Health Knowledge, Attitudes, PracticeNCT06438003
Improving Healthy Living Opportunities: Laurel HARVEST
A study testing Special Services and Services as Usual in people with Health Knowledge, Attitudes, Practice and Obesity, run by Makenzie Barr-Porter at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Obesity
- What is being tested?
- Special Services and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2023to 21 Nov 2025
- 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
- Resident of Laurel of Pike County
- Over 18 years of age
Who cannot join
- Pregnancy
- Non-English speaking
- Plans to move out of the counties within the next three years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Health Knowledge, Attitudes, Practice, Obesity
- Being tested
- Special Services, Services as Usual
- Keywords
- Health Equity, Food Insecurity, Rural
- Medical subject headings
- Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Special ServicesBehavioural
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.
Services as UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Laurel County | Experimental | Specialized services Receives: Behavioral: Special Services |
| Pike County | Active comparator | Extension services as usual Receives: Other: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in food security
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.
Measured: Baseline (year 1) and year 3
change in total Healthy Eating Index scores
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.
Measured: Baseline (year 1) and year 3
Change in Food and Physical Activity Questionnaire (FPAQ)
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.
Measured: Baseline (year 1) and year 3
change in carotenoids
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.
Measured: Baseline (year 1) and year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start27 Jan 2023
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makenzie Barr-Porter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Makenzie Barr-Porter, University of Kentucky
- Investigators
- Makenzie Barr-Porter, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438003
- Sponsor's protocol ID
- 64602
- Other IDs
- 2022-68015-36497
- Status last verified
- Feb 2026
- First submitted
- 24 May 2024
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Healthy Living Opportunities: Laurel HARVEST
- ClinicalTrials.gov ID
- NCT06438003
- Acronym / sponsor ID
- 64602
- Conditions
- Health Knowledge, Attitudes, Practice, Obesity
- Keywords
- Health Equity, Food Insecurity, Rural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Makenzie Barr-PorterUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 31 May 2024 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laurel County | Experimental | Behavioral: Special ServicesSpecialized services |
| Pike County | Active comparator | Other: Services as UsualExtension services as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resident of Laurel of Pike County
- Over 18 years of age
Key exclusion criteria (3 listed)
- Pregnancy
- Non-English speaking
- Plans to move out of the counties within the next three years
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 |
|---|---|---|
| Special ServicesCommunity 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. | Behavioural | Laurel County |
| Services as UsualCommunity 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. | Other | Pike County |
Primary outcome
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.
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.
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.
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.
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 17 Feb 2026.
- 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.
Makenzie Barr-Porter, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Special Services and Services as Usual in people with Health Knowledge, Attitudes, Practice and Obesity, run by Makenzie Barr-Porter 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 3 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 17 Feb 2026. 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 in food security (time frame: Baseline (year 1) and year 3). 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 17 Feb 2026.