Clinical trial NCT05563506: The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices
Official title: The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Keywords: physical activity
dietary intake
use of technology
sleep
Lead sponsor: New Mexico State University
Sponsor class: OTHER
Collaborators: name: Fred Hutch
First posted: 2022-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years.

Detailed description: The purpose of this study is to implement and evaluate the Healthy Kids+ initiative -- a community-engaged research project - through an existing after-school program in Las Cruces, NM. The Healthy Kids+ initiative will encourage daily lifestyle behaviors (5 or more servings of fruits and vegetables, 2 hours or less of recreational screen time, 1 hour of physical activity, 0 sugary drinks, 10 hours of sleep) that impact childhood obesity. This research project will integrate lessons and activities designed to help kids incorporate changes into their lives to enhance their health and wellness. Overall, it is expected that children participating in the Healthy Kids+ initiative, three times per week, will demonstrate significant changes in improving lifestyle behaviors and maintaining both cognitive and affective changes.Healthy Kids+ will be integrated into the 21st Century afterschool program to provide children at the school sites with relevant PA and health related programming throughout the year. The proposed study will include a repeated-measures research design. A power analysis revealed that for a moderate effect size (f = .25, Cohen, 1988), with five percent type I error and 80% power, three follow up time points, and within subject's correlation of 0.5, we will need to recruit at a minimum 100 total participants. However, our potential participant pool is much larger, and thus we plan on over recruiting (N = 200) to mitigate lost data from attrition rates. The Healthy Kids+ program will be implemented three times a week for 30 weeks. A midyear assessment will be conducted 15-weeks into the program. Participants will then take part in a post assessment at the completion of the 30-week program. The primary quantitative outcome measures include levels of lifestyle behaviors (PA, healthy eating habits, screen time, sleep). The outcome measures will also include self-efficacy, self-esteem, and the level of readiness to change relevant to aforementioned lifestyle behaviors.

Based on Healthy Kids+, we revised and partnered with Fred Hutchinson Cancer Center to expand this trial. For this follow up project, we will recruit 30 children total at NMSU. For this follow up project, we will use accelerometer to objectively measure physical activity and sleep, as well as validated surveys measures for dietary intake and related health outcomes.

Eligibility criteria: Inclusion Criteria:

* Children ages 8-11 years enrolled in the after-school program at the selected sites.

Exclusion Criteria:

* Children not enrolled in the after-school program at the selected sites.

Primary outcomes:
measure: After-School Student Questionnaire (ASSQ)
timeFrame: 2 weeks
Secondary outcomes:
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: 1 week
measure: Physical Activity Questionnaire for Children (PAQ-C)
timeFrame: 1 week
Other outcomes:
measure: 5-2-1-0 Healthy Habits Questionnaire
timeFrame: 2 weeks
measure: Accelerometer
timeFrame: 2 weeks
measure: H-PACE Survey
timeFrame: 2 weeks
Locations:
city: Las Cruces
country: United States
facility: Loma Heights Elementary School
state: New Mexico
city: Las Cruces
country: United States
facility: University Hills Elementary
state: New Mexico
Study officials:
affiliation: New Mexico State University
name: Dejan Magoc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutch
name: Jason Mendoza, PhD
role: PRINCIPAL_INVESTIGATOR
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