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

ISRCTN ISRCTN33733318
DOI https://doi.org/10.1186/ISRCTN33733318
Secondary identifying numbers N/A
Submission date
29/10/2012
Registration date
14/11/2012
Last edited
12/10/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Few interventions have focused on child care for obesity prevention, despite the fact that in most developed countries the majority of children under five years of age spend time in these settings. Even fewer of these interventions have targeted very young children. The aim of this study is to evaluate the ability of an intervention to improve the nutrition and physical activity environments and practices in child care centers serving infants and toddlers.

Who can participate?
Child care centers located in the Boston area where at least 50% of children are racial minorities (non-white)

What does the study involve?
Participating child care centers are randomly allocate to either the intervention group or the control group. In the intervention group, center directors assess their child care environments, select areas for improvement, and make changes with the help of a trained interventionist. Interventionists also provide training for all child care providers in the intervention centers. The training focuses on infant and toddler nutrition, physical activity for infants and toddlers, and working with parents to help prevent obesity in young children. Center environments are assessed at the start of the study and at the six-month follow up. Control groups centers receive the intervention after the end of the study.

What are the possible benefits and risks of participating?
Benefits of participation in the study include improving the child care environment and preventing the development of obesity in young children. The main risk of participation was the potential for breach of confidentiality.

Where is the study run from?
The study took place in 32 child care centers in Boston, Massachusetts, and was conducted by researchers at Harvard Medical School and Harvard Pilgrim Health Care (USA)

When is the study starting and how long is it expected to run for?
March to December 2009

Who is funding the study?
1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (USA)
2. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (USA)

Who is the main contact?
Dr Sara Benjamin Neelon

Contact information

Dr Sara Benjamin Neelon
Scientific

Duke University
2200 W Main St
DUMC 104006
Durham
27705
United States of America

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titlePreventing obesity in infants and toddlers in child care
Study acronymBaby NAP SACC
Study hypothesisChild care centers participating in the intervention would improve their practices and environments supporting nutrition and physical activity for young children.
Ethics approval(s)1. Institutional Review Board, Harvard Pilgrim Health Care, 07/03/2008 ref: HSC# 3.7.08
2. Institutional Review Board, Duke University Medical Center, 14/10/2009, ref: Pro00019220
ConditionNutrition and physical activity to help prevent obesity
InterventionThe intervention allowed child care centers to assess their nutrition and physical activity environments, select areas for improvement, and make changes with the help of a trained interventionist.

Control centers received a delayed intervention.
Intervention typeOther
Primary outcome measureA researcher-administered assessment of each center’s environment using the Environment and Policy Assessment and Observation instrument
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/03/2009
Overall study end date31/12/2009

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants32
Participant inclusion criteria1. Child care centers located in the Boston area
2. The Massachusetts licensing office classified them as a child care center and not a family child care home
3. At least 50% of children were racial minorities (non-white)
Participant exclusion criteriaCenters with an open or pending case of abuse or neglect on file with the state
Recruitment start date01/03/2009
Recruitment end date31/12/2009

Locations

Countries of recruitment

  • United States of America

Study participating centre

Duke University
Durham
27705
United States of America

Sponsor information

Eunice Kennedy Shriver National Institute of Child Health (NICHD) (USA)
Government

Bldg 31
Room 2A32, MSC 2425
31 Center Drive
Bethesda
20892-2425
United States of America

Website http://www.nichd.nih.gov/
ROR logo "ROR" https://ror.org/04byxyr05

Funders

Funder type

Government

National Institutes of Health (USA) ref: F32DK80618
Government organisation / National government
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2014 Yes No

Editorial Notes

12/10/2016: Plain English summary added.