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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study proposes a randomized pilot and feasibility study of a lifestyle modification program to promote healthy diet and activity in rural-dwelling children to reduce Type 2 Diabetes risks. Intervention participants will receive 6 months of programming to include: * 16 activity packs; * 9 health coach sessions; * unlimited access to a resource toolbox. Control participants will receive 6 activity packs promoting science, technology, engineering, and math (STEM) learning and 6 check-in calls to support retention.

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.

Is the Healthy Lifestyle Program for Childhood Obesity safe for children?

The research on similar family-based and community-based programs for childhood obesity, like Kids N Fitness and Go4Fun, suggests that these programs are generally safe for children. They focus on healthy eating, physical activity, and behavioral changes, which are beneficial for children's health. ^{1 2 3 4 5}

How is the Bennett Kids PowerUP Project treatment different from other treatments for childhood obesity?

The Bennett Kids PowerUP Project is unique because it focuses on a healthy lifestyle program that is family-centered and hospital-based, aiming to reduce weight gain in overweight children by involving their families in the process. This approach is different from other treatments that may focus solely on the child or use school-based interventions. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment Bennett Kids PowerUP Project for childhood obesity?

Research shows that family-based programs focusing on healthy eating and physical activity can help reduce weight in obese children. For example, a study found that children in a family-based program lost an average of 2.3 kg over 12 weeks. Additionally, school-based interventions that include both diet and physical activity components have been shown to be effective in preventing childhood obesity. ^{1 3 4 9 10}

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]

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]

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]

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]

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]

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]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Feasibility of a hospital-based, family-centered intervention to reduce weight gain in overweight children and adolescents. [2021]

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

"Energy Up": a novel approach to the weight management of inner-city teens. [2009]

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

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. [2019]

4. England pubmed.ncbi.nlm.nih.gov

What childhood obesity prevention programmes work? A systematic review and meta-analysis. [2023]

5. India pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. [2022]

6. England 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. [2020]

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

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

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Project Energize: intervention development and 10 years of progress in preventing childhood obesity. [2021]

10. Switzerland 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. [2022]