- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495648
Tanglewood Trail Walking Program in Rural Kentucky 2017
Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the summer of 2017, community members of Whitesburg, KY were recruited to join the Tanglewood Trail Walking Program to the Whitesburg farmers market. Each Saturday, participants reported whether or not they walked the 1-mile trail to the farmers market and they reported which fruits and vegetables they purchased. The Walking Program was held June - Sept 2017. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements.
Although originally designed to compare data among walkers and non-walkers, the protocol was changed due to participant feasibility. Data were analyzed by comparing "low engagers" - those who walked to the market fewer than three times during the program - or "high engagers" - those who walked three or more times during the program. Data were collected at baseline and 3 months.
The data for years 2019 and 2020 of the Tanglewood to Trail walking program are registered separately in ClinicalTrials.gov.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ability to walk 1 kilometer
Exclusion Criteria:
- pregnant
- institutionalized adults
- impaired consent ability
- prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Walking Group (Low Engagers)
Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.
Low engagers are defined as those participants who walked to the market two or fewer times during the program.
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Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
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Experimental: Walking Group (High Engagers)
Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.
High engagers are defined as those participants who walked to the market three or more times during the program.
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Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Carotenoid Levels Over Time
Time Frame: Baseline and 3 months
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Subjects' carotenoid status will be measured using a carotenoid Raman Spectroscopy to determine if walking combined with a voucher for fruits and vegetables increases intake in fruits and vegetables as measured by carotenoid status.
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Baseline and 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Understanding of Plant-based Phytonutrients
Time Frame: 3 months
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Participants will be asked a question demonstrating their understanding of the importance of ingesting plant-based nutrients.
Possible answers are yes, no, or not sure.
Data will be presented as the number of participants in each group that understood the importance of plant-based nutrients.
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3 months
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Belief in the Benefit of Plant-based Nutrients
Time Frame: 3 months
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Participants will be asked a question demonstrating their appreciation of plant-based nutrients.
Possible answers are yes, no, or not sure.
Data will be presented as the number of participants in each group that understood the importance of plant-based nutrients.
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3 months
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Belief in the Preventative Effects of Plant-Based Nutrients
Time Frame: 3 months
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Participants will be asked a question demonstrating their beliefs of plant-based nutrients.
Possible answers are yes, no, or not sure.
Data will be presented as the number of participants in each group that understood the importance of plant-based nutrients.
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3 months
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Knowledge of Which Foods Contain Phytonutrients
Time Frame: 3 months
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Participants will be asked a question about which foods contain phytonutrients.
Possible answers are meat, dairy, plant foods, all foods, or don't know.
Data will be presented as the number of participants in each group that correctly identified plant foods.
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3 months
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Knowledge of Environmental Pollutants
Time Frame: 3 months
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Participants will be asked to identify environmental pollutants from a list.
Possible answers are polychlorinated biphenyls (PCBs), mercury, nitrites, all of those, none of those, or don't know.
Data will be presented as the number of participants in each group that correctly identified all of those.
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3 months
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Change in A1c
Time Frame: Baseline and 3 months
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Subjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c.
Data were collected at baseline and 3 months and the difference will be calculated.
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Baseline and 3 months
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Change in LDL Cholesterol
Time Frame: Baseline and 3 months
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Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.
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Baseline and 3 months
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Change in HDL Cholesterol
Time Frame: Baseline and 3 months
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Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL.
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Baseline and 3 months
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Change in Total Cholesterol
Time Frame: Baseline and 3 months
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Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol.
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Baseline and 3 months
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Change in Weight
Time Frame: Baseline and 3 months
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Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.
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Baseline and 3 months
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Change in Waist Circumference
Time Frame: Baseline and 3 months
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Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.
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Baseline and 3 months
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Change in Self-reported Activity Level
Time Frame: Baseline and 3 months
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Subjects' self-reported activity level will be measured as self-reported days of leisure physical activity per week.
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Baseline and 3 months
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Change in Self-reported Fruit and Vegetable Intake
Time Frame: Baseline and 3 months
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Subjects' self-reported total servings of fruit and vegetable intake per day.
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Baseline and 3 months
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Group Cohesion
Time Frame: 3 months
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Subjects' group cohesion was measured post-intervention using the Physical Activity Group Environment Questionnaire" (also known as PAGE-Q).
There are 20 questions, ranked using a Likert Scale with 1 being "strongly disagree" and 9 "strongly agree."
Scores range from 20-180; higher scores indicate more social cohesion.
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3 months
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Belief in the Role of Healthy Diet in Protecting Health From Pollutants
Time Frame: 3 months
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Participants will be asked a question demonstrating their beliefs that a healthy diet might protect health from environmental pollutants.
Possible answers are yes, no, or not sure.
Data will be presented as the number of participants in each group that understood the importance of a healthy diet.
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3 months
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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
Other Study ID Numbers
- 17-0283-P2H 2017
- P42ES007380 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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