- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06438003
Improving Healthy Living Opportunities: Laurel HARVEST
February 12, 2026 updated by: Makenzie Barr-Porter
The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community.
The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies.
The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health.
Participants will engage in annual data collection to assess dietary quality and food security status.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
281
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University of Kentucky
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Resident of Laurel of Pike County
- Over 18 years of age
Exclusion Criteria:
- Pregnancy
- Non-English speaking
- Plans to move out of the counties within the next three years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Laurel County
Specialized services
|
Community members will complete data collection at the extension office or community partner location.
Extension cooking classes and helping to make raised bed gardens along with other area happenings will be offered to participants throughout the year with check-ins and reminders.
Data will be collected from study participants (regardless of the intervention decided) , at two time points, to include survey, dietary recall, and carotenoid scanner.
|
|
Active Comparator: Pike County
Extension services as usual
|
Community members will receive extension services as usual with Data collection on participants at two time points to assess changes in rates of food insecurity, dietary quality, and overall health conditions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in food security
Time Frame: Baseline (year 1) and year 3
|
Food Security Status will be measured at each time point by the 10-item United States Department of Agriculture (USDA) Household Food Security Module.
The questionnaire includes ten questions pertaining to food security that were designed to assess an individual's ability to obtain food directly to ensure having enough healthy food to eat.
The questions include items such as not having enough money to purchase food, inability to afford nutritious food, and skipping meals due to lack of sufficient money.
Answer choices include often, sometimes, never, and don't know.
Items will be scored Food security status is assigned as follows: raw score zero-High food security among adults, raw score 1-2-Marginal food security, raw score 3-5-Low food security, raw score 6-10-Very low food security.
For some reporting purposes, the food security status of the first two categories in combination will be described as food secure and the latter two as food insecure.
|
Baseline (year 1) and year 3
|
|
change in total Healthy Eating Index scores
Time Frame: Baseline (year 1) and year 3
|
The Healthy Eating Index is a measurement that can capture changes in the thirteen dietary components outlined in the Dietary Guidelines for Americans.
A maximum score-5 or 10 points- can be reached for each dietary component, depending on the component.
Points are awarded when the amounts consumed meets the standard for a particular dietary component.
Amounts that do not meet the standard get fewer points, with zero being the minimum score, and the maximum total Healthy Eating Index score is 100.
|
Baseline (year 1) and year 3
|
|
Change in Food and Physical Activity Questionnaire (FPAQ)
Time Frame: Baseline (year 1) and year 3
|
30 item questionnaire to collect self-reported behaviors pertaining to five domains: diet, physical activity, food safety, food security and food resource management.
The response options for each question are based on a Likert scale.
Each question is scored with higher scores indicating greater frequency of the behavior in question.
|
Baseline (year 1) and year 3
|
|
change in carotenoids
Time Frame: Baseline (year 1) and year 3
|
the VEGGIE METER™ will be used to measure dermal carotenoids using non-invasive RS Spectroscopy.
Carotenoids are a biological marker of fruit and vegetable consumption.
This non-invasive measurement of dermal carotenoids has been validated against the standard of serum carotenoids in adults.
To obtain the measurement, a subject places their pointer finger into the machine for 20 seconds while their finger is squeezed.
Three replicates will be taken per person at 20 seconds per replicate.
The VEGGIE METER™ scores dermal carotenoids on a scale of 0-850 with higher scores indicating higher intake.
|
Baseline (year 1) and year 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Makenzie Barr-Porter, PhD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 27, 2023
Primary Completion (Actual)
November 21, 2025
Study Completion (Actual)
November 21, 2025
Study Registration Dates
First Submitted
May 24, 2024
First Submitted That Met QC Criteria
May 24, 2024
First Posted (Actual)
May 31, 2024
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 64602
- 2022-68015-36497 (Other Grant/Funding Number: USDA NIFA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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