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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02789215
Other study ID # H-35784
Secondary ID R01HL119520
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date May 31, 2019

Study information

Verified date January 2020
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date May 31, 2019
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs


Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor College of Medicine National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dave JM, Cullen KW. Foods Served in Child Care Facilities Participating in the Child and Adult Care Food Program: Menu Match and Agreement with the New Meal Patterns and Best Practices. J Nutr Educ Behav. 2018 Jun;50(6):582-588. doi: 10.1016/j.jneb.2018.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Child Dietary Intake at 6 months and 12 months Up to 12 months
Primary Change from Baseline Meal Participation Rates at 6 months and 12 months Up to 12 months
Primary Change from Baseline Provider Food Service Costs (food, labor, total meals) at 6 months and 12 months Up to 12 months
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