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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03182621
Other study ID # 20120486
Secondary ID
Status Completed
Phase N/A
First received June 1, 2017
Last updated June 7, 2017
Start date January 2014
Est. completion date August 2014

Study information

Verified date June 2017
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
SPARK
traditional YMCA program

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Miami University of Tennessee

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in Grip Strength Grip strength was measures using a Jamar plus handgrip dynamometer. Baseline and 10 Weeks
Primary Change in Abdominal Strength The one-minute curl-up test was used to measure abdominal strength and endurance. Baseline and 10 Weeks
Primary 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) = v4.9 x mass (kg) x vVJ (m) x 9.81. Baseline and 10 Weeks
Primary Change in Percent Body Fat Body composition and body fat was measured using the Inbody-520 multi-frequency bioimpedance analyzer. Baseline and 10 Weeks
Primary Change in BMIz A CDC growth chart statistical resource was used to calculate BMIz using height, weight, age, and gender. Baseline and 10 Weeks
Primary 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
Primary Change in Waist circumference Waist circumference was used to measure central adiposity with a Gulick body tape measure. Baseline and 10 Weeks
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