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

480 Participants Needed

Trial Summary

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 data supports the effectiveness of the ProudMe treatment for childhood obesity?

Research shows that structured programs, like the ProudMe treatment, can help improve weight and self-esteem in children with obesity. Programs that involve multiple approaches, such as diet, exercise, and behavioral support, have been effective in reducing BMI and improving health outcomes in children. ^{1 2 3 4 5}

Is the ProudMe Program for Childhood Obesity safe for children?

There is no specific safety data available for the ProudMe Program, but similar community-based programs like Fit2Play™ have been implemented without reported safety issues, focusing on improving health outcomes in children. ^{3 6 7 8 9}

How is the ProudMe treatment for childhood obesity different from other treatments?

The ProudMe Program for Childhood Obesity is unique because it focuses on a comprehensive approach that likely includes lifestyle modifications, similar to other programs like CEMHaVi and Project Healthy Schools, which emphasize health education and physical activity. This holistic approach may differ from standard treatments that often focus solely on diet or exercise. ^{8 10 11 12 13}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The relationship of health outcomes to improvement in BMI in children and adolescents. [2013]

2. Germany 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An innovative summer camp program improves weight and self-esteem in obese children. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A pediatric weight management program for high-risk populations: a preliminary analysis. [2009]

5. England pubmed.ncbi.nlm.nih.gov

Two-year effects of the community-based overweight and obesity intervention program Gezond Onderweg! (GO!) in children and adolescents living in a low socioeconomic status and multi-ethnic district on Body Mass Index-Standard Deviation Score and quality of life. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of participation in a park-based afterschool program on cardiovascular disease risk among severely obese youth. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Canadian Pediatric Weight Management Registry (CANPWR): baseline descriptive statistics and comparison to Canadian norms. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of a park-based afterschool program replicated over five years on modifiable cardiovascular disease risk factors. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary outcomes of a scalable, community-based treatment of childhood obesity. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

The CEMHaVi program: control, evaluation, and modification of lifestyles in obese youth. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Top 10 Lessons Learned from Project Healthy Schools. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Park-based obesity intervention program for inner-city minority children. [2015]

13. England 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. [2021]