H-PACE Program for Childhood Obesity

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called H-PACE to determine if it can help children make healthier lifestyle choices, such as eating more fruits and vegetables and reducing screen time. The goal is to discover if these habits can lower the risk of obesity and related diseases like diabetes and heart disease. The program involves children in 3rd to 5th grade who attend specific afterschool programs, along with their parents. It encourages families to work together to form healthy habits that can last a lifetime. As an unphased trial, this study offers families a unique opportunity to actively participate in research that could positively impact their 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 the H-PACE program is safe for children?

Research has shown that the H-PACE program, which manages childhood obesity through lifestyle and behavior changes, is generally safe. The program encourages healthy habits such as eating more fruits and vegetables, reducing screen time, and getting enough exercise and sleep. Studies have found that similar family-based programs are well-received, with participants typically not reporting any major side effects. However, individual experiences may vary with any lifestyle change.

Because the program focuses on promoting healthier daily habits, the risks remain low. The goal is to foster gradual and lasting lifestyle changes. Participants and their families can expect a supportive environment aimed at improving overall health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the H-PACE Behavioral Intervention for childhood obesity because it offers a fresh approach to tackling this condition. Unlike traditional treatments that often focus on medication or dietary restrictions, H-PACE emphasizes a comprehensive behavioral strategy that can be tailored to each child's needs. By focusing on sustainable lifestyle changes and family involvement, this program aims to create lasting habits rather than temporary solutions. This innovative approach has the potential to empower children and their families to achieve healthier outcomes in a supportive and engaging way.

What evidence suggests that the H-PACE program is effective for improving lifestyle behaviors in children?

Research shows that programs involving both parents and children can help kids make healthier choices. Past studies have linked organized programs focusing on behavior to less disordered eating and slower weight gain in children. Although some school programs did not significantly change BMI (Body Mass Index), involving families appears to improve results. In this trial, participants will follow the H-PACE program, which emphasizes daily habits like eating more fruits and vegetables, reducing screen time, and exercising regularly. This approach focuses on lifestyle changes, which are important for preventing obesity and related health problems. ^{2 6 7 8 9}

Who Is on the Research Team?

Dejan Magoc, PhD

Principal Investigator

New Mexico State University

Jason Mendoza, MD, MPH

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-pediatric-obesity-8-2024-8d77b

H-PACE Program for Childhood Obesity · Info for Participants This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10586458/

Evidence Base Update on Behavioral Treatments for ... Research has found that participation in structured, behavioral weight loss treatment can reduce symptoms of disordered eating in children with overweight or ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0091743521003911

Efficacy of a school-based physical activity and nutrition ... There were no significant effects of the nutrition or physical activity intervention on child BMI scores or child quality of life, and no significant ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/oby.22329

Reduced Eating Pace (RePace) Behavioral Intervention for ... Children in RePace compared with DUC showed increased “slowness in eating” (P < 0.001), increased food enjoyment (P = 0.04), and less BMI gain ( ...

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD015328.pub2/full

Interventions to prevent obesity in children aged 5 to 11 ... Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06548074

Study Details | NCT06548074 | H-PACE Program for the ... This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9664376/

Implementing family-based behavioral treatment in the ... The goal of this study is to assess effectiveness of FBT implemented in pediatric primary care settings using newly trained interventionists.

8. tandfonline.com tandfonline.com/doi/full/10.1080/15374416.2023.2251164

Evidence Base Update on Behavioral Treatments for ... This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624002967

PACE: a Novel Eating Behavior Phenotype to Assess Risk ... PACE represents a cumulative eating behavior risk score that predicts adiposity gain over 1 y in middle childhood.