Health CommunicationNCT01573845
The GREEN Project Lunch Box Study
A study testing Healthy Eating + Eco-Friendly Campaign and Healthy Eating Campaign in people with Health Communication, run by Tufts University.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Communication
- What is being tested?
- Healthy Eating + Eco-Friendly Campaign and Healthy Eating Campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 979 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 3rd or 4th grade student in participating classroom
- Brings food from home to school at least 3 days per week
- Child is a 3rd or 4th grade student in participating classroom
- Child brings food from home to school at least 3 days per week
Who cannot join
- 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
- 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
About this study
Official title: The GREEN (Growing Right: Eating Eco-Friendly & Nutritious) Project Lunch Box Study
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.
Read the 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.
- Conditions
- Health Communication
- Being tested
- Healthy Eating + Eco-Friendly Campaign, Healthy Eating Campaign
- Keywords
- child, communication, diet, food, health communication, nutrition, parents, primary schools, school age population, school health
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating + Eco-Friendly CampaignBehavioural
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 CampaignBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Eating + Eco-Friendly Campaign | Experimental | Not described Receives: Behavioral: Healthy Eating + Eco-Friendly Campaign |
| Healthy Eating Campaign | Active comparator | Not described Receives: Behavioral: Healthy Eating Campaign |
| Control/Delayed Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the quantity of fruit and vegetables brought from home to school
Measured: 6 months
Secondary outcomes (3)
Changes in the quantity of sugar-sweetened beverages brought from home to school
Measured: 6 months
Changes in the quantity of processed, energy-dense foods brought from home to school
Measured: 6 months
Changes in trash weight associated with foods brought from home to school
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jeanne P Goldberg, PhD, RD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573845
- Sponsor's protocol ID
- 1R01HD065888-01
- Other IDs
- 1R01HD065888
- Status last verified
- Mar 2015
- First submitted
- 3 Apr 2012
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25037557Goldberg 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 elementary school children. Prev Med. 2015 May;74:103-10. doi: 10.1016/j.ypmed.2015.02.010. Epub 2015 Feb 28.
PubMed 25735605
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GREEN (Growing Right: Eating Eco-Friendly & Nutritious) Project Lunch Box Study
- ClinicalTrials.gov ID
- NCT01573845
- Acronym / sponsor ID
- 1R01HD065888-01
- Conditions
- Health Communication
- Keywords
- child, communication, diet, food, health communication, nutrition, parents, primary schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 979 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Eating + Eco-Friendly Campaign | Experimental | Behavioral: Healthy Eating + Eco-Friendly Campaign |
| Healthy Eating Campaign | Active comparator | Behavioral: Healthy Eating Campaign |
| Control/Delayed Intervention | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 3rd or 4th grade student in participating classroom
- Brings food from home to school at least 3 days per week
- Child is a 3rd or 4th grade student in participating classroom
- Child brings food from home to school at least 3 days per week
Key exclusion criteria (7 listed)
- 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
- Child is not a 3rd or 4th grade student
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Eating + Eco-Friendly CampaignParticipants 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 | Behavioural | Healthy Eating + Eco-Friendly Campaign |
| Healthy Eating CampaignParticipants 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 | Behavioural | Healthy Eating Campaign |
Primary outcome
Changes in the quantity of fruit and vegetables brought from home to school
Time frame: 6 months
3 secondary outcomes
Changes in the quantity of sugar-sweetened beverages brought from home to school
Time frame: 6 months
Changes in the quantity of processed, energy-dense foods brought from home to school
Time frame: 6 months
Changes in trash weight associated with foods brought from home to school
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Results publication: PubMed 25037557Hubbard 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.
- Results publication: PubMed 25735605Goldberg 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 elementary school children. Prev Med. 2015 May;74:103-10. doi: 10.1016/j.ypmed.2015.02.010. Epub 2015 Feb 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne P Goldberg, PhD, RD principal investigator
Tufts University
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Eating + Eco-Friendly Campaign and Healthy Eating Campaign in people with Health Communication, run by Tufts University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the quantity of fruit and vegetables brought from home to school (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01573845, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.