- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01921842
Child Care Wellness Study on Nutrition and Physical Activity (CCWS)
August 9, 2013 updated by: University of North Carolina, Chapel Hill
Promoting Nutrition and Physical Activity in Child Care Centers
The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The broad, long term goal is to develop a reproducible nutrition and physical activity intervention which utilizes child care consultant nutrition specialists to reduce the risk of overweight among children in regulated out-of-home child care. The objectives are:
- To train Child Care Health consultants (CCHCs) to become specialists in nutrition consultation in child care such that they will increase their daily consultation activities on nutrition, physical activity, and childhood overweight,
- To increase child care staff and parental knowledge of and positive attitudes toward providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers.,
- To strengthen child care center policies, procedures, practices and behaviors, regarding providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers, and
- To improve dietary intake and levels of physical activity, and to prevent increases in overweight and the risk of overweight as determined by body mass indexes among children in out-of-home child care centers.
Study Type
Interventional
Enrollment (Actual)
18
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
-
-
North Carolina
-
Wilmington, North Carolina, United States, 28401
- Child Care Centers
-
-
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
2 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy.
Exclusion Criteria:
- If the randomly selected child care center has an open case of child abuse or neglect.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutrition and Physical Activity Training
NAP-SACC Child Care Wellness program administered in year 1 of study
|
Nutrition And Physical activity Self-Assessment for Child Care
|
|
Other: Delayed Intervention Group
NAP-SACC Child Care Wellness Program is administered in year 2 of study.
|
Nutrition And Physical activity Self-Assessment for Child Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Nutrition and Physical Activity Policies
Time Frame: Baseline, Year 1, Year 2
|
Determine if the use of a Nurse Child Care Health Consultant changes nutrition and physical activity policies at child care centers using criteria based on the national standards identified from resources such as NAEYC accreditation guidelines, Child and Adult Care Food Program (CACFP) policies and requirements, and the joint APHA/AAP publication Caring for our Children (American Academy of Pediatrics, American Public Health Association & National Resource Center for Health and Safety in Child Care, 2002; 1992).
If written policies were present, they were compared to the gold-standard criteria from the national resource material and assigned a rating of either none (no written policies), poor (written policies fail to meet either state regulatory criteria or national standards), adequate (meets state regulatory criteria but not all of the national standards), or excellent (meets all of the national criteria present).
|
Baseline, Year 1, Year 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Nutrition and Physical Activity Behaviors
Time Frame: Baseline, Year 1, Year 2
|
Determine if the use of a Nurse Child Care Health Consultant changes nutrition and physical activity behaviors at child care centers using the NAP SACC instrument intervention tool which consists of fifteen different areas of interest (9 nutrition and 6 physical activity) with several items each.
The total number of items scored, 34, evaluate the center's environment with regard to support of healthy eating and regular physical activity.
The instrument scoring is at one of four levels moving from minimal to best practice.
|
Baseline, Year 1, Year 2
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body-Mass Index (BMI) of children in child care centers
Time Frame: Baseline, Year 1, Year 2
|
Determine if the use of a Nurse Child Care Health Consultant changes BMI of children at child care centers.
|
Baseline, Year 1, Year 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jonathan B Kotch, MD, University of North Carolina in Chapel Hill
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.
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
January 1, 2008
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
August 7, 2013
First Submitted That Met QC Criteria
August 9, 2013
First Posted (Estimate)
August 13, 2013
Study Record Updates
Last Update Posted (Estimate)
August 13, 2013
Last Update Submitted That Met QC Criteria
August 9, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-1861
- R40MC08727 (Other Grant/Funding Number: Maternal and Child Health Bureau)
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.
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