Food InsecurityUGNIFICSNCT06822803
Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students
A study testing Gardening Nutrition Education Program in people with Food Insecurity and Obesity Prevention, run by Florida International University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an urban gardening nutrition education program can have positive health effects on food insecure college students. The main question it aims to answer is to determine whether an 8-week urban-gardening nutrition intervention can improve fruit and vegetable intake… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity, Obesity Prevention
- What is being tested?
- Gardening Nutrition Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 5 Aug 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be enrolled at FIU
- Age 18+ years old
- Literate in English
- Food insecure
Who cannot join
- Students who are student athletes
- Women who are pregnant or planning to become pregnant in the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33330
About this study
The goal of this clinical trial is to learn if an urban gardening nutrition education program can have positive health effects on food insecure college students. The main question it aims to answer is to determine whether an 8-week urban-gardening nutrition intervention can improve fruit and vegetable intake, nutrition knowledge, Body Mass Index (BMI) and body fat percentage in college students with food insecurity.
Participants will:
Read more
Fill out a questionnaire regarding demographics, food insecurity, fruit and vegetable intake, nutrition knowledge, self-efficacy and health beliefs.
Allow researchers to measure height, weight and body fat percentage Participate in a 1-hour education cooking or gardening session once a week for 8 weeks Receive text message reminders for meeting dates
- Conditions
- Food Insecurity, Obesity Prevention
- Being tested
- Gardening Nutrition Education Program
- Keywords
- College student food insecurity, Gardening nutrition intervention, college students, nutrition education, social cognitive theory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardening Nutrition Education ProgramBehavioural
This intervention was a 6-week Social Cognitive Theory based, urban gardening, cooking and nutrition education program designed to change health behavior mediators, fruit and vegetable intake, stress, and life satisfaction in food insecure college students.
| Study group | Role | What they receive |
|---|---|---|
| Gardening Nutrition Education Program | Experimental | Intervention group participants completed in person 1-hour educational sessions, once a week for 6 weeks, and completed the post test and anthropometric measurements on the 7th week. The sessions included nutrition education, recipes, cooking demos, home gardening tips, and a take home vertical garden. A satisfaction survey was also administered at the last educational session (week 6). Multiple weekly sessions were scheduled to accommodate the participants' schedules. Sessions were capped at 12 students to allow for a more personalized experience. Text messages were used weekly to remind the participants and confirm attendance for each session. Receives: Behavioral: Gardening Nutrition Education Program |
| Control Group | No intervention | Participants in this group did not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Mean Fruit and Vegetable Intake at 8 Weeks
Fruit and vegetable intake was measured using the National Cancer Institute's Fruit and Vegetable Screener as well as through a 1-item question, "Yesterday, how many servings of fruits and vegetables did you consume?" Higher numbers indicate higher levels of fruit and vegetable intake.
Measured: From enrollment to the end of interventiont at 8 weeks
Change from Baseline in the Mean Stress Scores at 8 Weeks
Stress levels was measured using Cohen's Perceived Stress Scale. Higher numbers indicate higher levels of stress.
Measured: From enrollment to the end of interventiont at 8 weeks
Change from Baseline in the Mean Life Satisfaction Scores at 8 Weeks
Life Satisfaction was measured using Diener's Quality of Life. Higher numbers indicate higher levels of life satisfaction.
Measured: From enrollment to the end of interventiont at 8 weeks
Change from Baseline in the Mean Body Mass Index Scores at 8 Weeks
Anthropometrics were collected from all participants using standard techniques. Height was measured barefoot by stadiometer and weight was measured barefoot by a digital scale, with empty pockets and without heavy clothing such as sweaters. Participants will also self-report their height and weight for reference. BMI was calculated using the standard equation using height (cm) and weight (kg) Higher numbers indicate higher BMI.
Measured: From enrollment to the end of interventiont at 8 weeks
Secondary outcomes (2)
Change from Baseline in the Mean Nutrition Knowledge Scores
Nutrition knowledge was measured using an adapted version of 20- item Dickson-Spillmann Consumer Oriented Nutrition Knowledge Survey (CoNKS). 10 population relevant True or False style questions were included. Higher numbers indicate higher levels of nutrition knowledge.
Measured: From enrollment to the end of intervention at 8 weeks
Change from Baseline in the Mean Self Efficacy, Outcome Expectation and Reciprocal Determinism
Behavior change was measured through Social Cognitive Theory constructs. These will be measured through Dewar's SCT constructs scales. Higher numbers indicate higher levels of self-efficacy, outcome expectations and reciprocal determinism.
