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H-PACE Program for the Improvement of Lifestyle Behaviors Among Children

Fred Hutchinson Cancer Center (FHCC) logo

Fred Hutchinson Cancer Center (FHCC)

Status

Invitation-only

Conditions

Pediatric Obesity

Treatments

Behavioral: H-PACE Behavioral Intervention
Other: Questionnaire Administration
Other: Accelerometer
Other: Supportive Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06548074
FHIRB0020386 (Other Identifier)
U54CA132381 (U.S. NIH Grant/Contract)
NCI-2024-05449 (Registry Identifier)
RG1124059

Details and patient eligibility

About

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.

Full description

OUTLINE:

Children attend the H-PACE program comprising educational lessons over 30 minutes, PA over 30 minutes, and healthy snacks twice a week (BIW) for 12 weeks. The educational component includes 30-minute lessons on PA, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) comprises a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component introduces children to tasty and healthy foods and teaches children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Children prepare healthy snack foods at home with parents once a week (QW) by taking home fruit and vegetable boxes with recipes for family-based engaging activities. Children also wear an accelerometer to monitor activity for 7 days at baseline and during week 11-12. Parents may participate in an optional virtual peer support group on study.

Enrollment

120 estimated patients

Sex

All

Ages

8+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Children in 3rd - 5th grade, 8-11 years of age, attending the afterschool program at the selected elementary schools.
  • Parents/Guardians of the eligible child, who are ≥ 18 years old.
  • Fluency in English or Spanish.

Exclusion criteria

  • Children who are not in 3rd - 5th grade.
  • Children not attending the afterschool program at the selected elementary schools.
  • Parents/Guardians of the eligible child, who are < 18 years old.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Prevention (H-PACE program)
Experimental group
Description:
See Detailed Description.
Treatment:
Other: Supportive Care
Other: Accelerometer
Other: Questionnaire Administration
Behavioral: H-PACE Behavioral Intervention

Trial contacts and locations

2

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Central trial contact

Jason Mendoza, MD, MPH

Data sourced from clinicaltrials.gov

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