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

NCT ID: NCT06548074

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-05-30

Brief Summary

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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

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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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prevention (H-PACE program)

See Detailed Description.

Group Type EXPERIMENTAL

H-PACE Behavioral Intervention

Intervention Type BEHAVIORAL

Participate in the H-PACE program

Accelerometer

Intervention Type OTHER

Wear an accelerometer

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type OTHER

Parents may participate in an optional virtual peer support group

Interventions

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H-PACE Behavioral Intervention

Participate in the H-PACE program

Intervention Type BEHAVIORAL

Accelerometer

Wear an accelerometer

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Supportive Care

Parents may participate in an optional virtual peer support group

Intervention Type OTHER

Other Intervention Names

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Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

New Mexico State University

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Mendoza, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Dejan Magoc, PhD

Role: PRINCIPAL_INVESTIGATOR

New Mexico State University

Locations

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New Mexico State University

Las Cruces, New Mexico, United States

Site Status

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2024-05449

Identifier Type: REGISTRY

Identifier Source: secondary_id

U54CA132381

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FHIRB0020386

Identifier Type: OTHER

Identifier Source: secondary_id

RG1124059

Identifier Type: -

Identifier Source: org_study_id

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