ProudMe Program for Childhood Obesity

(ProudMe Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Louisiana State University and A&M College

Disqualifiers: Non-participating schools, No parental consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called ProudMe, which aims to prevent obesity in adolescents by improving their health habits and weight. The program uses technology to support behavior management and includes changes in physical education and school cafeterias. Students in grades 6 to 8 from selected schools can join, provided they have parental permission and are ready to participate in physical activities. The trial compares students using ProudMe with those following regular school activities to determine which is more effective. As an unphased trial, this study offers students a unique opportunity to participate in innovative research that could positively impact their health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the ProudMe program is safe for adolescents?

Research shows that specific safety information for the ProudMe Program, which aims to prevent obesity in teenagers, is not available. However, similar community programs have generally proven safe. While direct safety evidence for ProudMe is lacking, other similar programs have not shown major safety issues. ProudMe focuses on improving diet and exercise habits through school activities, which are typically safe and involve minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ProudMe program for childhood obesity is unique because it includes an AI-assisted behavior management system, which sets it apart from traditional methods like diet and exercise plans. This innovative approach, called ProudMe Tech, helps personalize and optimize behavior changes for each child. Additionally, ProudMe incorporates physical and health education reforms alongside tailored implementation training, aiming to create an all-encompassing environment for sustainable lifestyle changes. Researchers are excited because this comprehensive and tech-driven strategy could lead to more effective and lasting results in managing childhood obesity compared to conventional treatments.

What evidence suggests that the ProudMe program is effective for childhood obesity?

Research has shown that the ProudMe program, which participants in this trial may receive, can help reduce childhood obesity. In a previous study, children who participated in a 12-month version of ProudMe experienced a noticeable decrease in their Body Mass Index (BMI), from 25.9 to 24.5 kg/m². This suggests that components of the program, such as the AI-assisted behavior management system and changes in school settings, can significantly impact outcomes. Additionally, the ProudMe Cafeteria proved very successful in past trials, demonstrating its potential as a key element in preventing obesity in schools. While some components, like the physical education aspect, achieved moderate success, the overall program appears promising. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adolescents in middle school who are looking to prevent obesity. It's being conducted across 12 schools, with half receiving the intervention and the other half on a waitlist control group. Participants should be willing to engage in obesity-prevention behaviors and have their weight status monitored.

Inclusion Criteria

I am a middle school student in 6th, 7th, or 8th grade.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the ProudMe intervention in Louisiana middle schools, including AI-assisted behavior management, physical/health education, and lunchroom reform

12 weeks

Regular school visits

Data Collection and Evaluation

Collection of quantitative data on obesity-prevention behaviors and weight status, and evaluation of implementation outcomes such as adaptation, fidelity, reach, penetration, and sustainability

12 weeks

Follow-up

Participants are monitored for sustainability of obesity-prevention behaviors and weight status improvements

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ProudMe

Trial Overview

The study is testing 'ProudMe', an adolescent obesity prevention program, against a waitlist control where no immediate intervention is provided. The effectiveness of ProudMe will be measured by improvements in behavior and weight status among students from schools that implement it.

How Is the Trial Designed?

Group I: ProudMe Experimental Treatment 1 Intervention

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 II: Waitlist Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Louisiana State University and A&M College

Lead Sponsor

Trials

12

Recruited

1,100+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Pennington Biomedical Research Center

Collaborator

Trials

314

Recruited

183,000+

University of Nevada, Las Vegas

Collaborator

Trials

81

Recruited

14,700+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+

Published Research Related to This Trial

Project Healthy Schools (PHS) has demonstrated significant improvements in health metrics and lifestyle behaviors among middle school students in Michigan, indicating its effectiveness in addressing childhood obesity.

The program's success is linked to collaborative efforts among stakeholders and changes in the school environment, suggesting that such comprehensive approaches can be replicated to combat childhood obesity in other settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Top 10 Lessons Learned from Project Healthy Schools. Rogers, R., Krallman, R., Jackson, EA., et al.[2019]

A 2-week residential summer camp for 21 obese children led to significant improvements in various health metrics, including a reduction in body weight by an average of 3.7 kg and a decrease in BMI by 1.60 kg/m².

