Baby NAP SACC Intervention Study (BABY NAP SACC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01890681
First received: June 27, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. The focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. Outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. Child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.


Condition Intervention
Obesity
Behavioral: Baby NAP SACC
Behavioral: Back to Sleep

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Obesity in Infants and Toddlers in Child Care

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • change in weight-for-length z-score [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ] [ Designated as safety issue: No ]
  • change in skinfold thickness [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in child physical activity via accelerometer [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ] [ Designated as safety issue: No ]
  • change in child dietary intake [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ] [ Designated as safety issue: No ]
  • change in child care policies and practices [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ] [ Designated as safety issue: No ]

Estimated Enrollment: 960
Study Start Date: August 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Back to Sleep

The Back to Sleep arm will encourage safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS) in child care and at home. This include:

  1. center and family self-assessment,
  2. center intervention materials delivered several times over the 6-month period, and;
  3. parent handouts

After the intervention period, comparator centers will receive an abbreviated version of the Baby NAP SACC intervention.

Behavioral: Back to Sleep
Experimental: Baby NAP SACC

The intervention will include four complementary and mutually reinforcing components:

  1. center and family self-assessment;
  2. targeted technical assistance by Baby NAP SACC consultant for providers and parents;
  3. training workshops for child care providers; and
  4. parent outreach and support.
Behavioral: Baby NAP SACC

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • licensed child care centers in North Carolina (NC) serving children birth - 2
  • within 120 mile radius of Duke University
  • children must be from participating center and 3-14 months of age at baseline
  • read/speak English
  • adult teachers from infant/toddler classrooms within participating centers
  • adult parents of infant/toddlers within participating centers

Exclusion Criteria:

  • child care centers outside of 120 mile radius of Duke University
  • children over 14 months of age
  • parents with children who intend to leave the participating center in < 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01890681

Contacts
Contact: Sara Benjamin Neelon, PhD, MPH, RD 919-681-6990 sara.benjamin@dm.duke.edu

Locations
United States, North Carolina
University of North Carolina Chapel Hill Active, not recruiting
Chapel Hill, North Carolina, United States, 27516
Duke University Medical Center, Department of Community and Family Medicine Recruiting
Durham, North Carolina, United States, 27710
Contact: Jeff         
Sub-Investigator: Truls Ostbye, MD, PhD, MPH         
Sub-Investigator: Brian Neelon, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Sara Benjamin Neelon, PhD, RD, MPH Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01890681     History of Changes
Other Study ID Numbers: Pro00039195, R01DK093838
Study First Received: June 27, 2013
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Duke University:
childhood obesity
child care
infant
toddler

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014