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Baby Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) Intervention Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01890681
First Posted: July 2, 2013
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Johns Hopkins 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) ]
  • change in skinfold thickness [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]

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) ]
  • change in child dietary intake [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]
  • change in child care policies and practices [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]

Estimated Enrollment: 960
Actual Study Start Date: August 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 3-18 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 younger than 3 months or over 18 months of age
  • parents with children who intend to leave the participating center in < 12 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890681


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21218
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Duke University Medical Center, Department of Community and Family Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Sara Benjamin Neelon, PhD, RD, MPH Johns Hopkins University
Principal Investigator: Truls Ostbye, MD/PhD Duke University
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01890681     History of Changes
Other Study ID Numbers: Pro00039195
R01DK093838 ( U.S. NIH Grant/Contract )
First Submitted: June 27, 2013
First Posted: July 2, 2013
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
childhood obesity
child care
infant
toddler

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