Childhood ObesitySTEPSPreKNCT05501392
South Texas Early Prevention Studies PreK
A study testing STEPS-PreK in people with Childhood Obesity, run by University of Texas Rio Grande Valley at 1 site in United States.
Trial summary
The South Texas Early Prevention Study-Prekindergarten (STEPS-PreK4) was a cluster randomized trial (CRT) of preschool children 4 years of age to test the effect of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on childhood obesity prevalence prevention. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- STEPS-PreK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,277 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2018to 30 Jun 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- PreK children
- Enrolled in PSJA and La Joya ISDs
Who cannot join
- na
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Rio Grande Valley
Edinburg, Texas, 78539
About this study
Official title: South Texas Early Prevention Studies - PreK
The South Texas Early Prevention Study-Prekindergarten (STEPS-PreK4) was a cluster randomized trial (CRT) of preschool children 4 years of age to test the effect of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on childhood obesity prevalence prevention.
Read the detailed description
The STEPS-PreK4 was a CRT where preschools, embedded within elementary schools, were the unit of randomization, intervention, and analysis. The study was designed for two years of intervention (pre-kinder to kindergarten) and four data collection periods (fall 2018, spring 2019, fall 2019, and spring 2020). Due to the COVID-19 pandemic the study was stopped prematurely and only results from the first three periods will be presented.
The two school districts where the study was conducted are located along the Texas-Mexico border in the county of Hidalgo. These school districts were selected because of the high poverty and health risk-factors levels.25 The preschools have two grade levels with children 3 and 4 years of age. The present study targeted preschools with children 4 years of age. Demographics of the two school districts were similar, 99% Hispanic, 92% economically disadvantaged, and 42% identified as English as a second language.
- Conditions
- Childhood Obesity
- Being tested
- STEPS-PreK
- Keywords
- Prek children, obesity prevalence
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPS-PreKBehavioural
Intervention group received the BN CHSP, a Texas Education Agency (TEA)-approved CSHP. This health program was first piloted in schools located in low-income neighborhoods where enrollment was predominantly Black and Latino children. The Social-Ecological Model guided the BN CSHP design. This theory postulates that health behaviors are molded by individual, interpersonal, and environmental interactions. Thus, BN CSHP encompasses curricula from preschool to eighth grade and is designed to target the four environments that influence children's health behaviors: 1) Healthy Lifestyles Healthy Minds (Health), 2) Moving For Life (Physical Education), 3) Eat to Live (Child Nutrition/School Food Service), and 4) MyFamily/MiFamilia (Home).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group received health education, P.E. classes, child nutritional services, as well as a parent component. Receives: Behavioral: STEPS-PreK |
| Control | Active comparator | This group received their usual health education and P.E. classes. Receives: Behavioral: STEPS-PreK |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiorespiratory fitness
as measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start28 Sep 2018
- Primary completion17 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Sequential
- Model description
- There were three sequential data collection periods through the process.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Rio Grande Valley
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Elizabeth Alanis, Masters, Study director, University of Texas Rio Grande Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501392
- Sponsor's protocol ID
- STEPS
- Acronym
- STEPSPreK
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data will be shared
Publications
Trevino-Pena R, Wang X, Wang L, Romero Z, Alanis E, Li H. Social and Health Risk Factor Levels of Preschool Children Living Along the Texas-Mexico Border. J Sch Health. 2020 Dec 2. doi: 10.1111/josh.12979. Online ahead of print.
PubMed 33289119Trevino-Pena R, Romero Z, Fuentes JC, Cortez KE, Alanis E, Alvarenga JCL. A Coordinated School Health Program Effect on Cardiorespiratory Fitness of South Texas Preschool Children: A Cluster Randomized Trial. J Sch Health. 2024 Apr;94(4):336-345. doi: 10.1111/josh.13414. Epub 2024 Jan 22.
