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Completed

NCT Number: NCT05563506

The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices

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.

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Key information

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Heights Elementary School, Las Cruces, New Mexico, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Kids +

Behavioral

Three times a week for 30 weeks.

Primary outcomes

  1. After-School Student Questionnaire (ASSQ)

    Time frame: 2 weeks

    A self-administered questionnaire that measures the behavioral and psychosocial variables targeted by the intervention. ASSQ survey items were modified from the Health Behavior Questionnaire and the School-Based Nutrition Monitoring Student Questionnaire, both of which have been found to have acceptable internal consistency (greater than 0.6). Measured constructs in the ASSQ included: food preferences, dietary knowledge, self-efficacy, intentions to choose healthful food options, and participation in sedentary and sports activities.

Secondary outcomes

  1. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: 1 week

    A parent-rated questionnaire that assesses the frequency of behaviors associated with common pediatric sleep difficulties. A retrospective measure, the CSHQ instructs parents to rate the frequency with which their child has displayed various sleep behaviors during the previous week.

  2. Physical Activity Questionnaire for Children (PAQ-C)

    Time frame: 1 week

    A self-administered, 7-day recall instrument, developed to assess general levels of physical activity for students in grades 4 to 8 and approximately 8 to 14 years of age.

Other outcomes

  1. 5-2-1-0 Healthy Habits Questionnaire

    Time frame: 2 weeks

    A brief 10-question survey for children ages 2-14 used to collect information about individuals' healthy habits, specifically habits related to diet, physical activity, screen time, and sleep.

  2. Accelerometer

    Time frame: 2 weeks

    physical activity and sleep

  3. H-PACE Survey

    Time frame: 2 weeks

    demographics, physical activity, dietary intake, screen time, sleep

Sponsors and collaborators

Lead sponsor

New Mexico State University

Other

Collaborators

  • Fred Hutch

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2022
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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