Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools

NCT06335056 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2024-03-28

No results posted yet for this study

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.

Conditions

  • Treatment (ProudMe)
  • Waitlist Control

Interventions

BEHAVIORAL

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)

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.

Sponsors & Collaborators

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

    collaborator NIH
  • Pennington Biomedical Research Center

    collaborator OTHER
  • Texas A&M University

    collaborator OTHER
  • University of Nevada, Las Vegas

    collaborator OTHER
  • Louisiana State University and A&M College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06335056 on ClinicalTrials.gov