12 weeks
measure: School Wellness Policy
timeFrame: 12 weeks
measure: Cafeteria Nutrition
timeFrame: 12 weeks
Locations:
city: Baton Rouge
country: United States
facility: LSU Pedagogical Kinesiology Lab
state: Louisiana
Study officials:
References: