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Completed

NCT Number: NCT06548074

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

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.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Mexico State University, Las Cruces, New Mexico, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

H-PACE Behavioral Intervention

Behavioral

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

Accelerometer

Other

Wear an accelerometer

Questionnaire Administration

Other

Ancillary studies

Supportive Care

Other

Parents may participate in an optional virtual peer support group

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Primary outcomes

  1. Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility)

    Time frame: 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.

  2. Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • New Mexico State University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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