NCT03885115

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

March 19, 2019

Last Update Submit

April 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Sleep

    pre & post intervention at Week 12

  • Sleep Quality

    pre & post intervention at Week 12

  • Body fat percentage

    pre & post intervention at Week 12

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO 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.

Interventions

InterventionBEHAVIORAL

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

Intervention

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Pediatric ObesityObesityMotor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Norma Olvera

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

November 28, 2017

Primary Completion

December 1, 2019

Study Completion

May 1, 2020

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations