H-PACE Program for Childhood Obesity

Recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Not in 3rd-5th grade, others

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

Compensation: Varies

Number of Visits: 24

122 Participants Needed

Trial Summary

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 data supports the effectiveness of the H-PACE Behavioral Intervention treatment for childhood obesity?

Research shows that programs focusing on behavior change, nutrition education, and physical activity can help children lose weight and improve their health. For example, a school-based program led to significant weight loss in children, and family-based programs have shown improvements in diet and activity levels. ^{1 2 3 4 5}

Is the H-PACE Program for Childhood Obesity safe for children?

The H-PACE Program, which focuses on behavior and lifestyle changes for managing childhood obesity, is generally considered safe. However, like other obesity treatments, it may have potential side effects such as changes in eating patterns, so it's important to monitor these aspects during the program. ^{1 6 7 8 9}

How does the H-PACE Behavioral Intervention treatment for childhood obesity differ from other treatments?

The H-PACE Behavioral Intervention is unique because it focuses on a family-based approach, involving both children and their families in behavior modification to address childhood obesity. This approach is similar to other programs like C.H.A.M.P. and Building Healthy Families, which also emphasize family involvement, but H-PACE may have specific components or strategies that set it apart, such as its particular schedule, activities, or educational sessions. ^{2 10 11 12 13}

What is the purpose of this trial?

This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Together, they can decrease the risk of developing obesity as well as related diseases such as diabetes, heart disease, stroke, and several types of cancer. To address the prevalence of obesity and related diseases, programs focusing on increasing opportunities for active living and healthy eating are necessary. Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits; however, most afterschool programs are short term; evidence is needed to confirm long-term effects. Moreover, programs that involve parents have shown to be more successful in helping children choose healthier behaviors. Unfortunately, due to technological advancement, opportunities for children to be active in schools have become more limited in modern society. H-PACE program is based on the national childhood obesity prevention campaign designed to help families, schools, communities, and physicians to raise awareness of nutritional and PA daily guidelines. The H-PACE will encourage daily lifestyle behaviors (five or more servings of fruits and vegetables, two hours or less of recreational screen time, one hour of PA, zero sugary drinks, ten hours of sleep) that impact childhood obesity. This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children.

Research Team

Jason Mendoza, MD, MPH

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Dejan Magoc, PhD

Principal Investigator

New Mexico State University

Eligibility Criteria

This trial is for children struggling with obesity. It's designed to help them improve their eating habits and increase physical activity. To join, kids must be able to follow the program and have parental support. Children who can't commit to the lifestyle changes or have conditions that limit their participation are not eligible.

Inclusion Criteria

I am over 18 and the parent or guardian of the child for the trial.

My child is in 3rd-5th grade, aged 8-11, and attends the afterschool program.

Exclusion Criteria

My child is not in 3rd to 5th grade.

Children not attending the afterschool program at the selected elementary schools

I am the parent/guardian of a child eligible for the trial and I am under 18.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

H-PACE Program

Children attend the H-PACE program comprising educational lessons, physical activity, and healthy snacks twice a week for 12 weeks.

12 weeks

24 visits (in-person)

Follow-up

Participants are monitored for program adherence and completion of assessment activities.

2 weeks

Treatment Details

Interventions

• H-PACE Behavioral Intervention

Trial Overview The H-PACE program being tested aims to encourage healthy behaviors in children, like eating fruits and vegetables, reducing screen time, increasing physical activity, avoiding sugary drinks, and getting enough sleep. The effectiveness of this supportive care intervention will be measured using questionnaires and an accelerometer.

Participant Groups

Group I: Prevention (H-PACE program) Experimental Treatment 4 Interventions

See Detailed Description.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

New Mexico State University

Collaborator

Trials

10

Recruited

2,100+

Findings from Research

Childhood obesity interventions aim to regulate body weight and fat while ensuring proper nutrition for growth, with successful programs leading to healthier eating and exercise behaviors that can persist into adulthood.

While these interventions can lead to positive health outcomes like reduced blood pressure and improved insulin sensitivity, they also carry risks such as the potential development of disordered eating patterns, highlighting the need for careful implementation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pediatric obesity. Epstein, LH., Myers, MD., Raynor, HA., et al.[2007]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

Four years after the Healthy School Start intervention, no significant overall effects on dietary intake, screen time, physical activity, or BMI were found among the entire group of children, indicating limited long-term effectiveness of the program.

However, some subgroup effects were noted: girls showed a lower intake of unhealthy foods, while boys above the 95th percentile had higher BMI in the intervention group, suggesting that the intervention's impact varied by gender and initial weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial. Norman, Å., Zeebari, Z., Nyberg, G., et al.[2023]

This project aims to adapt and evaluate the effectiveness of Physical Activity on Prescription (PAP) for approximately 60 children aged 6 to 12 with obesity, focusing on their physical activity levels and health outcomes over a 12-month period.

The study will assess not only clinical outcomes like BMI and metabolic risk factors but also the feasibility and acceptability of PAP through various implementation metrics, providing insights into how to effectively integrate this intervention into pediatric healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of physical activity on prescription for children with obesity in paediatric health care (IMPA): protocol for a feasibility and evaluation study using quantitative and qualitative methods. Bernhardsson, S., Boman, C., Lundqvist, S., et al.[2022]

In a study of 6454 children and adolescents with obesity, participation in pediatric weight management programs led to a modest median decrease in body mass index (BMI), with significant improvements observed over 12 months.

Factors such as older age (≥12 years), greater severity of obesity, and Hispanic ethnicity were linked to better outcomes in BMI reduction, which also correlated with improvements in cardiometabolic risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. Kumar, S., King, EC., Christison, AL., et al.[2020]

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]

References

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

Treatment of pediatric obesity. [2007]

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

Packaging and Scaling the Stanford Pediatric Weight Control Program: A Family-Based, Group, Behavioral Weight Management Program for Children with Obesity and Their Families: Background, Rationale, and Design of the Stanford CORD 3.0 Project. [2022]

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

A retrospective review of patient outcomes in the pediatric HEROES weight management program. [2019]

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

Pediatric obesity epidemic: treatment options. [2022]

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

A school-based behavior modification, nutrition education, and physical activity program for obese children. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial. [2023]

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

Implementation of physical activity on prescription for children with obesity in paediatric health care (IMPA): protocol for a feasibility and evaluation study using quantitative and qualitative methods. [2022]

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

Health Outcomes of Youth in Clinical Pediatric Weight Management Programs in POWER. [2020]

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

Obesity Management in Children and Adolescents. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Parental perspectives of a 4-week family-based lifestyle intervention for children with obesity. [2021]

11. Israel pubmed.ncbi.nlm.nih.gov

The Downstart Program: a hospital-based pediatric healthy lifestyle program for obese and morbidly obese minority youth. [2022]

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

Use of a FITLINE to Support Families of Overweight and Obese Children in Pediatric Practices. [2016]

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

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