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

NCT06548074 | Completed

• 4 other identifiers: RG1124059NCI-2024-05449U54CA132381FHIRB0020386
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediatric Obesity

Keywords

physical activity (exercise); sedentary activity; sleep; fruit; vegetable

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Prevention (H-PACE program)

EXPERIMENTAL

See Detailed Description.

Behavioral: H-PACE Behavioral Intervention; Other: Accelerometer; Other: Questionnaire Administration; Other: Supportive Care

Interventions

H-PACE Behavioral Intervention BEHAVIORAL

Participate in the H-PACE program

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Prevention (H-PACE program)

Accelerometer OTHER

Wear an accelerometer

Prevention (H-PACE program)

Questionnaire Administration OTHER

Ancillary studies

Prevention (H-PACE program)

Supportive Care OTHER

Parents may participate in an optional virtual peer support group

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Prevention (H-PACE program)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• New Mexico State University: collaborator

Study Sites (2)

New Mexico State University

Las Cruces, New Mexico, 88003, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Interventions

Behavior Therapy; Palliative Care

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jason Mendoza, MD, MPH

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

• Dejan Magoc, PhD

  New Mexico State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 12, 2024
• Study Start: January 22, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)