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

Multicenter Pilot Project to Test the Healthy Parents and Children Enhancement (H-PACE) Program

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: H-PACE Behavioral Intervention; Other: Accelerometer; Other: Supportive Care

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Las Cruces, New Mexico, United States, 88003
      • New Mexico State University
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prevention (H-PACE program); See Detailed Description.

Other: Questionnaire Administration; Ancillary studies; Behavioral: H-PACE Behavioral Intervention; Participate in the H-PACE program; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Other: Accelerometer; Wear an accelerometer; Other: Supportive Care; Parents may participate in an optional virtual peer support group; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); New Mexico State University
• Investigators: Principal Investigator: Dejan Magoc, PhD, New Mexico State University; Principal Investigator: Jason Mendoza, MD, MPH, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: August 5, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: sleep; fruit; vegetable; sedentary activity; physical activity (exercise)
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: RG1124059; U54CA132381 (U.S. NIH Grant/Contract); NCI-2024-05449 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); FHIRB0020386 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No