NCT01921842

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration 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

January 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

2.3 years

First QC Date

August 7, 2013

Last Update Submit

August 9, 2013

Conditions

Outcome Measures

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).

    Baseline, Year 1, Year 2

Secondary Outcomes (1)

  • Change in Nutrition and Physical Activity Behaviors

    Baseline, Year 1, Year 2

Other Outcomes (1)

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

    Baseline, Year 1, Year 2

Study Arms (2)

Nutrition and Physical Activity Training

EXPERIMENTAL

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

Behavioral: NAP-SACC Child Care Wellness Program

Delayed Intervention Group

OTHER

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

Behavioral: NAP-SACC Child Care Wellness Program

Interventions

Nutrition And Physical activity Self-Assessment for Child Care

Delayed Intervention GroupNutrition and Physical Activity Training

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Care Centers

Wilmington, North Carolina, 28401, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan B Kotch, MD

    University of North Carolina in Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 13, 2013

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

August 1, 2010

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations