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Lace Up and Move: Structured After School Intervention for Hispanic and African American Youth (LUAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885115
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
United Health Foundation
Information provided by (Responsible Party):
Norma Olvera, University of Houston

Brief 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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Obesity Physical Activity Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Lace Up and Move: Structured After School Exercise Intervention for Hispanic and African American Youth
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: 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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Sleep [ Time Frame: pre & post intervention at Week 12 ]
    assess using self-report survey

  2. 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

  3. Body fat percentage [ Time Frame: pre & post intervention at Week 12 ]
    percent body fat obtained from a foot-to-foot bio-electrical impedance assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885115


Locations
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United States, Texas
University of Houston
Houston, Texas, United States, 77204
Sponsors and Collaborators
University of Houston
United Health Foundation
Investigators
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Principal Investigator: Norma Olvera University of Houston
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Responsible Party: Norma Olvera, Principal Investigator, University of Houston
ClinicalTrials.gov Identifier: NCT03885115    
Other Study ID Numbers: STUDY00000392
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms