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

NCT ID: NCT05563506

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-23

Study Completion Date

2025-07-30

Brief Summary

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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

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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.

Conditions

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Health Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy Kids +

Three times a week for 30 weeks with each session lasting 1 hour.

Group Type EXPERIMENTAL

Healthy Kids +

Intervention Type BEHAVIORAL

Three times a week for 30 weeks.

Interventions

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Healthy Kids +

Three times a week for 30 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fred Hutch

UNKNOWN

Sponsor Role collaborator

New Mexico State University

OTHER

Sponsor Role lead

Responsible Party

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Dejan Magoc

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dejan Magoc, PhD

Role: PRINCIPAL_INVESTIGATOR

New Mexico State University

Jason Mendoza, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch

Locations

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Loma Heights Elementary School

Las Cruces, New Mexico, United States

Site Status

University Hills Elementary

Las Cruces, New Mexico, United States

Site Status

Countries

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United States

References

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Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.

Reference Type BACKGROUND
PMID: 10925833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3432232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12054320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2786559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15877906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11145319 (View on PubMed)

Other Identifiers

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2U54CA132383-16 5016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2U54CA132383-16

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22769 / 220600102

Identifier Type: -

Identifier Source: org_study_id

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