Dietary HabitsNCT03775889
Engaging School and Family in Navajo Gardening for Health
A study testing Gardening in people with Dietary Habits and Eating Behavior, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This study builds on several years of working with Navajo communities to increase gardening and healthy eating. In collaboration with the Dream Diné Charter School in Shiprock, NM, the investigators propose to develop a school garden intervention to increase fruit and vegetable consumption and reduce risk for obesity… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dietary Habits, Eating Behavior, Health Behavior
- What is being tested?
- Gardening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2016to 13 Jun 2018
- 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
- Attending School Participating in Trial
- Parent able to Participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
This study builds on several years of working with Navajo communities to increase gardening and healthy eating. In collaboration with the Dream Diné Charter School in Shiprock, NM, the investigators propose to develop a school garden intervention to increase fruit and vegetable consumption and reduce risk for obesity among Navajo families. The intervention will integrate: an enhanced school garden plot; a curriculum for elementary school children on gardening and healthy eating; and family engagement in the curriculum and at community gardening fairs.
- Conditions
- Dietary Habits, Eating Behavior, Health Behavior
- Being tested
- Gardening
- Medical subject headings
- Feeding Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GardeningBehavioural
Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | Behavioral Gardening Exposure Receives: Behavioral: Gardening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child healthy eating behaviors assessment
Assess servings of vegetables and fruits eaten per week from the picture sort frequency method using the 5 a Day questions
Measured: 1 year
Secondary outcomes (2)
Child Gardening Participation Survey
Survey children to see if they have a garden at home, and if so how often they do gardening activities there
Measured: 1 year
Child Gardening Self-efficacy Survey
Survey children to identify how confident they are in their abilities to perform gardening behaviors, utilizing six-item likert scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start21 Oct 2016
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shirley Beresford, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775889
- Sponsor's protocol ID
- RG1001447
- Other IDs
- 8452
- Status last verified
- Apr 2019
- First submitted
- 12 Dec 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging School and Family in Navajo Gardening for Health
- ClinicalTrials.gov ID
- NCT03775889
- Acronym / sponsor ID
- RG1001447
- Conditions
- Dietary Habits, Eating Behavior, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 14 Dec 2018 (actual)
- 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.
This study builds on several years of working with Navajo communities to increase gardening and healthy eating. In collaboration with the Dream Diné Charter School in Shiprock, NM, the investigators propose to develop a school garden intervention to increase fruit and vegetable consumption and reduce risk for obesity among Navajo families. The intervention will integrate: an enhanced school garden plot; a curriculum for elementary school children on gardening and healthy eating; and family engagement in the curriculum and at community gardening fairs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: GardeningBehavioral Gardening Exposure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Attending School Participating in Trial
- Parent able to Participate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GardeningAssist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols | Behavioural | Behavioral |
Primary outcome
Child healthy eating behaviors assessment
Time frame: 1 year
Assess servings of vegetables and fruits eaten per week from the picture sort frequency method using the 5 a Day questions
2 secondary outcomes
Child Gardening Participation Survey
Time frame: 1 year
Child Gardening Self-efficacy Survey
Time frame: 1 year
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 16 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Shirley Beresford principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gardening in people with Dietary Habits and Eating Behavior, run by Fred Hutchinson Cancer Center at 1 site in United States.
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 2 inclusion and 0 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Child healthy eating behaviors assessment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2019.