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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03885115
Other study ID # STUDY00000392
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 28, 2017
Est. completion date May 2020

Study information

Verified date April 2019
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy of Lace Up and Move (LUAM), a structured after-school exercise intervention, designed to increase moderate-to-vigorous physical activity (MVPA) and enhance sleep quality among Hispanic and African American (AA) boys and girls.


Description:

This study uses a randomized comparison-group pre-post-test design. Overall objectives of LUAM are to: (1) to increase the percentage of youth who meet 60 minutes of daily MVPA per week; (2) to improve the quality of sleep patterns (i.e., sleep efficiency and duration); and (3) to reduce percent body fat (%BF). It is hypothesized that compared to the control group (CG) participants, the experimental group (EG) participants will exhibit: (a) greater increase in percentage of children who meet 60 minutes of daily MVPA per week; (b) greater increase of sleep efficiency and duration; and (c) greater decrease in sleep latency and (d) greater decrease in %BF.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 600
Est. completion date May 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility Inclusion Criteria:

- child and at least their mother [or one member of the family] must be of Hispanic or African American descent

- child must have no physical disability or medical conditions that interfere with their participation in the exercise program

Exclusion Criteria:

- neither child nor parental guardians is of Hispanic or African American descent

- child is not between the ages of 9-14 years

- child is pregnant or physically unable to participate in the exercise program.

Study Design


Intervention

Behavioral:
Intervention
Involves 12-weeks of education related to healthy behaviors, nutrition, and exercise from certified fitness instructors.

Locations

Country Name City State
United States University of Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Houston United Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Physical Activity measure the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week pre & post intervention at Week 12
Secondary Sleep assess using self-report survey pre & post intervention at Week 12
Secondary Sleep Quality assess quality of sleep patterns using a small motion analyzer that measures sleep efficiency, duration and latency pre & post intervention at Week 12
Secondary Body fat percentage percent body fat obtained from a foot-to-foot bio-electrical impedance assessment pre & post intervention at Week 12
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