- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02789215
Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs
January 13, 2020 updated by: Jayna Dave, Baylor College of Medicine
Child and Adult Care Food Program (CACFP) meals are an important influence on diets of children from low-income families enrolled in the CACFP and should meet children's nutrient needs while fostering healthy eating habits that enable them to maintain energy balance.
Recent national data revealed that children consumed low intakes of foods that support healthy dietary patterns (whole grains, fruit and vegetables other than potatoes), but high intakes of low nutrient, energy dense foods.
The 2011 USDA-commissioned Institute of Medicine (IOM) report for CACFP meals provided new recommendations that include new meal pattern requirements for the meals programs, aligning them with the U.S. Dietary Guidelines to ensure that the meals promote health and reduce inadequate and excessive intakes.
The report recommended inclusion of more whole grains, fruit, vegetables, and meat/meat alternatives which will likely increase meal costs.
Two of the IOM report recommendations call for research to better understand how the new meal requirements would change children's CACFP meal dietary intakes and food service costs.
These are important questions, and answers are needed to inform policy and future technical and educational assistance needs.
The overall objective of this project is to implement the IOM meal pattern requirements for CACFP meals in day homes and centers in Texas.
The multidisciplinary team will focus on nutrition, economics, and provider outcomes.
The specific aims are to assess the impact of the new meal pattern requirements on 1) Meal participation rates; 2) Provider food service costs (food, labor, total meals); and 3) Child dietary intake at CACFP homes and centers.
It is hypothesized that, compared with control sites, intervention site children will select and consume healthier diets (more fruit, vegetables and whole grains) at school.
A total of 32 day care sites will be recruited for the study.
It is hypothesized that, compared with control sites, children at the intervention sites will select and consume healthier diets (more fruit, vegetable and whole grains) at the center.
It is also hypothesized that the increase in food costs will be less than that projected in the IOM report.
The results on the costs associated with creating the desired meals will be very important as these data have not been systematically collected in previous studies.
This significant study targets underserved minority populations with health promoting intervention to reduce health disparities, and in addition, will inform policy on the influence of a healthy food environment on children's diet, as well as provide critical information on costs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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
- Baylor College of Medicine
-
-
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
3 years to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be day care sites
- Must be parents of children attending the day care sites
Exclusion:
- Parents of children not attending one of the 32 day care sites
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Receive new CACFP menu pattern
|
|
|
No Intervention: Control
Follow existing CACFP menu pattern
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline Child Dietary Intake at 6 months and 12 months
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Change from Baseline Meal Participation Rates at 6 months and 12 months
Time Frame: Up to 12 months
|
Up to 12 months
|
|
Change from Baseline Provider Food Service Costs (food, labor, total meals) at 6 months and 12 months
Time Frame: Up to 12 months
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Actual)
September 1, 2015
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
May 25, 2016
First Submitted That Met QC Criteria
June 1, 2016
First Posted (Estimate)
June 2, 2016
Study Record Updates
Last Update Posted (Actual)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- H-35784
- R01HL119520 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The Baylor College of Medicine understands and agrees to comply with the NIH policy on Sharing Research Data and on Sharing Model Organisms (as outlined in the NIH Guide, February 26, 2003 and May 7, 2004.)
The principal investigator and co-investigators acknowledge their willingness to share data and materials with other eligible investigators through academically established means.
Data will be shared with collaborators as soon as available, with local colleagues at seminars and talks, and with the scientific community at large by posters and presentations at local, regional, national and international scientific meetings.
Finally, data will be presented by publication to the widest audience possible.
Press interviews on important publications are arranged through the Baylor College of Medicine Office of Public Affairs.
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 Food Security
-
The University of Tennessee, KnoxvilleWithdrawn
-
Purdue UniversityUniversity of Kentucky Center for Poverty Research; North Central Nutrition...Completed
-
University of VermontRecruiting
-
NYU Langone HealthNational Institute on Aging (NIA)CompletedFood SecurityUnited States
-
International Food Policy Research InstituteWorld Food ProgramCompletedFood Security
-
North Carolina State UniversityEast Carolina UniversityRecruitingFruit and Vegetable Intake | Food Security | Nutrition Security | Diet InterventionsUnited States
-
South Dakota State UniversityUniversity of Missouri-Columbia; Ohio State University; Michigan State University and other collaboratorsCompletedFood Security | Nutritive Value
-
University of British ColumbiaCompleted
-
University of ChileBloomberg PhilanthropiesCompleted
-
University of Texas Southwestern Medical CenterCompletedDiet, Healthy | Food SecurityUnited States
Clinical Trials on Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs
-
Hospices Civils de LyonCompleted