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

• ClinicalTrials.gov Identifier: NCT03885115
• Recruitment Status: Active, not recruiting
• First Posted: March 21, 2019
• Last Update Posted: April 8, 2019
• Sponsor: University of Houston
• Collaborator: United Health Foundation
• Information provided by (Responsible Party): Norma Olvera, University of Houston

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Texas

University of Houston

Houston, Texas, United States, 77204

Sponsors and Collaborators

University of Houston

United Health Foundation

Investigators

• Principal Investigator: Norma Olvera; University of Houston

More Information

• Responsible Party: Norma Olvera, Principal Investigator, University of Houston
• ClinicalTrials.gov Identifier: NCT03885115
• Other Study ID Numbers: STUDY00000392
• First Posted: March 21, 2019
• Last Update Posted: April 8, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight