- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06822803
Effects of an Urban-gardening Nutrition Intervention for Food Insecure College Students (UGNIFICS)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33330
- Florida International University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be enrolled at FIU
- Age 18+ years old
- Literate in English
- Food insecure
Exclusion Criteria:
- Students who are student athletes
- Women who are pregnant or planning to become pregnant in the next 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gardening Nutrition Education Program
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.
|
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.
|
|
No Intervention: Control Group
Participants in this group did not receive the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of interventiont at 8 weeks
|
|
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.
|
From enrollment to the end of interventiont at 8 weeks
|
|
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.
|
From enrollment to the end of interventiont at 8 weeks
|
|
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.
|
From enrollment to the end of interventiont at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Mean Nutrition Knowledge Scores
Time Frame: From enrollment to the end of intervention at 8 weeks
|
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.
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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
|
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.
|
From enrollment to the end of intervention at 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-19-0134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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