NCT05563506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

September 27, 2022

Last Update Submit

August 26, 2025

Conditions

Keywords

physical activitydietary intakeuse of technologysleep

Outcome Measures

Primary Outcomes (1)

  • After-School Student Questionnaire (ASSQ)

    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 Outcomes (2)

  • Children's Sleep Habits Questionnaire (CSHQ)

    1 week

  • Physical Activity Questionnaire for Children (PAQ-C)

    1 week

Other Outcomes (3)

  • 5-2-1-0 Healthy Habits Questionnaire

    2 weeks

  • Accelerometer

    2 weeks

  • H-PACE Survey

    2 weeks

Study Arms (1)

Healthy Kids +

EXPERIMENTAL

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

Behavioral: Healthy Kids +

Interventions

Healthy Kids +BEHAVIORAL

Three times a week for 30 weeks.

Healthy Kids +

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loma Heights Elementary School

Las Cruces, New Mexico, 88001, United States

Location

University Hills Elementary

Las Cruces, New Mexico, 88001, United States

Location

Related Publications (6)

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

    PMID: 10925833BACKGROUND
  • 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.

    PMID: 3432232BACKGROUND
  • 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.

    PMID: 12054320BACKGROUND
  • 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.

    PMID: 2786559BACKGROUND
  • 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.

    PMID: 15877906BACKGROUND
  • 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.

    PMID: 11145319BACKGROUND

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dejan Magoc, PhD

    New Mexico State University

    PRINCIPAL INVESTIGATOR
  • Jason Mendoza, PhD

    Fred Hutch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 3, 2022

Study Start

January 23, 2023

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Data obtained on all standardized measures at baseline and post intervention will be shared with investigators both internal and external to New Mexico State University. Any type of dissemination of results from the project will not identify individual patients. Access levels will be set to protect subject identification and unique identifiers linked to participant identity will be stripped, (i.e., data will be de-identified).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Access will be made available as soon as the primary analyses are completed and accepted for publication in a professional journal and secondary analyses are completed by the team's investigators.
Access Criteria
Prior to sharing the data, Dr. Magoc (PI) will request a detailed plan for data analysis, the choice of the study sample, and a rationale and significance for the proposal. Prior to releasing the data, the proposal will be reviewed by Dr. Magoc.

Locations