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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walking Group (Low Engagers) | Experimental | 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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| Walking Group (High Engagers) | Experimental | 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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| 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 |
|---|---|---|
| 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 |
| 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 |
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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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123 participants were enrolled, but two participants dropped out of the study within the first month due to lack of interest.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. |
| FG001 | 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. 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 (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. 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 | 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. | No data were collected for this outcome measure. | Posted | Baseline and 3 months |
|
Adverse event data were not collected during the course of this study.
Adverse event and mortality data were not collected during the course of 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 (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. 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 | |
|---|---|---|---|---|
| Ann Koempel | University of Kentucky | (859) 257-3800 | ann.koempel@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 | May 16, 2017 | 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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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 |
| BG001 | 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. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. |
| BG002 | Total | Total of all reporting groups |
| 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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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Total Cholesterol | Mean | Standard Deviation | mg/dL |
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| LDL Cholesterol | Mean | Standard Deviation | mg/dL |
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| Total Cholesterol/HDL Ratio | Mean | Standard Deviation | ratio |
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| Hemoglobin A1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| ASCVD (Atherosclerotic Cardiovascular Disease) Risk | The ASCVD (atherosclerotic cardiovascular disease) risk is a national guideline developed by the American College of Cardiology. It is a calculation of the 10-year risk of having a cardiovascular problem, such as a heart attack or stroke. This risk estimate considers age, sex, race, cholesterol levels, blood pressure, medication use, diabetic status, and smoking status, with a range from 0 to >20. Lower scores indicate lower risk of cardiovascular disease. | Mean | Standard Deviation | risk |
|
| 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. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. |
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent change | Baseline and 3 months |
|
|
|
| Secondary | Change in LDL Cholesterol | 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 outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 months |
|
|
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| Secondary | Change in HDL Cholesterol | Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL. | Data are shown by sex: low engagers (10 males and 24 females) and high engagers (11 male and 37 female). Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 months |
|
|
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| Secondary | 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. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline and 3 months |
|
|
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| Secondary | Change in 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 | lb | Baseline and 3 months |
|
|
|
| Secondary | 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. | Data are shown by sex: low engagers (10 male and 25 female) and high engagers (11 male and 39 female). Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | inches | Baseline and 3 months |
|
|
|
| Secondary | Change in Self-reported Activity Level | Subjects' self-reported activity level will be measured as self-reported days of leisure physical activity per week. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | days of physical activity per week | Baseline and 3 months |
|
|
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| Secondary | Change in Self-reported Fruit and Vegetable Intake | Subjects' self-reported total servings of fruit and vegetable intake per day. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | servings of fruit and vegetables per day | Baseline and 3 months |
|
|
|
| Secondary | 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. | Not all participants completed this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 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 the questionnaire. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 the questionnaire. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 the questionnaire. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 the questionnaire. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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 the questionnaire. | 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 the questionnaire. | Posted | Count of Participants | Participants | 3 months |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Females |
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| Female |
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| 3 months |
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| 3 months |
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| 3 months |
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| 3 months |
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| 3 months |
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| 3 months |
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