Baby NAP SACC Intervention Study
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2015 by Duke University
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01890681
First received: June 27, 2013
Last updated: February 9, 2015
Last verified: January 2015
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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 |
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:
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 |
Eligibility| Ages Eligible for Study: | 3 Months and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890681
Contacts
| Contact: Sara Benjamin Neelon, PhD, MPH, RD | 919-681-6990 | sara.benjamin@dm.duke.edu | |
| Contact: Meghan Mayhew, MPH | 919-613-6311 | meghan.mayhew@duke.edu |
Locations
| 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: Meghan Mayhew, MPH 919-613-6311 meghan.mayhew@duke.edu | |
| Sub-Investigator: Truls Ostbye, MD, PhD, MPH | |
Sponsors and Collaborators
Duke University
Investigators
| Principal Investigator: | Sara Benjamin Neelon, PhD, RD, MPH | Duke University |
More Information
No publications provided
| 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: | February 9, 2015 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Duke University:
|
childhood obesity child care infant toddler |
ClinicalTrials.gov processed this record on March 03, 2015