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

NCT ID: NCT01890681

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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:

1. center and family self-assessment,
2. center intervention materials delivered several times over the 6-month period, and;
3. parent handouts

After the intervention period, comparator centers will receive an abbreviated version of the Baby NAP SACC intervention.

Group Type ACTIVE_COMPARATOR

Back to Sleep

Intervention Type BEHAVIORAL

Baby NAP SACC

The intervention will include four complementary and mutually reinforcing components:

1. center and family self-assessment;
2. targeted technical assistance by Baby NAP SACC consultant for providers and parents;
3. training workshops for child care providers; and
4. parent outreach and support.

Group Type EXPERIMENTAL

Baby NAP SACC

Intervention Type BEHAVIORAL

Interventions

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Baby NAP SACC

Intervention Type BEHAVIORAL

Back to Sleep

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sara Benjamin Neelon, PhD, RD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Truls Ostbye, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center, Department of Community and Family Medicine

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Benjamin Neelon SE, Ostbye 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.

Reference Type RESULT
PMID: 26987658 (View on PubMed)

Hewitt L, Benjamin-Neelon SE, Carson V, Stanley RM, Janssen I, Okely AD. Child care centre adherence to infant physical activity and screen time recommendations in Australia, Canada and the United States: An observational study. Infant Behav Dev. 2018 Feb;50:88-97. doi: 10.1016/j.infbeh.2017.11.008. Epub 2017 Dec 7.

Reference Type RESULT
PMID: 29223777 (View on PubMed)

Other Identifiers

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R01DK093838

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00039195

Identifier Type: -

Identifier Source: org_study_id

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