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

January 28, 2019 updated by: Johns Hopkins University

Preventing Obesity in Infants and Toddlers in Child Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

960

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • University of North Carolina Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center, Department of Community and Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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:

  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.
Behavioral: Back to Sleep
EXPERIMENTAL: 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.
Behavioral: Baby NAP SACC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in weight-for-length z-score
Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
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)
pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

Secondary Outcome Measures

Outcome Measure
Time Frame
change in child physical activity via accelerometer
Time Frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
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)
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)
pre to post-intervention (from baseline to post-intervention; approximately 8 months later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2013

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (ESTIMATE)

July 2, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00039195
  • R01DK093838 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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