Baby Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) Intervention Study
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ClinicalTrials.gov Identifier: NCT01890681 |
Recruitment Status
:
Active, not recruiting
First Posted
: July 2, 2013
Last Update Posted
: January 5, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Behavioral: Baby NAP SACC Behavioral: Back to Sleep | Not Applicable |
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 |

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:
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:
|
Behavioral: Baby NAP SACC |
- 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) ]
- 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) ]

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

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
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 |
Principal Investigator: | Sara Benjamin Neelon, PhD, RD, MPH | Johns Hopkins University | |
Principal Investigator: | Truls Ostbye, MD/PhD | Duke University |
Publications of Results:
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 Key Record Dates |
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 |