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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01573845
Other study ID # 1R01HD065888-01
Secondary ID 1R01HD065888
Status Completed
Phase N/A
First received April 3, 2012
Last updated March 23, 2015
Start date September 2011
Est. completion date July 2013

Study information

Verified date March 2015
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The central hypothesis of The GREEN Project Lunch Box Study is that a school-based communication campaign that combines healthy eating and eco-friendly messages will improve the quality of foods that children bring from home to school more than a healthy eating campaign alone and compared to a control/delayed intervention condition at the end of one school year.


Description:

The proposed intervention seeks to improve the quality of foods brought to school from home by taking advantage of a natural synergy between healthy eating and eco-friendly behaviors to increase motivation to adopt healthy eating behaviors. The project involves the design, implementation and evaluation of a novel, school based communications campaign to simultaneously improve the nutrition quality and eco-friendliness of foods that elementary school children bring from home to school.

The intervention is a theory-based multi-channel communications campaign based on qualitative research with the target population: children in grades three and four in public schools in Eastern Massachusetts and their caregivers. Schools were randomized to one of three conditions: (1) a campaign that includes healthy eating and eco-friendly messages; (2) a campaign that includes healthy eating messages only; and (3) a delayed healthy eating eco-friendly campaign after serving as a control group. Foods brought from home and the packaging associated with those foods will be assessed at baseline and at the end of the school year using a photographic technique.

The primary outcome of interest is change in the number of servings of fruits and vegetables. Secondary outcomes will include changes in the quantity of sugar-sweetened beverages; changes in processed, energy-dense foods; and changes in sugar sweetened beverages brought from home. We will also be able to assess changes in trash associated with foods brought from home.


Recruitment information / eligibility

Status Completed
Enrollment 979
Est. completion date July 2013
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility CHILD PARTICIPANTS

Inclusion Criteria:

- 3rd or 4th grade student in participating classroom

- Brings food from home to school at least 3 days per week

Exclusion Criteria:

- Not a 3rd or 4th grade student

- Not enrolled in a participating classroom

- Does not bring food from home to school at least three days per week

PARENT/CARETAKER PARTICIPANTS

Inclusion Criteria:

- Child is a 3rd or 4th grade student in participating classroom

- Child brings food from home to school at least 3 days per week

Exclusion Criteria:

- Child is not a 3rd or 4th grade student

- Child is not enrolled in a participating classroom

- Child does not bring food from home to school at least three days per week

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy Eating + Eco-Friendly Campaign
Participants receive a 6-month school-based campaign that includes: A 22-lesson classroom curriculum Homework activities that involve the family Monthly parent newsletters A food shopping and packing guide for parents Food demonstrations A poster contest School wide announcements
Healthy Eating Campaign
Participants receive a 6-month school-based campaign that includes: A 22-lesson classroom curriculum Homework activities that involve the family Monthly parent newsletters A food shopping and packing guide for parents Food demonstrations A poster contest School wide announcements

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Tufts University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

References & Publications (2)

Goldberg JP, Folta SC, Eliasziw M, Koch-Weser S, Economos CD, Hubbard KL, Tanskey LA, Wright CM, Must A. Great Taste, Less Waste: a cluster-randomized trial using a communications campaign to improve the quality of foods brought from home to school by ele — View Citation

Hubbard KL, Must A, Eliasziw M, Folta SC, Goldberg J. What's in children's backpacks: foods brought from home. J Acad Nutr Diet. 2014 Sep;114(9):1424-31. doi: 10.1016/j.jand.2014.05.010. Epub 2014 Jul 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the quantity of fruit and vegetables brought from home to school 6 months No
Secondary Changes in the quantity of sugar-sweetened beverages brought from home to school 6 months No
Secondary Changes in the quantity of processed, energy-dense foods brought from home to school 6 months No
Secondary Changes in trash weight associated with foods brought from home to school 6 months No
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