Childhood ObesityBrighter BitesNCT02726529
Brighter Bites - Access, Continuity and Education With Fruits and Vegetables
A study testing Brighter Bites and CATCH in people with Childhood Obesity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the research is to find out how well a new nutrition program works for elementary school students and their families. This program is called Brighter Bites. Brighter Bites is a school-based program that teaches students and their parents about the importance of eating fresh fruits and vegetables and how… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Brighter Bites and CATCH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is in enrolled in the 1st grade in the participating school
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of the research is to find out how well a new nutrition program works for elementary school students and their families. This program is called Brighter Bites. Brighter Bites is a school-based program that teaches students and their parents about the importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy ways. This project is being carried out at six elementary schools in Houston, Texas. Up to 600 first grade students and their parents/guardians are expected to join this project.
- Conditions
- Childhood Obesity
- Being tested
- Brighter Bites, CATCH
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brighter BitesBehavioural
CATCHBehavioural
The comparison schools received training in implementing the Coordinated Approach to Child Health (CATCH) school-based health promotion program
| Study group | Role | What they receive |
|---|---|---|
| Brighter Bites | Experimental | Children of families in the intervention group will also receive the Coordinated Approach to Child Health (CATCH) school-based curriculum in addition to families receiving fresh fruits and vegetables to take home from school once a week along with nutrition education for 8 weeks in Fall and 8 weeks in Spring semesters of the school year. Receives: Behavioral: Brighter Bites; Behavioral: CATCH |
| Comparison | Active comparator | Not described Receives: Behavioral: CATCH |
What is being measured
The primary outcome is the main question the study is designed to answer.
change intake of servings of fruits and vegetables for the child as assessed using the parent-reported food frequency questionnaire
Child dietary intake was measured using the parent-reported Block Kids Food validated screener to assess children's intake by food group, with outcomes measured in number of servings. The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets). A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Individual portion sizes are asked. This screener takes about 10-12 minutes to complete. Servings of fruits and vegetables consumed are cumulatively reported.
Measured: baseline to 16 weeks
Secondary outcomes (4)
change in intake of grams of sugar for the child as assessed using the parent-reported food frequency questionnaire
Child dietary intake was measured using the parent-reported Block Kids Food validated screener to assess children's intake by food group, with outcomes measured in number of servings. The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets). A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Individual portion sizes are asked. This screener takes about 10-12 minutes to complete.
Measured: baseline to 16 weeks
change in intake of grams of fat for the child as assessed using the parent-reported food frequency questionnaire
Child dietary intake was measured using the parent-reported Block Kids Food validated screener to assess children's intake by food group, with outcomes measured in number of servings. The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets). A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Individual portion sizes are asked. This screener takes about 10-12 minutes to complete.
Measured: baseline to 16 weeks
change in intake of servings of fruits and vegetables for the parent as assessed using the parent-reported food frequency questionnaire
The validated 10-item Fruits and Vegetables Screener by the National Institutes of Health was administered to parents to determine the total number of servings of fruits and vegetables consumed daily.
Measured: baseline to 16 weeks
change in availability of fruits and vegetables in the home as assessed using parent-reported surveys
Parents completed a self-report survey measuring frequency of availability of fresh fruits and vegetables at meals and snacks at home during the past 7 days.
Measured: baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startAug 2013
- Primary completionJun 2015
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.
- 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
- 710 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shreela V Sharma, The University of Texas Health Science Center, Houston
- Investigators
- Shreela Sharma, PhD, RD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726529
- Sponsor's protocol ID
- HSC-SPH-12-0480
- Acronym
- Brighter Bites
- Status last verified
- Mar 2016
- First submitted
- 24 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brighter Bites - Access, Continuity and Education With Fruits and Vegetables
- ClinicalTrials.gov ID
- NCT02726529
- Acronym / sponsor ID
- Brighter Bites / HSC-SPH-12-0480
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 710 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jun 2015 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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 the research is to find out how well a new nutrition program works for elementary school students and their families. This program is called Brighter Bites. Brighter Bites is a school-based program that teaches students and their parents about the importance of eating fresh fruits and vegetables and how to prepare them in tasty, healthy ways. This project is being carried out at six elementary schools in Houston, Texas. Up to 600 first grade students and their parents/guardians are expected to join this project.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brighter Bites | Experimental | Behavioral: Brighter Bites, Behavioral: CATCHChildren of families in the intervention group will also receive the Coordinated Approach to Child Health (CATCH) school-based curriculum in addition to families receiving fresh fruits and vegetables to take home from school once a week along with nutrition education for 8 weeks in Fall and 8 weeks in Spring semesters of the school year. |
| Comparison | Active comparator | Behavioral: CATCH |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child is in enrolled in the 1st grade in the participating school
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Brighter Bites | Behavioural | Brighter Bites |
| CATCHThe comparison schools received training in implementing the Coordinated Approach to Child Health (CATCH) school-based health promotion program | Behavioural | Brighter Bites, Comparison |
Primary outcome
change intake of servings of fruits and vegetables for the child as assessed using the parent-reported food frequency questionnaire
Time frame: baseline to 16 weeks
Child dietary intake was measured using the parent-reported Block Kids Food validated screener to assess children's intake by food group, with outcomes measured in number of servings. The focus of this tool is on intake of fruit and fruit juices, vegetables, potatoes (including French fries), whole grains, meat/poultry/fish, dairy, legumes, saturated fat, "added sugars" (in sweetened cereals, soft drinks, and sweets). A secondary analysis produces estimates for intake of sugary beverages (both kcal and frequency). Individual portion sizes are asked. This screener takes about 10-12 minutes to complete. Servings of fruits and vegetables consumed are cumulatively reported.
4 secondary outcomes
change in intake of grams of sugar for the child as assessed using the parent-reported food frequency questionnaire
Time frame: baseline to 16 weeks
change in intake of grams of fat for the child as assessed using the parent-reported food frequency questionnaire
Time frame: baseline to 16 weeks
change in intake of servings of fruits and vegetables for the parent as assessed using the parent-reported food frequency questionnaire
Time frame: baseline to 16 weeks
change in availability of fruits and vegetables in the home as assessed using parent-reported surveys
Time frame: baseline to 16 weeks
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 1 Apr 2016.
- 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.
Shreela Sharma, PhD, RD principal investigator
The University of Texas Health Science Center, 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 Brighter Bites and CATCH in people with Childhood Obesity, run by The University of Texas Health Science Center, 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 1 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 1 Apr 2016. 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?
change intake of servings of fruits and vegetables for the child as assessed using the parent-reported food frequency questionnaire (time frame: baseline to 16 weeks). 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 1 Apr 2016.