PubMed 38252805
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Texas Early Prevention Studies - PreK
- ClinicalTrials.gov ID
- NCT05501392
- Acronym / sponsor ID
- STEPSPreK / STEPS
- Conditions
- Childhood Obesity
- Keywords
- Prek children, obesity prevalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,277 participants (actual)
- Lead sponsor
- University of Texas Rio Grande ValleyUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 Aug 2022 (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 South Texas Early Prevention Study-Prekindergarten (STEPS-PreK4) was a cluster randomized trial (CRT) of preschool children 4 years of age to test the effect of the Bienestar/NEEMA Coordinated School Health Program (BN CSHP) on childhood obesity prevalence prevention.
Detailed description
The STEPS-PreK4 was a CRT where preschools, embedded within elementary schools, were the unit of randomization, intervention, and analysis. The study was designed for two years of intervention (pre-kinder to kindergarten) and four data collection periods (fall 2018, spring 2019, fall 2019, and spring 2020). Due to the COVID-19 pandemic the study was stopped prematurely and only results from the first three periods will be presented.
The two school districts where the study was conducted are located along the Texas-Mexico border in the county of Hidalgo. These school districts were selected because of the high poverty and health risk-factors levels.25 The preschools have two grade levels with children 3 and 4 years of age. The present study targeted preschools with children 4 years of age. Demographics of the two school districts were similar, 99% Hispanic, 92% economically disadvantaged, and 42% identified as English as a second language.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There were three sequential data collection periods through the process.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: STEPS-PreKThis group received health education, P.E. classes, child nutritional services, as well as a parent component. |
| Control | Active comparator | Behavioral: STEPS-PreKThis group received their usual health education and P.E. classes. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- PreK children
- Enrolled in PSJA and La Joya ISDs
Key exclusion criteria (1 listed)
- na
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 |
|---|---|---|
| STEPS-PreKIntervention group received the BN CHSP, a Texas Education Agency (TEA)-approved CSHP. This health program was first piloted in schools located in low-income neighborhoods where enrollment was predominantly Black and Latino children. The Social-Ecological Model guided the BN CSHP design. This theory postulates that health behaviors are molded by individual, interpersonal, and environmental interactions. Thus, BN CSHP encompasses curricula from preschool to eighth grade and is designed to target the four environments that influence children's health behaviors: 1) Healthy Lifestyles Healthy Minds (Health), 2) Moving For Life (Physical Education), 3) Eat to Live (Child Nutrition/School Food Service), and 4) MyFamily/MiFamilia (Home). | Behavioural | Control, Intervention |
Primary outcome
cardiorespiratory fitness
Time frame: 1.5 years
as measured by the number of laps run in the Progressive Anaerobic Capacity Endurance Run (PACER) fitness test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 33289119Trevino-Pena R, Wang X, Wang L, Romero Z, Alanis E, Li H. Social and Health Risk Factor Levels of Preschool Children Living Along the Texas-Mexico Border. J Sch Health. 2020 Dec 2. doi: 10.1111/josh.12979. Online ahead of print.
- Derived from this study: PubMed 38252805Trevino-Pena R, Romero Z, Fuentes JC, Cortez KE, Alanis E, Alvarenga JCL. A Coordinated School Health Program Effect on Cardiorespiratory Fitness of South Texas Preschool Children: A Cluster Randomized Trial. J Sch Health. 2024 Apr;94(4):336-345. doi: 10.1111/josh.13414. Epub 2024 Jan 22.
- Website for STEPS PreK project protocol especially parental outreach newsletters and consent forms (English and Spanish).Link provided by the sponsor.
- Individual participant dataSharing planned: No. Only aggregated data will be shared
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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.
Elizabeth Alanis, Masters study director
University of Texas Rio Grande Valley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPS-PreK in people with Childhood Obesity, run by University of Texas Rio Grande Valley 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 1 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: finished, as of the sponsor's last update on 16 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cardiorespiratory fitness (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501392, which also lists 2 linked publications.
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 16 Aug 2022.