- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726529
Brighter Bites - Access, Continuity and Education With Fruits and Vegetables (Brighter Bites)
March 31, 2016 updated by: Shreela V Sharma, The University of Texas Health Science Center, Houston
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
710
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 7 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Child is in enrolled in the 1st grade in the participating school
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brighter Bites
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.
|
The comparison schools received training in implementing the Coordinated Approach to Child Health (CATCH) school-based health promotion program
|
Active Comparator: Comparison
|
The comparison schools received training in implementing the Coordinated Approach to Child Health (CATCH) school-based health promotion program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
baseline to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shreela Sharma, PhD, RD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
March 24, 2016
First Submitted That Met QC Criteria
March 31, 2016
First Posted (Estimate)
April 1, 2016
Study Record Updates
Last Update Posted (Estimate)
April 1, 2016
Last Update Submitted That Met QC Criteria
March 31, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SPH-12-0480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Childhood Obesity
-
Universiteit LeidenWageningen University; Nutricia, Inc.; Danone ResearchCompletedChildhood Obesity | Childhood Overweight | Vegetable Acceptance in Early ChildhoodNetherlands
-
Vanderbilt University Medical CenterActive, not recruitingPediatric Obesity | Childhood Obesity | Childhood Onset ObesityUnited States
-
Tehran University of Medical SciencesUnknownChildhood Obesity PreventionIran, Islamic Republic of
-
Oregon State UniversityCompletedChildhood Obesity Prevention
-
The Miriam HospitalHassenfeld Child Health Innovation InstituteCompletedChildhood Obesity PreventionUnited States
-
Fundacion para la Formacion e Investigacion Sanitarias...UnknownChildhood Obesity PreventionSpain
-
Tampere UniversitySeinajoki Central Hospital; Tampere University Hospital; Foundation for Paediatric... and other collaboratorsCompleted
-
Cornell UniversityCompletedChildhood Obesity Prevention
-
Harokopio UniversityCompletedPrevention of Childhood ObesityGreece
-
University of Alabama at BirminghamCompletedObesity, Childhood | Overweight, ChildhoodUnited States
Clinical Trials on Brighter Bites
-
The University of Texas Health Science Center,...Vitamix Foundation; University of Texas at Austin; Brighter Bites; Penn State Better...Not yet recruitingObesity | Mental Health Wellness 1 | Nutrition, Healthy | Diabetes Mellitus RiskUnited States
-
The University of Texas Health Science Center,...Brighter BitesRecruiting
-
The University of Texas Health Science Center,...Bank of America FoundationRecruitingWeight LossUnited States
-
The University of Texas Health Science Center,...TerminatedWound ComplicationUnited States
-
Erasmus Medical CenterElisabeth-TweeSteden Ziekenhuis; Rijnstate Hospital; Red Cross Hospital Beverwijk and other collaboratorsRecruitingQuality of Life | Pain | Surgery | Wound Infection | Incisional Hernia | Fascial DehiscenceNetherlands
-
University of OxfordMahidol UniversityRecruiting
-
University of OxfordNational Health and Medical Research Council, Australia; Burnet Institute; Agency...Recruiting
-
Imam Abdulrahman Bin Faisal UniversityNot yet recruitingIncisional Hernia | Suture, Complication | Incision, Surgical
-
Socrates Herrera ValenciaCompleted
-
Odense University HospitalUnknownLyme NeuroborreliosisDenmark