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

Not Applicable

• 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, ...

Detailed Description

OUTLINE:
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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: 2024-09
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 120

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.

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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.

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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