Dissemination of an Adolescent Obesity Prevention Intervention to Louisiana Schools

NCT06335056 | Enrolling By Invitation DMC

• 2 other identifiers: IRBAM-21-07021R15HD108765-01A1
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment (ProudMe); Waitlist Control

Outcome Measures

Primary Outcomes (3)

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

  Self-reported screen time

  12 weeks

• Screen time

  a screen time questionnaire

  12 weeks

• Food environment

  Parent-reported Food Frequency Questionnaire

  12 weeks

Secondary Outcomes (2)

• Body mass index z score

  12 weeks

• Waist circumference

  12 weeks

Other Outcomes (5)

• Activity self-efficacy

  12 weeks

• Self-monitoring

  3-5 times per week over 12 weeks

• Social support

  12 weeks

Study Arms (2)

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).

Behavioral: ProudMe

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.

Behavioral: Waitlist Control

Interventions

ProudMe 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)

ProudMe

Waitlist Control 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.

Waitlist Control

Eligibility Criteria

• Age: 10 Years - 15 Years
• Gender Eligibility Details: All genders are eligible to participate in the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University and A&M College: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Pennington Biomedical Research Center: collaborator
• Texas A&M University: collaborator
• University of Nevada, Las Vegas: collaborator

Study Sites (1)

LSU Pedagogical Kinesiology Lab

Baton Rouge, Louisiana, 70803, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this 12-week long intervention project, 480 adolescent participants are randomized, at the school level, to 2 arms - ProudMe or waitlist control conditions.

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 28, 2024
• Study Start: February 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)