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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Obesity	Behavioral: Baby NAP SACC; Behavioral: Back to Sleep	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	960 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Preventing Obesity in Infants and Toddlers in Child Care
Actual Study Start Date :	August 2013
Actual Primary Completion Date :	December 31, 2017
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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: center and family self-assessment,; center intervention materials delivered several times over the 6-month period, and;; 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: center and family self-assessment;; targeted technical assistance by Baby NAP SACC consultant for providers and parents;; training workshops for child care providers; and; parent outreach and support.	Behavioral: Baby NAP SACC

Outcome Measures

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Primary Outcome Measures :

1. change in weight-for-length z-score [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]
2. change in skinfold thickness [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]

Secondary Outcome Measures :

1. change in child physical activity via accelerometer [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]
2. change in child dietary intake [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]
3. change in child care policies and practices [ Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later) ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Benjamin Neelon SE, Østbye T, Hales D, Vaughn A, Ward DS. Preventing childhood obesity in early care and education settings: lessons from two intervention studies. Child Care Health Dev. 2016 May;42(3):351-8. doi: 10.1111/cch.12329. Epub 2016 Mar 14.

Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01890681 History of Changes
Other Study ID Numbers:	Pro00039195; R01DK093838 ( U.S. NIH Grant/Contract )
First Posted:	July 2, 2013
Last Update Posted:	January 5, 2018
Last Verified:	January 2018
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