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

Not Applicable

Active, not recruiting

• Conditions: Pediatric Obesity
• Interventions: Behavioral: H-PACE Behavioral Intervention; Other: Accelerometer; Other: Questionnaire Administration; Other: Supportive Care

• Registration Number: NCT06548074
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-22
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (H-PACE program)	Questionnaire Administration	See Detailed Description.
Prevention (H-PACE program)	Supportive Care	See Detailed Description.
Prevention (H-PACE program)	H-PACE Behavioral Intervention	See Detailed Description.
Prevention (H-PACE program)	Accelerometer	See Detailed Description.

Primary Outcome Measures

Name	Time	Method
Percentage of children who attended more than 75% of program sessions (Feasibility)	Up to week 14	Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.
Percentage of children who completed more than 80% of assessment activities (Feasibility)	Up to week 14	Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.

Trial Locations

Locations (2)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

New Mexico State University; 🇺🇸 Las Cruces, New Mexico, United States