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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563506
• Other study ID #: 22769 / 220600102
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2024
• Source: New Mexico State University
• Contact: Dejan Magoc, PhD
• Phone: 386-507-4000
• Email: dmagoc[@]nmsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 to include children from the Yakima Valley of WA State. For this follow up project, we will recruit 60 children total (50% at NMSU and 50% at Fred Hutch). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Healthy Kids +
Three times a week for 30 weeks.

Locations

Country	Name	City	State
United States	Loma Heights Elementary School	Las Cruces	New Mexico
United States	University Hills Elementary	Las Cruces	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico State University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	5-2-1-0 Healthy Habits Questionnaire	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 weeks
Other	Accelerometer	physical activity and sleep	2 weeks
Other	H-PACE Survey	demographics, physical activity, dietary intake, screen time, sleep	2 weeks
Primary	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	Children's Sleep Habits Questionnaire (CSHQ)	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
Secondary	Physical Activity Questionnaire for Children (PAQ-C)	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.	1 week