Measured: From enrollment to the end of intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start5 Aug 2019
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Coccia, PhD, RD, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822803
- Sponsor's protocol ID
- IRB-19-0134
- Acronym
- UGNIFICS
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Feb 2025
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students
- ClinicalTrials.gov ID
- NCT06822803
- Acronym / sponsor ID
- UGNIFICS / IRB-19-0134
- Conditions
- Food Insecurity, Obesity Prevention
- Keywords
- College student food insecurity, Gardening nutrition intervention, college students, nutrition education, social cognitive theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 12 Feb 2025 (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.
The goal of this clinical trial is to learn if an urban gardening nutrition education program can have positive health effects on food insecure college students. The main question it aims to answer is to determine whether an 8-week urban-gardening nutrition intervention can improve fruit and vegetable intake, nutrition knowledge, Body Mass Index (BMI) and body fat percentage in college students with food insecurity.
Participants will:
Fill out a questionnaire regarding demographics, food insecurity, fruit and vegetable intake, nutrition knowledge, self-efficacy and health beliefs.
Allow researchers to measure height, weight and body fat percentage Participate in a 1-hour education cooking or gardening session once a week for 8 weeks Receive text message reminders for meeting dates
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gardening Nutrition Education Program | Experimental | Behavioral: Gardening Nutrition Education ProgramIntervention group participants completed in person 1-hour educational sessions, once a week for 6 weeks, and completed the post test and anthropometric measurements on the 7th week. The sessions included nutrition education, recipes, cooking demos, home gardening tips, and a take home vertical garden. A satisfaction survey was also administered at the last educational session (week 6). Multiple weekly sessions were scheduled to accommodate the participants' schedules. Sessions were capped at 12 students to allow for a more personalized experience. Text messages were used weekly to remind the participants and confirm attendance for each session. |
| Control Group | No intervention | –Participants in this group did not receive the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be enrolled at FIU
- Age 18+ years old
- Literate in English
- Food insecure
Key exclusion criteria (2 listed)
- Students who are student athletes
- Women who are pregnant or planning to become pregnant in the next 6 months
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 |
|---|---|---|
| Gardening Nutrition Education ProgramThis intervention was a 6-week Social Cognitive Theory based, urban gardening, cooking and nutrition education program designed to change health behavior mediators, fruit and vegetable intake, stress, and life satisfaction in food insecure college students. | Behavioural | Gardening Nutrition Education Program |
Primary outcome
Change from Baseline in the Mean Fruit and Vegetable Intake at 8 Weeks
Time frame: From enrollment to the end of interventiont at 8 weeks
Fruit and vegetable intake was measured using the National Cancer Institute's Fruit and Vegetable Screener as well as through a 1-item question, "Yesterday, how many servings of fruits and vegetables did you consume?" Higher numbers indicate higher levels of fruit and vegetable intake.
Change from Baseline in the Mean Stress Scores at 8 Weeks
Time frame: From enrollment to the end of interventiont at 8 weeks
Stress levels was measured using Cohen's Perceived Stress Scale. Higher numbers indicate higher levels of stress.
Change from Baseline in the Mean Life Satisfaction Scores at 8 Weeks
Time frame: From enrollment to the end of interventiont at 8 weeks
Life Satisfaction was measured using Diener's Quality of Life. Higher numbers indicate higher levels of life satisfaction.
Change from Baseline in the Mean Body Mass Index Scores at 8 Weeks
Time frame: From enrollment to the end of interventiont at 8 weeks
Anthropometrics were collected from all participants using standard techniques. Height was measured barefoot by stadiometer and weight was measured barefoot by a digital scale, with empty pockets and without heavy clothing such as sweaters. Participants will also self-report their height and weight for reference. BMI was calculated using the standard equation using height (cm) and weight (kg) Higher numbers indicate higher BMI.
2 secondary outcomes
Change from Baseline in the Mean Nutrition Knowledge Scores
Time frame: From enrollment to the end of intervention at 8 weeks
Change from Baseline in the Mean Self Efficacy, Outcome Expectation and Reciprocal Determinism
Time frame: From enrollment to the end of intervention at 8 weeks
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 12 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nutrition Education Program in people with Food Insecurity and Obesity Prevention, run by Florida International University 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 4 inclusion and 2 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 12 Feb 2025. 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?
Change from Baseline in the Mean Fruit and Vegetable Intake at 8 Weeks (time frame: From enrollment to the end of interventiont at 8 weeks). The study lists 4 primary outcomes in all. 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 12 Feb 2025.