NCT02789215

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

May 25, 2016

Last Update Submit

January 13, 2020

Conditions

Keywords

Child care food costsMeal participation ratesChild and Adult Care Food Program

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline Child Dietary Intake at 6 months and 12 months

    Up to 12 months

  • Change from Baseline Meal Participation Rates at 6 months and 12 months

    Up to 12 months

  • Change from Baseline Provider Food Service Costs (food, labor, total meals) at 6 months and 12 months

    Up to 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Receive new CACFP menu pattern

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

Control

NO INTERVENTION

Follow existing CACFP menu pattern

Interventions

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be day care sites
  • Must be parents of children attending the day care sites

You may not qualify if:

  • Parents of children not attending one of the 32 day care sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related 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.2018.01.010. Epub 2018 Feb 21.

Related Links

MeSH Terms

Interventions

Costs and Cost Analysis

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 2, 2016

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 31, 2019

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

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.

Locations