Childhood ObesityLUAMNCT03885115
Lace Up and Move: Structured After School Intervention for Hispanic and African American Youth
A study testing Intervention in people with Childhood Obesity and Obesity, run by University of Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Obesity, Physical Activity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity, Obesity, Physical Activity
- Being tested
- Intervention
- Medical subject headings
- Pediatric Obesity, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Involves 12-weeks of education related to healthy behaviors, nutrition, and exercise from certified fitness instructors.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Physical Activity
measure the percentage of youth who meet 60 minutes of daily moderate-to-vigorous physical activity per week
Measured: pre & post intervention at Week 12
Secondary outcomes (3)
Sleep
assess using self-report survey
Measured: pre & post intervention at Week 12
Sleep Quality
assess quality of sleep patterns using a small motion analyzer that measures sleep efficiency, duration and latency
Measured: pre & post intervention at Week 12
Body fat percentage
percent body fat obtained from a foot-to-foot bio-electrical impedance assessment
Measured: pre & post intervention at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start28 Nov 2017
- Primary completionDec 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- United Health Foundation
- Responsible party
- Principal investigator, Norma Olvera, University of Houston
- Investigators
- Norma Olvera, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885115
- Sponsor's protocol ID
- STUDY00000392
- Acronym
- LUAM
- Status last verified
- Apr 2019
- First submitted
- 19 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lace Up and Move: Structured After School Exercise Intervention for Hispanic and African American Youth
- ClinicalTrials.gov ID
- NCT03885115
- Acronym / sponsor ID
- LUAM / STUDY00000392
- Conditions
- Childhood Obesity, Obesity, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- United Health Foundation
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionInvolves 12-weeks of education related to healthy behaviors, nutrition, and exercise from certified fitness instructors. | Behavioural | Intervention |
Primary outcome
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
3 secondary outcomes
Sleep
Time frame: pre & post intervention at Week 12
Sleep Quality
Time frame: pre & post intervention at Week 12
Body fat percentage
Time frame: pre & post intervention at Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norma Olvera principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Childhood Obesity and Obesity, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Physical Activity (time frame: pre & post intervention at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.