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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06548074
Enrollment
122
Registered
2024-08-12
Start date
2024-01-22
Completion date
2025-05-30
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

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

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.

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.

Interventions

BEHAVIORALH-PACE Behavioral Intervention

Participate in the H-PACE program

OTHERAccelerometer

Wear an accelerometer

OTHERQuestionnaire Administration

Ancillary studies

OTHERSupportive Care

Parents may participate in an optional virtual peer support group

Sponsors

Fred Hutchinson Cancer Center
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
New Mexico State University
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility)Up to week 14Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.
Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility)Up to week 14Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJason Mendoza, MD, MPH

Fred Hutch/University of Washington Cancer Consortium

PRINCIPAL_INVESTIGATORDejan Magoc, PhD

New Mexico State University

Participant flow

Recruitment details

Recruitment occurred in 2 elementary schools in the Central Valley of WA state and 2 elementary schools in Las Cruces, NM. The New Mexico research team leveraged existing relationship with after-school program to identify schools to participate in this study. WA research team worked with district superintendent to identify 2 schools. Recruitment flyers were disseminated at each school, and research staff attended parent meetings to present the study and answer questions.

Pre-assignment details

N/A; Single arm intervention to test feasibility. Prior to start of intervention 22 parent-child dyads in New Mexico and 39 parent-child dyads in Central Washington were recruited and completed informed consent/assent, for a total of 122 participants. Of those, 121 (60 parents and 61 children) completed a baseline survey.

Baseline characteristics

Characteristic
Age, Continuous
Kids
10 Years
STANDARD_DEVIATION 0.96
Age, Continuous
Parents
39 Years
STANDARD_DEVIATION 9.1
Ethnicity (NIH/OMB)
Kids
Hispanic or Latino
57 Participants
Ethnicity (NIH/OMB)
Kids
Not Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Kids
Unknown or Not Reported
1 Participants
Ethnicity (NIH/OMB)
Parents
Hispanic or Latino
55 Participants
Ethnicity (NIH/OMB)
Parents
Not Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Parents
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
Kids
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Kids
Asian
0 Participants
Race (NIH/OMB)
Kids
Black or African American
4 Participants
Race (NIH/OMB)
Kids
More than one race
1 Participants
Race (NIH/OMB)
Kids
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Kids
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
Kids
White
51 Participants
Race (NIH/OMB)
Parents
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Parents
Asian
0 Participants
Race (NIH/OMB)
Parents
Black or African American
4 Participants
Race (NIH/OMB)
Parents
More than one race
0 Participants
Race (NIH/OMB)
Parents
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Parents
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
Parents
White
52 Participants
Sex: Female, Male
Kids
Female
35 Participants
Sex: Female, Male
Kids
Male
25 Participants
Sex: Female, Male
Parents
Female
51 Participants
Sex: Female, Male
Parents
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026