Tanglewood Trail Walking Program in Rural Kentucky 2017

Study Overview
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Brief Summary
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The Tanglewood Trail Walking Program is a well-established community health initiative that encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Saturday. The study aims to determine if walking to the market with a community health coach results in healthier options being selected at the market.

Detailed Description
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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.

Official Title
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Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town

Conditions
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Dietary Habits

Intervention / Treatment
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* Behavioral: walking group led by a community organizer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ability to walk 1 kilometer Exclusion Criteria: pregnant institutionalized adults impaired consent ability prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking Group (Low Engagers)<br>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. | Behavioral: walking group led by a community organizer<br>* Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.<br>|
| Experimental: Walking Group (High Engagers)<br>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. | Behavioral: walking group led by a community organizer<br>* Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Carotenoid Levels Over Time | 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. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1c | 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. | Baseline and 3 months | 
| Change in LDL Cholesterol | Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL. | Baseline and 3 months | 
| Change in HDL Cholesterol | Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL. | Baseline and 3 months | 
| Change in Total Cholesterol | Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol. | Baseline and 3 months | 
| Change in Weight | Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight. | Baseline and 3 months | 
| Change in Waist Circumference | Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference. | Baseline and 3 months | 
| Change in Self-reported Activity Level | Subjects' self-reported activity level will be measured as self-reported days of leisure physical activity per week. | Baseline and 3 months | 
| Change in Self-reported Fruit and Vegetable Intake | Subjects' self-reported total servings of fruit and vegetable intake per day. | Baseline and 3 months | 
| Group Cohesion | 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. | 3 months | 
| Understanding of Plant-based Phytonutrients | 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. | 3 months | 
| Belief in the Benefit of Plant-based Nutrients | 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. | 3 months | 
| Belief in the Preventative Effects of Plant-Based Nutrients | 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. | 3 months | 
| Belief in the Role of Healthy Diet in Protecting Health From Pollutants | 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. | 3 months | 
| Knowledge of Which Foods Contain Phytonutrients | 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. | 3 months | 
| Knowledge of Environmental Pollutants | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Appalachia, farmers market, physical activity, fruit and vegetable voucher program