Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools

NCT ID: NCT06335056

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2026-04-30

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.

Conditions

Treatment (ProudMe); Waitlist Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

ProudMe

Intervention Type: BEHAVIORAL

ProudMe Tech: Regular human/computer interaction (3-5 times per week) to engage in SMART goal-setting, behavior monitoring, and self-reflection as assisted by AI-enabled feedback.

ProudMe Physical Education [PE]: 12 lessons to acquire knowledge, skill, and dispositions to improve physical activity, diet, screen-based sedentary behaviors.

ProudMe Cafeteria: Purposely enabling policy and environmental changes in school cafeteria (recognize areas of strengths and weaknesses; set goals and action plans; make changes to improve scores assessed by the Smarter Lunchroom Scorecard).

ProudMe Training: 4-hour implementation training + regular check-in and support (via motivational interviewing techniques)

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.

Group Type: ACTIVE_COMPARATOR

Waitlist Control

Intervention Type: BEHAVIORAL

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

Interventions

ProudMe

ProudMe Tech: Regular human/computer interaction (3-5 times per week) to engage in SMART goal-setting, behavior monitoring, and self-reflection as assisted by AI-enabled feedback.

ProudMe Physical Education [PE]: 12 lessons to acquire knowledge, skill, and dispositions to improve physical activity, diet, screen-based sedentary behaviors.

ProudMe Cafeteria: Purposely enabling policy and environmental changes in school cafeteria (recognize areas of strengths and weaknesses; set goals and action plans; make changes to improve scores assessed by the Smarter Lunchroom Scorecard).

ProudMe Training: 4-hour implementation training + regular check-in and support (via motivational interviewing techniques)

Intervention Type: BEHAVIORAL

Waitlist Control

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: collaborator

University of Nevada, Las Vegas

OTHER

Sponsor Role: collaborator

Louisiana State University and A&M College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LSU Pedagogical Kinesiology Lab

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

1R15HD108765-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRBAM-21-0702

Identifier Type: -

Identifier Source: org_study_id