NCT03182621

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable obesity

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 1, 2017

Last Update Submit

June 7, 2017

Conditions

Keywords

Physical FitnessBody CompositionExecutive Cognitive Function

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

THINK

EXPERIMENTAL

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

SPARK

ACTIVE COMPARATOR

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

Interventions

THINKBEHAVIORAL

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.

THINK
SPARKBEHAVIORAL

traditional YMCA program

SPARK

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arlette Perry, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2017

First Posted

June 9, 2017

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

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.