- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567252
Tanglewood to Table: A Walking Farmer's Market Group and Control
July 1, 2021 updated by: Dawn Brewer
This program encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Thursday or Saturday.
The study aims to determine if walking to the market to receive vouchers improve health outcomes beyond controls who receive nutrition education.
Study Overview
Detailed Description
In the summer of 2018, community members of Whitesburg, Kentucky (KY) were recruited to join the Tanglewood to Table walking program, and community members of Harlan, KY were invited to serve as controls.
Each Thursday or Saturday, participants report whether or not they walked the 1 mile trail to the farmers market, how many steps the walked in the previous 7 days and they reported which fruits and vegetables they consumed the previous week.
The control group will receive nutrition education handouts.
The program is from June 2018 - January 2019.
Participants complete questionnaires about fruit and vegetable consumption and physical activity.
Participants also provided physical and biological measurements.
Recruiting for the 2018 Walking Program will begin in May.
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Over 18 years
- non-pregnant
- moderate to good health (able to walk approximately 1 mile)
Exclusion Criteria:
- under 18 years
- pregnant
- poor health (unable to walk approximately 1 mile)
- institutionalized adults
- impaired consent capacity
- prisoners
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Walking Group
Participants in this group will join an established walking group and travel by foot 1 kilometer to a local Farmer's Market.
They will also receive handouts about nutrition information and nutritional choices.
|
Participants will walk 1 kilometer to a Farmer's Market.
|
|
No Intervention: Non-Walking Group
Participants in this group will have no walking requirement.
They will receive handouts about nutrition information and nutritional choices.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fruit Intake
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey indicating the total servings of fruit consumed (possible answers range from 1 serving in 3 months to 3 servings per day).
Survey will be measured at baseline, 4 months, and 8 months.
Data will be presented as average servings of fruit per group over time.
|
Baseline, 4 months and 8 months
|
|
Vegetable Intake
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey indicating the total servings of vegetables consumed (possible answers range from 1 serving in 3 months to 3 servings per day).
Survey will be measured at baseline, 4 months, and 8 months.
Data will be presented as average servings of vegetables per group over time.
|
Baseline, 4 months and 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Understanding of Plant-based Nutrients
Time Frame: Baseline, 4 months and 8 months
|
Participants will be asked a question demonstrating their understanding of the importance of ingesting plant-based nutrients at baseline, 4 months, and 8 months into the study.
Possible answers are yes, no, or not sure.
Data will be presented as the percent of participants in each group that understood the importance of plant-based nutrients over time.
|
Baseline, 4 months and 8 months
|
|
Change in Believing in the Benefits of Plant-based Nutrients
Time Frame: Baseline, 4 months and 8 months
|
Participants will be asked a question demonstrating their appreciation of plant-based nutrients at baseline, 4 months, and 8 months into the study.
Possible answers are yes, no, or not sure.
Data will be presented as the percent of participants in each group that understood the importance of plant-based nutrients over time.
|
Baseline, 4 months and 8 months
|
|
Change in Believing in the Preventative Effects of Plant-based Nutrients
Time Frame: Baseline, 4 months and 8 months
|
Participants will be asked a question demonstrating their beliefs of plant-based nutrients at baseline, 4 months, and 8 months into the study.
Possible answers are yes, no, or not sure.
Data will be presented as the percent of participants in each group that understood the importance of plant-based nutrients over time.
|
Baseline, 4 months and 8 months
|
|
Change in Believing in the Role of a Healthy Diet in Protecting Health From Pollutants
Time Frame: Baseline, 4 months and 8 months
|
Participants will be asked a question demonstrating their beliefs that a healthy diet might protect health from environmental pollutants at baseline, 4 months, and 8 months into the study.
Possible answers are yes, no, or not sure.
Data will be presented as the percent of participants in each group that understood the importance of a healthy diet over time.
|
Baseline, 4 months and 8 months
|
|
Change in Knowledge of Which Foods Contain Phytonutrients
Time Frame: Baseline, 4 months and 8 months
|
Participants will be asked a question about which foods contain phytonutrients at baseline, 4 months, and 8 months into the study.
Possible answers are meat, dairy, plant foods, all foods, or don't know.
Data will be presented as the percent of participants in each group that correctly identified plant foods over time.
|
Baseline, 4 months and 8 months
|
|
Change in Knowledge of Environmental Pollutants
Time Frame: Baseline, 4 months and 8 months
|
Participants will be asked to identify environmental pollutants from a list at baseline, 4 months, and 8 months into the study.
Possible answers are polychlorinated biphenyls (PCBs), mercury, nitrites, all of those, none of those, or don't know.
Data will be presented as the percent of participants in each group that correctly identified all of those over time.
|
Baseline, 4 months and 8 months
|
|
Change in Days of Vigorous Exercise in the Last Week
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked a number of days of the last 7 days that they participating in vigorous activity including the following: heavy lifting, digging, aerobics, or fast bicycling or other.
