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CompletedNCT01921842CCWSUpdated Aug 13, 2013

Child Care Wellness Study on Nutrition and Physical Activity

An interventional study of NAP-SACC Child Care Wellness Program in Overweight and Obesity, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-13.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
2 Years to 5 Years
Sex
All
01

Study summary

The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.

Read the 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.
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Conditions studied

  • Overweight
  • Obesity

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In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 18 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • If the randomly selected child care center has an open case of child abuse or neglect.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Nutrition and Physical Activity Training

    NAP-SACC Child Care Wellness program administered in year 1 of study

    Behavioral: NAP-SACC Child Care Wellness Program

  • Other
    Delayed Intervention Group

    NAP-SACC Child Care Wellness Program is administered in year 2 of study.

    Behavioral: NAP-SACC Child Care Wellness Program

Interventions

  • BehavioralNAP-SACC Child Care Wellness Program

    Nutrition And Physical activity Self-Assessment for Child Care

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What researchers measure

Primary outcomes

  1. Change in Nutrition and Physical Activity Policies

    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).

    Time frame: Baseline, Year 1, Year 2

Secondary outcomes

  1. Change in Nutrition and Physical Activity Behaviors

    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.

    Time frame: Baseline, Year 1, Year 2

Other outcomes

  1. Change in Body-Mass Index (BMI) of children in child care centers

    Determine if the use of a Nurse Child Care Health Consultant changes BMI of children at child care centers.

    Time frame: Baseline, Year 1, Year 2

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Study locations

1 site
  • Child Care Centers
    Wilmington, North Carolina 28401, United States
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References and documents

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. PubMed 24580983 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01921842
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
Yale University, University of California, San Francisco, HRSA/Maternal and Child Health Bureau
Responsible party
Sponsor
First posted
Aug 13, 2013
Start date
Jan 2008
Primary completion
May 2010
Completion
Aug 2010
Last update
Aug 13, 2013

Study contacts

Jonathan B Kotch, MD
principal investigator · University of North Carolina in Chapel Hill

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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