Clinical trial NCT06548074: H-PACE Program for the Improvement of Lifestyle Behaviors Among Children
Official title: Multicenter Pilot Project to Test the Healthy Parents and Children Enhancement (H-PACE) Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Keywords: physical activity (exercise)
sedentary activity
sleep
fruit
vegetable
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: New Mexico State University
First posted: 2024-08-12
Enrollment: 122
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of children who attended more than 75% of program sessions (Feasibility)
timeFrame: Up to week 14
measure: Percentage of children who completed more than 80% of assessment activities (Feasibility)
timeFrame: Up to week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Las Cruces
country: United States
facility: New Mexico State University
state: New Mexico
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jason Mendoza, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: New Mexico State University
name: Dejan Magoc, PhD
role: PRINCIPAL_INVESTIGATOR
References: