Baby NAP SACC Intervention Study

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by Duke University

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT01890681

First received: June 27, 2013

Last updated: August 1, 2016

Last verified: August 2016

History of Changes

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:

MedlinePlus related topics: Children's Health

U.S. FDA Resources

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: 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

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:

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

Eligibility


Ages Eligible for Study:	3 Months and older (Child, Adult, Senior)
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 3-18 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

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	443-287-4288	sara.neelon@jhu.edu
Contact: Shayna Clancy	919-668-4376	shayna.clancy@dm.duke.edu

Locations


United States, Maryland
Johns Hopkins University	Active, not recruiting
Baltimore, Maryland, United States, 21218
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: Shayna Clancy 919-668-4376 shayna.clancy@dm.duke.edu
Principal Investigator: Truls Ostbye, MD, PhD, MPH

Sponsors and Collaborators

Duke 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


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 1, 2016
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 September 30, 2016

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