Participants also experienced enhanced self-esteem and better cardiovascular health, with notable reductions in blood pressure and heart rate, indicating the camp's potential effectiveness in addressing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative summer camp program improves weight and self-esteem in obese children. Wong, WW., Abrams, SH., Mikhail, C., et al.[2022]

A 12-month structured multidisciplinary weight management program for 77 obese children led to a significant reduction in BMI from 25.9 to 24.5 kg/m² and BMI percentiles from 97.3% to 92.6%, indicating its efficacy in managing childhood obesity.

Children with higher initial BMI percentiles and those with overweight parents showed less favorable outcomes from the intervention, suggesting that these factors may influence the success of weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental obesity and higher pre-intervention BMI reduce the likelihood of a multidisciplinary childhood obesity program to succeed--a clinical observation. Eliakim, A., Friedland, O., Kowen, G., et al.[2022]

A multidisciplinary pediatric weight management program showed a small but significant decrease in BMI z-score among high-risk children after 9 months, indicating some improvement in weight status.

The program also led to significant improvements in cardiovascular risk factors, such as total cholesterol and triglyceride levels, highlighting its effectiveness in addressing obesity-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pediatric weight management program for high-risk populations: a preliminary analysis. Skelton, JA., DeMattia, LG., Flores, G.[2009]

Participation in the Fit2Play™ afterschool program led to significant reductions in body mass index (BMI) percentiles for overweight and obese children, indicating effective weight management over one school year with 1546 participants.

The program also improved cardiovascular health, as evidenced by significant decreases in systolic and diastolic blood pressure, along with enhanced fitness levels and nutrition knowledge among all participants, highlighting its potential as a valuable intervention for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a park-based afterschool program replicated over five years on modifiable cardiovascular disease risk factors. Messiah, SE., Vidot, D., Hansen, E., et al.[2022]

In a study of 394 obese youth aged 5 to 19, participation in a family-centered outpatient weight management program led to significant reductions in weight, BMI, and BMI z score over an average of 5.6 months, without hindering growth.

Improvements in metabolic health were also observed, with many participants achieving normal blood pressure, cholesterol, and insulin levels by the end of treatment, indicating that even modest weight loss can lead to substantial health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of health outcomes to improvement in BMI in children and adolescents. Kirk, S., Zeller, M., Claytor, R., et al.[2013]

The HealthMPowers program effectively improved student knowledge and self-reported behaviors related to health, particularly among third-graders, with significant knowledge gains observed in the second year of the program (p < 0.0001).

The program also led to significant decreases in BMI-for-Age Z scores, especially for students who were overweight or obese at the start, and improved performance on the PACER test, indicating enhanced cardiovascular fitness across all grades (p < 0.0001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A holistic school-based intervention for improving health-related knowledge, body composition, and fitness in elementary school students: an evaluation of the HealthMPowers program. Burke, RM., Meyer, A., Kay, C., et al.[2021]

Citations

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sbm.secure-platform.com/site/gallery/rounds/82001/details/11495

D80 - Adapted Obesity Prevention Intervention in Under- ...

Results: ProudMe Cafeteria demonstrated outstanding implementation outcomes. ... Childhood obesity prevention intervention efforts in under-resourced ...

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(PDF) Testing an adapted obesity prevention intervention ...

Implementation outcomes were less desirable in ProudMe PE with moderate penetration and fidelity. ProudMe PD was well attended but ProudMe Tech ...

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pmc.ncbi.nlm.nih.gov/articles/PMC11999465/

A secondary data analysis of a systematic review - PMC

The aim of this study is to synthesise the effects of child obesity prevention programs on diet, physical activity, tobacco smoking and alcohol intake.

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Testing an adapted obesity prevention intervention in ...

The evaluation of the pilot ProudMe intervention simultaneously examined its implementation and preliminary effectiveness. For implementation ...

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withpower.com

withpower.com/trial/phase-pediatric-obesity-1-2024-9ad8e

ProudMe Program for Childhood Obesity (ProudMe Trial)

A 12-month structured multidisciplinary weight management program for 77 obese children led to a significant reduction in BMI from 25.9 to 24.5 kg/m² and BMI ...

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sciencedirect.com/science/article/pii/S221133552200393X

Outcomes of a 24-month childhood obesity prevention ...

The primary outcome was change in child body mass index (BMI) z-score at 24 months. Secondary outcomes included number of positive child and parent changes in ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4561621/

What childhood obesity prevention programmes work? A ...

None of the home-based studies reported statistically significant favourable results. One out of three (33%) primary care-based studies, two out of five (40%) ...