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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT01890681

Collaborator

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

960

Enrollment

Locations

Arms

Actual Duration (Months)

320

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual 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 :

Aug 1, 2013

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

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

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21218
2	University of North Carolina Chapel Hill	Chapel Hill	North Carolina	United States	27516
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01890681

Other Study ID Numbers:

Pro00039195
R01DK093838

First Posted:

Jul 2, 2013

Last Update Posted:

Jan 29, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Johns Hopkins University

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Jan 29, 2019