The GREEN Project Lunch Box Study
| Tracking Information | |||||
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| First Received Date ICMJE | April 3, 2012 | ||||
| Last Updated Date | April 10, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Changes in the quantity of fruit and vegetables brought from home to school [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01573845 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The GREEN Project Lunch Box Study | ||||
| Official Title ICMJE | The GREEN (Growing Right: Eating Eco-Friendly & Nutritious) Project Lunch Box Study | ||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Health Communication | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 2200 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | CHILD PARTICIPANTS Inclusion Criteria:
Exclusion Criteria:
PARENT/CARETAKER PARTICIPANTS Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01573845 | ||||
| Other Study ID Numbers ICMJE | 1R01HD065888-01, 1R01HD065888 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tufts University | ||||
| Study Sponsor ICMJE | Tufts University | ||||
| Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Investigators ICMJE |
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| Information Provided By | Tufts University | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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