Submission date
27/11/2012
Registration date
13/12/2012
Last edited
13/12/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Retrospectively registered
? Protocol not yet added
? SAP not yet added
? Results not yet added and study completed for more than 2 years
? Raw data not yet added
Study completed

Plain English Summary

Background and study aims:
Current fruit and vegetable consumption in children is low. There are few studies which promote fruit and vegetable intake, which have targeted children in child care, despite the fact that younger children are more likely influenced by adults in an eating environment. The objective of this pilot study is to assess whether Watch Me Grow (WMG) can become a sustainable, inexpensive way to increase vegetable consumption in pre-schoolers while attending child care.

Who can participate?
Child care centers in North Carolina, which care for children between the ages of 3 – 5 years.

What does the study involve?
Child care centers were allocated to receiving the The Watch Me Grow (WMG) programme first, or receiving it at a later date. WMG is designed to encourage fruit and vegetable consumption among children in child care. Centers given the programme at a later date, received a garden and the curriculum materials, but not the regular technical assistance visits.

What are the possible benefits and risks of participating?
Centers will benefit from receipt of an on-site garden. Children enrolled at the center may benefit from increased consumption of fresh vegetables. To reduce the chance of harm, only non poisonous crops will be grown at the child care centers. There are no known risks of participating in the study.

Where is the study run from?
Duke University Medical Center, Durham, North Carolina, USA

When is the study starting and how long is it expected to run for?
The study began in March 2011 and is expected to run until November 2013.

Who is funding the study?
Duke University Medical Center, USA

Who is the main contact?
Rebecca Brouwer
Rebecca.brouwer@duke.edu

Study website

Contact information

Type

Scientific

Contact name

Dr Sara Benjamin Neelon

ORCID ID

Contact details

Duke University Medical Center
Box 104006
Durham
27710
United States of America

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Watch Me Grow: A garden-based pilot intervention to increase fruit and vegetable intake in preschoolers – a randomized controlled trial

Acronym

WMG

Study hypothesis

Children in intervention child care centers, compared with children in control centers, will increase their consumption of fruit and vegetables more from pre- to post-intervention.

Ethics approval(s)

Duke University Medical Center, 17 August 2010, ref: Pro00025325

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Quality of life

Patient information sheet

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

Condition

Child Nutrition

Intervention

Centers allocated 1:1 to WMG intervention or delayed WMG intervention.

We compare the Watch Me Grow (WMG) garden-based intervention to a delayed intervention. WMG is a crop-a-month curriculum and garden intervention designed to encourage fruit and vegetable consumption among children in child care.
The intervention includes
1. Nutritional counseling to providers on low-cost ways to increase fruits and vegetables on the child care menu
2. Delivery of a multi-disciplinary pilot curriculum promoting fresh produce to providers and children and
3. Assistance establishing child care center gardens to get providers and children excited about growing their own fresh crops

Centers in the delayed intervention will receive a garden and the curriculum materials, but will not receive regular technical assistance visits.

Intervention type

Other

Primary outcome measure

Servings of vegetables consumed by children in child care measured pre intervention and one month post intervention

Secondary outcome measures

Servings of vegetables served to children in child care measured pre intervention and one month post intervention

Overall study start date

03/01/2011

Overall study end date

11/01/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Center directors in North Carolina who care for at least 3 children between the ages of 3 and 5

Participant type(s)

Patient

Age group

Adult

Sex

Both

Target number of participants

20 Center Directors

Participant exclusion criteria

Center directors outside of North Carolina, or those who do not care for children between the ages of 3 and 5

Recruitment start date

03/01/2011

Recruitment end date

11/01/2013

Locations

Countries of recruitment

United States of America

Study participating centre

Duke University Medical Center
Durham
27710
United States of America

Sponsor information

Organisation

Duke University Medical Center (USA)

Sponsor details

c/o Sara Benjamin Neelon
Department of Community and Family Medicine
DUMC Box 104006
Durham
27710
United States of America

Sponsor type

Hospital/treatment centre

Website

http://www.dukemedicine.org/

ROR

https://ror.org/03njmea73

Funders

Funder type

Hospital/treatment centre

Funder name

Duke University Medical Center (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes