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

Primary Purpose

Childhood Obesity, Obesity, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child Physical Activity
measure the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week

Secondary Outcome Measures

Sleep
assess using self-report survey
Sleep Quality
assess quality of sleep patterns using a small motion analyzer that measures sleep efficiency, duration and latency
Body fat percentage
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment

Full Information

First Posted
March 19, 2019
Last Updated
April 3, 2019
Sponsor
University of Houston
Collaborators
United Health Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03885115
Brief Title
Lace Up and Move: Structured After School Intervention for Hispanic and African American Youth
Acronym
LUAM
Official Title
Lace Up and Move: Structured After School Exercise Intervention for Hispanic and African American Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
United Health Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Obesity, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Involves 12-weeks of education related to healthy behaviors, nutrition, and exercise from certified fitness instructors.
Primary Outcome Measure Information:
Title
Child Physical Activity
Description
measure the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week
Time Frame
pre & post intervention at Week 12
Secondary Outcome Measure Information:
Title
Sleep
Description
assess using self-report survey
Time Frame
pre & post intervention at Week 12
Title
Sleep Quality
Description
assess quality of sleep patterns using a small motion analyzer that measures sleep efficiency, duration and latency
Time Frame
pre & post intervention at Week 12
Title
Body fat percentage
Description
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
Time Frame
pre & post intervention at Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma Olvera
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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