Healthy Lifestyle Program for Childhood Obesity

Overseen By Cristel Castelo

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Diabetes, Serious health concerns, others

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

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a healthy lifestyle program, the Bennett Kids PowerUP Project, can reduce the risk of Type 2 Diabetes in children by promoting a balanced diet and regular physical activity. Participants in the intervention group will engage in activities and receive coaching sessions, while the control group will focus on STEM learning. The trial targets children aged 7 to 10 living in rural areas of Colorado or North Carolina, with a parent willing to participate. As an unphased trial, it offers families a unique opportunity to contribute to research that could enhance children's health and well-being.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this lifestyle modification program is safe for children?

Research shows that the Kids PowerUP program, part of the Bennett Kids PowerUP Project, is generally safe for children. Studies have found that kids in similar programs have improved their eating and exercise habits. These programs aim to lower the risk of obesity and boost overall health by encouraging better diet and physical activity.

Although specific data on side effects is not available, the program's focus on lifestyle changes, such as healthier eating and increased activity, suggests it is well-tolerated. No reports of serious problems have been linked to these types of programs. The goal is to make healthy lifestyle choices easier and more accessible for children, especially those in rural areas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bennett Kids PowerUP Project because it takes a holistic approach to tackling childhood obesity. Unlike standard treatments that often focus solely on diet or exercise, this program combines physical activity and healthy eating habits through interactive, parent-guided activity kits and personalized, one-on-one health coaching. This dual approach not only engages children but also educates and involves parents, potentially leading to more sustainable lifestyle changes. Additionally, the unlimited access to a resource toolbox provides ongoing support, making it more comprehensive than typical interventions. The focus on family involvement and personalized coaching is what sets this program apart from traditional methods.

What evidence suggests that the Bennett Kids PowerUP Project is effective for reducing Type 2 Diabetes risks in children?

The current trial, the Bennett Kids PowerUP Project, aims to help children, especially those in rural areas, improve their eating and exercise habits. Participants in the intervention group will receive approximately 25 hours of programming focused on promoting physical activity and a healthy diet. Earlier programs, such as the Power-Up after-school program, have successfully reduced obesity risk by involving the community. These initiatives encourage kids to be more active and eat healthier, which are important for lowering the risk of Type 2 Diabetes. Evidence from similar projects suggests that structured guidance and resources can positively change children's health habits. Overall, these programs have shown promise in helping kids adopt healthier lifestyles. ^{1 2 6 7 8}

Who Is on the Research Team?

Katherine A Sauder, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for children aged 7 to 10 living in Bennett, Colorado. They must speak English or Spanish and have a parent or caregiver willing to participate. It's designed for those at risk of childhood obesity and Type 2 Diabetes.

Inclusion Criteria

I live in Bennett, Colorado.

I am between 7 and 10 years old.

I have one parent or primary caregiver who is willing to actively participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive approximately 25 hours of programming over 6 months, including 16 activity packs, 9 health coach sessions, and unlimited access to a resource toolbox

6 months

9 visits (in-person or virtual)

Control

Control participants receive 6 activity packs promoting STEM learning and 6 check-in calls to support retention

6 months

6 calls (virtual)

Follow-up

Participants are monitored for changes in physical activity, screen time, dietary intake, and other health metrics

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Bennett Kids PowerUP Project

Trial Overview

The study tests a lifestyle program called the Bennett Kids PowerUP Project aimed at promoting healthy eating and activity among rural kids. Participants will get health coach sessions, activity packs, and resources over six months.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Intervention participants will receive approximately 25 hours of programming (over a 6-month period) related to the promotion of physical activity and healthy diet through: 1. 16 self-contained, parent-guided activity kits, 2. 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, 3. unlimited access to a resource toolbox.

Group II: Control Group Active Control 1 Intervention

Control group programming consists of: 1. 6 parent-guided activity kits focused on STEM activities, 2. 6 monthly check-in calls to support retention. The investigators will use Home Science Lab STEM kits designed for English- and Spanish-speaking children aged 6-11 years. The STEM kits do not include any physical health content. Kits will be mailed monthly to the participants' home. To maximize retention in the control group, staff will contact participants each month to confirm the kit was received, encourage completion of the kits, ask about their experience, and answer questions.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

The Kids N Fitness program, which included 12 interactive sessions focused on nutrition and exercise, effectively reduced weight and BMI in 264 overweight children aged 7-17, showing better results compared to a 6-month pre-program observation period.

Improvements in emotional well-being and behavior were positively linked to weight loss, indicating that family-centered lifestyle interventions can enhance both physical and psychological health in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a hospital-based, family-centered intervention to reduce weight gain in overweight children and adolescents. Dreimane, D., Safani, D., MacKenzie, M., et al.[2021]

Project Energize, a physical activity and nutrition program in New Zealand, has successfully operated for over 10 years, showing effectiveness in reducing childhood obesity and improving physical fitness among 53,000 children across 242 primary schools.

The program is cost-effective, with health-related costs estimated between $18,000 and $30,000 per quality-adjusted life year, making it a sustainable model for promoting children's health that can be adapted to various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project Energize: intervention development and 10 years of progress in preventing childhood obesity. Rush, E., Cairncross, C., Williams, MH., et al.[2021]

The Healthy Lifestyles Programme (HeLP) is a school-based obesity prevention initiative designed to engage children and their families through relational approaches, aiming to create supportive environments for healthy lifestyle changes.

An exploratory trial indicated that HeLP is feasible and acceptable, showing potential to change behaviors and positively impact weight status among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healthy Lifestyles Programme (HeLP)--an overview of and recommendations arising from the conceptualisation and development of an innovative approach to promoting healthy lifestyles for children and their families. Lloyd, J., Wyatt, K.[2022]

The 'Energy Up' program effectively helped inner-city girls lose weight, with obese participants losing an average of 12.9 pounds and overweight participants losing 2.9 pounds over a 9-month period.

The program's focus on avoiding addictive foods, promoting exercise, and building self-esteem contributed to its success, leading to plans for expansion to other schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Energy Up": a novel approach to the weight management of inner-city teens. Chehab, LG., Pfeffer, B., Vargas, I., et al.[2009]

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]

Childhood obesity is a major health issue in the U.S., affecting 32.2% of children and adolescents aged 2 to 19, with significant rates of obesity and extreme obesity reported between 2011-2014.

Implementing healthful lifestyle behaviors, including improved nutrition and increased physical activity, is crucial for reducing the risk of chronic diseases like obesity and diabetes in children, highlighting the need for effective community-based interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Healthy Living Medicine, With a Focus on K-12, Physical Education, and Nutrition. Wong, SS.[2019]

In a 12-week family-based program called Building Healthy Families, 22 obese children lost an average of 2.3 kg, while their parents lost an average of 6.4 kg, indicating the program's effectiveness in promoting weight loss for both children and parents.

The study found that reducing the intake of high-fat, high-calorie foods was a strong predictor of weight loss in children, highlighting the importance of dietary changes in successful obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. Ruebel, ML., Heelan, KA., Bartee, T., et al.[2019]

A systematic review of 139 intervention studies found strong evidence that school-based programs focusing on physical activity, especially those involving home participation, are effective in preventing childhood obesity.

Moderate evidence supports combined diet and physical activity interventions in schools, while evidence for interventions in childcare or home settings is low, indicating a need for more research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What childhood obesity prevention programmes work? A systematic review and meta-analysis. Wang, Y., Cai, L., Wu, Y., et al.[2023]

School-based interventions can lead to long-term positive health behavior changes in children, as they spend a significant amount of time in school, although their impact on weight measures is less clear due to common limitations.

Family-based interventions are effective in influencing children's behaviors, but issues like selection bias and high dropout rates can affect the reliability of their results; thus, a multidisciplinary approach that includes both school and family involvement is recommended for managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. Kelishadi, R., Azizi-Soleiman, F.[2022]

In a study of 3090 overweight and obese children participating in the Go4Fun program, attending at least five sessions led to significant improvements in BMI z-score, fruit and vegetable intake, and physical activity levels.

Children whose mothers had lower educational qualifications showed less improvement in BMI and vegetable intake, but those attending seven or more sessions had better outcomes, highlighting the importance of both session attendance and maternal education in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose response relationship between program attendance and children's outcomes in a community based weight management program for children and their families. Khanal, S., Choi, L., Innes-Hughes, C., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3601906/

Power-Up: A Collaborative After-School Program to ...

Power-Up, an after-school program to decrease obesity risk among African American children, using community-based participatory research (CBPR) principles.

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researchgate.net

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This research examines the practice of community coaching within coalitions in the Communities Preventing Childhood Obesity project.

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pmc.ncbi.nlm.nih.gov/articles/PMC10887674/

Treating Children and Adolescents with Obesity

Pediatric weight-loss programs seem to yield moderate effectiveness and not all interventions demonstrate favorable outcomes. This could be ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/22616204/

a collaborative after-school program to prevent obesity in ...

Children in the Power-Up program reduced mean BMI z scores significantly. The after-school venue proved feasible. The use of CBPR principles helped to ...

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onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/obr.13692

Spillover effects of childhood obesity prevention ...

Results. Twenty academic studies and 41 trial records were included in the synthesis. The most commonly reported spillovers were diet or ...

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nam.edu

nam.edu/wp-content/uploads/2017/01/A-Model-Framework-That-Integrates-Community-and-Clinical-Systems-for-the-Prevention-and-Management-of-Obesity-and-Other-Chronic-Diseases.pdf

A-Model-Framework-That-Integrates-Community-and- ...

Evidence suggests that this program is associated with positive changes in food and physical activity behavior among targeted children (Rogers ...