- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05563506
The Healthy Kids+ Initiative: Promoting Active Living Through Healthy Choices
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
New Mexico
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Las Cruces, New Mexico, United States, 88001
- Loma Heights Elementary School
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Las Cruces, New Mexico, United States, 88001
- University Hills Elementary
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Healthy Kids +
Three times a week for 30 weeks with each session lasting 1 hour.
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Three times a week for 30 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 week
|
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Physical Activity Questionnaire for Children (PAQ-C)
Time Frame: 1 week
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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.
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1 week
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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2 weeks
|
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Accelerometer
Time Frame: 2 weeks
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physical activity and sleep
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2 weeks
|
|
H-PACE Survey
Time Frame: 2 weeks
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demographics, physical activity, dietary intake, screen time, sleep
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2 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dejan Magoc, PhD, New Mexico State University
- Principal Investigator: Jason Mendoza, PhD, Fred Hutch
Publications and helpful links
General Publications
- Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
- Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
- Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Rovniak LS, Anderson ES, Winett RA, Stephens RS. Social cognitive determinants of physical activity in young adults: a prospective structural equation analysis. Ann Behav Med. 2002 Spring;24(2):149-56. doi: 10.1207/S15324796ABM2402_12.
- Steinhardt MA, Dishman RK. Reliability and validity of expected outcomes and barriers for habitual physical activity. J Occup Med. 1989 Jun;31(6):536-46. doi: 10.1097/00043764-198906000-00011.
- Kelder S, Hoelscher DM, Barroso CS, Walker JL, Cribb P, Hu S. The CATCH Kids Club: a pilot after-school study for improving elementary students' nutrition and physical activity. Public Health Nutr. 2005 Apr;8(2):133-40. doi: 10.1079/phn2004678.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22769 / 220600102
- 2U54CA132383-16 5016 (Other Grant/Funding Number: National Institutes Of Health)
- 2U54CA132383-16 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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