Pediatric ObesityTXCORDPRIMNCT04625998
Texas Childhood Obesity Research Demonstration (TX CORD) Project -Primary Prevention Study
A study testing Enhanced CATCH Elementary School Program and CATCH Early Childhood (CEC) in people with Pediatric Obesity, run by The University of Texas Health Science Center, Houston.
Trial summary
A systems approach emphasizes the linkage between individual behavior change strategies and social and physical environmental changes, which act synergistically to facilitate (or inhibit) healthy eating and active living. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Enhanced CATCH Elementary School Program and CATCH Early Childhood (CEC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,378 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Jan 2015
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children attending selected elementary schools or Head Start Centers in the catchment areas.
- Ages 2 to 12
Who cannot join
- Children who are special needs
About this study
Official title: Systems Approach to Obesity Prevention in Underserved Children in Texas - Primary Prevention
A systems approach emphasizes the linkage between individual behavior change strategies and social and physical environmental changes, which act synergistically to facilitate (or inhibit) healthy eating and active living. We hypothesize that among low income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce BMI compared to primary prevention alone.
- Conditions
- Pediatric Obesity
- Being tested
- Enhanced CATCH Elementary School Program, CATCH Early Childhood (CEC)
- Keywords
- Pediatric obesity, Diet, Physical activity, Schools, Early care and education
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CATCH Elementary School ProgramBehavioural
Also called CATCH; Coordinated School Health Program
Enhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide.
CATCH Early Childhood (CEC)Behavioural
Also called CEC, CATCH EC
Implementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Elementary schools and Head Start centers in the intervention catchment areas implemented (1) an enhanced Coordinated Approach To Child Health (CATCH) program for elementary schools using the CATCH Coordination Guide (Enhanced CATCH Elementary School Program), and (2) CATCH Early Childhood program for Head Start Centers. Receives: Behavioral: Enhanced CATCH Elementary School Program; Behavioral: CATCH Early Childhood (CEC) |
| Comparison | No intervention | Elementary schools and Head Start centers in the comparison catchment area used their regular school and early care and education (ECE) nutrition and physical activity programs. Elementary schools were required by law to implement a coordinated school health program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Population-level Child Obesity as Defined by BMI z-score
Change in Body Mass Index z-score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study startFeb 2012
- Primary completionJun 2014
- Study completionJan 2015
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 Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,378 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Baylor College of Medicine, Seton Healthcare Family, Texas Department of State Health Services, Duke University, City University of New York, School of Public Health
- Responsible party
- Principal investigator, Deanna Hoelscher, The University of Texas Health Science Center, Houston
- Investigators
- Deanna M Hoelscher, PhD, Principal investigator, The University of Texas Health Science Center, HoustonNancy F Butte, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625998
- Sponsor's protocol ID
- HSC-SPH-11-0513 (Primary)
- Acronym
- TXCORDPRIM
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hoelscher DM, Butte NF, Barlow S, Vandewater EA, Sharma SV, Huang T, Finkelstein E, Pont S, Sacher P, Byrd-Williams C, Oluyomi AO, Durand C, Li L, Kelder SH. Incorporating primary and secondary prevention approaches to address childhood obesity prevention and treatment in a low-income, ethnically diverse population: study design and demographic data from the Texas Childhood Obesity Research Demonstration (TX CORD) study. Child Obes. 2015 Feb;11(1):71-91. doi: 10.1089/chi.2014.0084. Epub 2015 Jan 2.
PubMed 25555188Oluyomi AO, Byars A, Byrd-Williams C, Sharma SV, Durand C, Hoelscher DM, Butte NF, Kelder SH. The utility of Geographical Information Systems (GIS) in systems-oriented obesity intervention projects: the selection of comparable study sites for a quasi-experimental intervention design--TX CORD. Child Obes. 2015 Feb;11(1):58-70. doi: 10.1089/chi.2014.0054. Epub 2015 Jan 14.
PubMed 25587670
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Approach to Obesity Prevention in Underserved Children in Texas - Primary Prevention
- ClinicalTrials.gov ID
- NCT04625998
- Acronym / sponsor ID
- TXCORDPRIM / HSC-SPH-11-0513 (Primary)
- Conditions
- Pediatric Obesity
- Keywords
- Pediatric obesity, Diet, Physical activity, Schools, Early care and education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,378 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Baylor College of Medicine, Seton Healthcare Family, Texas Department of State Health Services, Duke University, City University of New York, School of Public Health
- Study start
- Feb 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 12 Nov 2020 (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.
A systems approach emphasizes the linkage between individual behavior change strategies and social and physical environmental changes, which act synergistically to facilitate (or inhibit) healthy eating and active living. We hypothesize that among low income, ethnically diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity will reduce BMI compared to primary prevention alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Enhanced CATCH Elementary School Program, Behavioral: CATCH Early Childhood (CEC)Elementary schools and Head Start centers in the intervention catchment areas implemented (1) an enhanced Coordinated Approach To Child Health (CATCH) program for elementary schools using the CATCH Coordination Guide (Enhanced CATCH Elementary School Program), and (2) CATCH Early Childhood program for Head Start Centers. |
| Comparison | No intervention | –Elementary schools and Head Start centers in the comparison catchment area used their regular school and early care and education (ECE) nutrition and physical activity programs. Elementary schools were required by law to implement a coordinated school health program. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children attending selected elementary schools or Head Start Centers in the catchment areas.
- Ages 2 to 12
Key exclusion criteria (1 listed)
- Children who are special needs
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 |
|---|---|---|
| Enhanced CATCH Elementary School ProgramAlso: CATCH; Coordinated School Health ProgramEnhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide. | Behavioural | Intervention |
| CATCH Early Childhood (CEC)Also: CEC, CATCH ECImplementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers. | Behavioural | Intervention |
Primary outcome
Change in Population-level Child Obesity as Defined by BMI z-score
Time frame: 2 years
Change in Body Mass Index z-score
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 12 Nov 2020.
- Background: PubMed 25555188Hoelscher DM, Butte NF, Barlow S, Vandewater EA, Sharma SV, Huang T, Finkelstein E, Pont S, Sacher P, Byrd-Williams C, Oluyomi AO, Durand C, Li L, Kelder SH. Incorporating primary and secondary prevention approaches to address childhood obesity prevention and treatment in a low-income, ethnically diverse population: study design and demographic data from the Texas Childhood Obesity Research Demonstration (TX CORD) study. Child Obes. 2015 Feb;11(1):71-91. doi: 10.1089/chi.2014.0084. Epub 2015 Jan 2.
- Background: PubMed 25587670Oluyomi AO, Byars A, Byrd-Williams C, Sharma SV, Durand C, Hoelscher DM, Butte NF, Kelder SH. The utility of Geographical Information Systems (GIS) in systems-oriented obesity intervention projects: the selection of comparable study sites for a quasi-experimental intervention design--TX CORD. Child Obes. 2015 Feb;11(1):58-70. doi: 10.1089/chi.2014.0054. Epub 2015 Jan 14.
- 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.
Deanna M Hoelscher, PhD principal investigator
The University of Texas Health Science Center, Houston
Nancy F Butte, PhD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced CATCH Elementary School Program and CATCH Early Childhood (CEC) in people with Pediatric Obesity, run by The University of Texas Health Science Center, Houston.
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 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Population-level Child Obesity as Defined by BMI z-score (time frame: 2 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 NCT04625998, 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 12 Nov 2020.