Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/10/2012
Date assigned
14/11/2012
Last edited
12/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sara Benjamin Neelon

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Preventing obesity in infants and toddlers in child care

Acronym

Baby NAP SACC

Study hypothesis

Child care centers participating in the intervention would improve their practices and environments supporting nutrition and physical activity for young children.

Ethics approval

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

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Nutrition and physical activity to help prevent obesity

Intervention

The 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

A researcher-administered assessment of each centerÂ’s environment using the Environment and Policy Assessment and Observation instrument

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/03/2009

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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 type

Patient

Age group

Child

Gender

Both

Target number of participants

32

Participant exclusion criteria

Centers with an open or pending case of abuse or neglect on file with the state

Recruitment start date

01/03/2009

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United States of America

Trial participating centre

Duke University
Durham
27705
United States of America

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Government

Website

http://www.nichd.nih.gov/

Funders

Funder type

Government

Funder name

National Institutes of Health (USA) ref: F32DK80618

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24065371

Publication citations

Additional files

Editorial Notes

12/10/2016: Plain English summary added.