- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06548074
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prevention (H-PACE program)
See Detailed Description.
|
Ancillary studies
Participate in the H-PACE program
Other Names:
Wear an accelerometer
Parents may participate in an optional virtual peer support group
Other Names:
|
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)
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.
|
Up to week 14
|
|
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.
|
Up to week 14
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Obesity
- Pathological Conditions, Signs and Symptoms
- Behavior
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Pediatric Obesity
- Motor Activity
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Psychotherapy
- Behavioral Disciplines and Activities
- Palliative Care
- Behavior Therapy
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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