Comprehensive Versus Traditional Lifestyle Program

THINK (Translational Health in Nutrition and Kinesiology) Junior Edition

Despite recommends that school-based interventions use a comprehensive approach for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a 10-week intervention period.

Study Overview

• Status: Completed
• Conditions: Obesity; Cognitive Function 1, Social; Physical Fitness
• Intervention / Treatment: Behavioral: THINK; Behavioral: SPARK

Detailed Description

Despite recommendations that school-based interventions use a comprehensive approaches for health promotions; most fitness programs exclusively emphasize physical activity. This study compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK) fitness curriculum) on measures of physical fitness, body composition, and executive cognitive function outcomes among 105 predominantly, ethnic minority children (9±1.03 years old) following a 10week intervention period.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• To be eligible for this study, subjects had to be between the ages of eight and 12, enrolled in a YMCA program, and able to participate in physical activity. Parents were provided with information packets regarding project details, a parental consent form, and a child assent form. Once the subjects assented and parents consented, a health questionnaire regarding child's age, gender, race/ethnicity, health history and SES was completed.

Exclusion Criteria:

• Subjects with metabolic, cardiovascular, neuromuscular and psychological disorders and with medications that would interfere with testing results were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THINK; The Translational Health in Nutrition and Kinesiology (THINK) program will have education and fitness sessions lasting two hours, five times a week for a total of 10 weeks. Sessions will include theory, clinical laboratory activities, and physically active games to facilitate a fun environment to enhance physical and health-related fitness, improve nutrition and exercise knowledge and behaviors, and exercise enjoyment and self-confidence.	Behavioral: THINK; The THINK curriculum was based on the principles of exercise physiology and health behaviors. Sessions included educational components, concentrating on physiology, nutrition, laboratory experiences, and structured physical fitness activities.
Active Comparator: SPARK; This The Sports, Play, and Active Recreation for Kids (SPARK) group will receive the traditional YMCA SPARK after-school program. They will undergo the same pre and post testing protocol as the intervention group, but will not receive the THINK program.	Behavioral: SPARK; traditional YMCA program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aerobic Fitness	The National Institute of Medicine Toolbox two-minute Walk Endurance Test was used to measure aerobic fitness	Baseline and 10 Weeks
Change in Grip Strength	Grip strength was measures using a Jamar plus handgrip dynamometer.	Baseline and 10 Weeks
Change in Abdominal Strength	The one-minute curl-up test was used to measure abdominal strength and endurance.	Baseline and 10 Weeks
Change in Lower Body Strength	Lower body strength, specifically for the quadriceps muscle group, was assessed with the wall squat test. A vertical jump test utilizing a Vertec. was used to assess lower body power . The vertical jump test data were used to estimate average power (W) according to the Lewis formula Average Power (W) = √4.9 x mass (kg) x √VJ (m) x 9.81.	Baseline and 10 Weeks
Change in Percent Body Fat	Body composition and body fat was measured using the Inbody-520 multi-frequency bioimpedance analyzer.	Baseline and 10 Weeks
Change in BMIz	A CDC growth chart statistical resource was used to calculate BMIz using height, weight, age, and gender.	Baseline and 10 Weeks
Change in Visceral Abdominal Fat	The Saggital Abdominal Height was used as estimate of visceral abdominal fat using a portable anthropometer.	Baseline and 10 Weeks
Change in Waist circumference	Waist circumference was used to measure central adiposity with a Gulick body tape measure.	Baseline and 10 Weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Body Composition; Physical Fitness; Executive Cognitive Function
• Other Study ID Numbers: 20120486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only the study investigators and/or sponsor will monitor the plan for data and safety monitoring for this study. Shared data will be done through encrypted files and file management platform OneDrive.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No