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Child Care Wellness Study on Nutrition and Physical Activity (CCWS)

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ClinicalTrials.gov Identifier: NCT01921842
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : August 13, 2013
Sponsor:
Collaborators:
Yale University
University of California, San Francisco
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 7, 2013
First Posted Date  ICMJE August 13, 2013
Last Update Posted Date August 13, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 9, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Child Care Wellness Study on Nutrition and Physical Activity
Official Title  ICMJE Promoting Nutrition and Physical Activity in Child Care Centers
Brief Summary The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.
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:

  1. 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,
  2. 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.,
  3. 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
  4. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE Behavioral: NAP-SACC Child Care Wellness Program
Nutrition And Physical activity Self-Assessment for Child Care
Study Arms  ICMJE
  • Experimental: Nutrition and Physical Activity Training
    NAP-SACC Child Care Wellness program administered in year 1 of study
    Intervention: Behavioral: NAP-SACC Child Care Wellness Program
  • Delayed Intervention Group
    NAP-SACC Child Care Wellness Program is administered in year 2 of study.
    Intervention: Behavioral: NAP-SACC Child Care Wellness Program
Publications * Alkon A, Crowley AA, Neelon SE, Hill S, Pan Y, Nguyen V, Rose R, Savage E, Forestieri N, Shipman L, Kotch JB. Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index. BMC Public Health. 2014 Mar 1;14:215. doi: 10.1186/1471-2458-14-215.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2013)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01921842
Other Study ID Numbers  ICMJE 07-1861
R40MC08727 ( Other Grant/Funding Number: Maternal and Child Health Bureau )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Yale University
  • University of California, San Francisco
  • HRSA/Maternal and Child Health Bureau
Investigators  ICMJE
Principal Investigator: Jonathan B Kotch, MD University of North Carolina in Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP