- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885115
Lace Up and Move: Structured After School Intervention for Hispanic and African American Youth (LUAM)
April 3, 2019 updated by: Norma Olvera, University of Houston
Lace Up and Move: Structured After School Exercise Intervention for Hispanic and African American Youth
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77204
- University of Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants randomly assigned to the experiential group (EG) will receive a 12-week structured exercise that will consist of two group fitness sessions (i.e.
kickboxing, Zumba, fitness yoga, and other aerobic exercises) every week.
Certified fitness instructors will lead each session and participants will learn strategies how to be more active during the daily routines at home.
Parents or other relatives in the EG will participate in one 2-hour session every four weeks (total of 3 sessions) designed to help them support their children and entire family in being active and eat healthy at home.
Parents will meet with a fitness instructor who will provide specific tips on how to increase physical activity at home as well as providing community resources to be active.
A basic nutrition education and cooking demonstrations, and healthy recipes will be also provided to parents at these workshops.
Data/assessments are collected, pre and post the 12 weeks intervention.
|
Involves 12-weeks of education related to healthy behaviors, nutrition, and exercise from certified fitness instructors.
|
|
No Intervention: Control
Participants randomly assigned to the control group (CG) will receive once a week recreational structured group play/game sessions led by trained BOUNCE interns/staff.
The control group will receive 60 minute of structured free play sessions (i.e.
recreational games) once a week for 12 weeks.
Every 4 weeks, parents will be given (either sent home with their child or via email or mail) basic nutrition information, healthy recipes, and tips to promote physical activity at home as well as community resources to be active.
Data/assessments are collected, pre and post the 12 weeks intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Physical Activity
Time Frame: pre & post intervention at Week 12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep
Time Frame: pre & post intervention at Week 12
|
assess using self-report survey
|
pre & post intervention at Week 12
|
|
Sleep Quality
Time Frame: pre & post intervention at Week 12
|
assess quality of sleep patterns using a small motion analyzer that measures sleep efficiency, duration and latency
|
pre & post intervention at Week 12
|
|
Body fat percentage
Time Frame: pre & post intervention at Week 12
|
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
|
pre & post intervention at Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Norma Olvera, University of Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2017
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
March 19, 2019
First Submitted That Met QC Criteria
March 19, 2019
First Posted (Actual)
March 21, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000392
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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