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| ID | Type | Description | Link |
|---|---|---|---|
| P42ES007380 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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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 when compared to the driving group.
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. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. The ClinicalTrials.gov record for the original trial in 2017 is NCT03495648.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking Group | Experimental | Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| walking group led by a community organizer | Behavioral | Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. |
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| Measure | Description | Time Frame |
|---|---|---|
| Carotenoid Levels | 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. | 3 months |
| Self-reported Fruit Intake | Subjects' self-reported fruit intake will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant self-reported fruit intake. | 3 months |
| Self-reported Vegetable Intake | Subjects' self-reported vegetable intake will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant self-reported vegetable intake. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| A1c Levels | Subjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c. | 3 months |
| LDL Cholesterol Levels | Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Brewer, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
No current plan to share data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Walking Group | Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Walking Group | Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Carotenoid Levels | 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. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | relative units (absorbance) | 3 months |
|
Adverse event data were not collected for this study.
Adverse event data were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Walking Group | Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Brewer | University of Kentucky | 859-257-1661 | dawn.brewer@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 1, 2019 | Sep 29, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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| 3 months |
| HDL Cholesterol Levels | Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL | 3 months |
| Total Cholesterol Levels | Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol. | 3 months |
| Weight | Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight. | 3 months |
| Waist Circumference | Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference. | 3 months |
| Hours of Vigorous Exercise | Subjects will self-report the number of hours spent in vigorous exercise per week. | 3 months |
| Hours of Moderate Exercise | Subjects will self-report the number of hours spent in moderate exercise per week. | 3 months |
| Hours of Sitting | Subjects will self-report the number of hours spent sitting per day. | 3 months |
| Hours of Walking Per Week | Subjects will self-report the number of hours spent walking per week. | 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | Self-reported Fruit Intake | Subjects' self-reported fruit intake will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant self-reported fruit intake. | Not all participants completed this outcome measure | Posted | Mean | Standard Deviation | servings of fruit per day | 3 months |
|
|
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| Primary | Self-reported Vegetable Intake | Subjects' self-reported vegetable intake will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant self-reported vegetable intake. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | servings of vegetables per day | 3 months |
|
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| Secondary | A1c Levels | Subjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 3 months |
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| Secondary | LDL Cholesterol Levels | Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL. | Not all participants completed this study outcome. | Posted | Mean | Standard Deviation | mg/dl | 3 months |
|
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| Secondary | HDL Cholesterol Levels | Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | mg/dl | 3 months |
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| Secondary | Total Cholesterol Levels | Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | mg/dl | 3 months |
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| Secondary | Weight | Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | pounds | 3 months |
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| Secondary | Waist Circumference | Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | inches | 3 months |
|
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| Secondary | Hours of Vigorous Exercise | Subjects will self-report the number of hours spent in vigorous exercise per week. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | hours per week | 3 months |
|
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| Secondary | Hours of Moderate Exercise | Subjects will self-report the number of hours spent in moderate exercise per week. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | hours per week | 3 months |
|
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| Secondary | Hours of Sitting | Subjects will self-report the number of hours spent sitting per day. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | hours per week | 3 months |
|
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| Secondary | Hours of Walking Per Week | Subjects will self-report the number of hours spent walking per week. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | hours per week | 3 months |
|
|
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| Secondary | 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. | Not all participants completed this outcome measure. | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | 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. | Not all participants completed this outcome measure. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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. | Not all participants completed this outcome measure. | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | 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 | Not all participants completed this outcome measure. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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. | Not all participants completed this outcome measure. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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. | Not all participants completed this outcome measure. | Posted | Count of Participants | Participants | 3 months |
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