Data will be presented as the average number of days of vigorous activity compared between groups over time
|
Baseline, 4 months and 8 months
|
|
Change in Days of Moderate Exercise in the Last Week
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked a number of days of the last 7 days that they participating in moderate activity including the following: light lifting, bicycling or other.
Data will be presented as the average number of days of moderate activity compared between groups over time.
|
Baseline, 4 months and 8 months
|
|
Change in Time Spent in Vigorous Exercise in the Last Week
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how much time in hours and minutes over the last 7 days that they participated in vigorous activity including the following: heavy lifting, digging, aerobics, or fast bicycling or other.
Data will be presented as the average number of minutes or hours of vigorous activity compared between groups over time.
|
Baseline, 4 months and 8 months
|
|
Change in Time Spent in Moderate Exercise in the Last Week
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how much time in hours and minutes over the last 7 days that they participated in moderate activity including the following: lifting, bicycling or other.
Data will be presented as the average number of minutes or hours of moderate activity compared between groups over time.
|
Baseline, 4 months and 8 months
|
|
Change in Time Spent Walking
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how many days over the last 7 days that they walked for at least 10 minutes.
Data will be presented as the average number of minutes or hours of walking per day compared between groups over time.
|
Baseline, 4 months and 8 months
|
|
Change in Time Spent Sitting
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how many days over the last 7 days that they spent sitting.
Data will be presented as the average number of minutes or hours of sitting per day compared between groups over time.
|
Baseline, 4 months and 8 months
|
|
Change in Dark Green Vegetable Consumption
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 1.5 cups of dark green vegetables per week.
Answers will include: 0= No, and I do not intend to in the next 6 months, 1= No, but I intend to in the next 6 months, 2= No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months.
Data will be presented as the average intention to consume dark green vegetables compared between groups over time.
Scores range from 0-4; higher scores indicate increased consumption.
|
Baseline, 4 months and 8 months
|
|
Change in Red and Orange Vegetable Consumption
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 5.5 cups of red and orange vegetables per week.
Answers will include: 0=No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months.
Data will be presented as the average intention to consume red and orange vegetables compared between groups over time.
Scores range from 0-4; higher scores indicate increased consumption.
|
Baseline, 4 months and 8 months
|
|
Change in Fruit and Vegetable Consumption
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 5 cups of fruits and vegetables per week.
Answers will include: 0=No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months.
Data will be presented as the average intention to consume fruits and vegetables compared between groups over time.
Scores range from 0-4; higher scores indicate increased consumption.
|
Baseline, 4 months and 8 months
|
|
Change in Fruit Consumption
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 2 cups of fruits per week.
Answers will include: 0= No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, Y3=es, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months.
Data will be presented as the average intention to consume fruits compared between groups over time.
Scores range from 0-4; higher scores indicate increased consumption.
|
Baseline, 4 months and 8 months
|
|
Change in Walking 1 Mile Per Day
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they walk at least 1 mile per day.
Answers will include:0=No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4= Yes I have been for the past 6 months.
Data will be presented as the average intention to walk 1 mile per day compared between groups over time.
Scores range from 0-4; higher scores indicate increased walking.
|
Baseline, 4 months and 8 months
|
|
Change in Leisure Time and Physical Activity
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they get about 30 minutes of leisure time/recreational physical activity or exercise every day.
Answers will include: 0= No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months.
Data will be presented as the average intention to get 30 minutes of exercise every day compared between groups over time.
Scores range from 0-4; higher scores indicate increased activity.
|
Baseline, 4 months and 8 months
|
|
Change in General Health
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them to state if they consider their health to be: 0=poor, 1=fair, 2=good, 3=very good, or 4=excellent.
Data will be presented as the average ranking of individual health compared between groups over time.
Scores range from 0-4; higher scores indicate a higher perception of health.
|
Baseline, 4 months and 8 months
|
|
Change in Participation in Program
Time Frame: Baseline, 4 months and 8 months
|
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them why they decided to participate in the program.
Data will be presented as the number of participants that selected the most frequent answer ("to receive a farmer's market voucher").
|
Baseline, 4 months and 8 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Total Steps Taken Per Day
Time Frame: Baseline, 4 months and 8 months
|
Participants in the walking group will be issued pedometers to measure the total number of steps taken per day.
Data will be collected weekly for the duration of the study.
Data presented as the average number of steps per day.
|
Baseline, 4 months and 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2018
Primary Completion (Actual)
May 21, 2019
Study Completion (Actual)
May 21, 2019
Study Registration Dates
First Submitted
May 23, 2018
First Submitted That Met QC Criteria
June 12, 2018
First Posted (Actual)
June 25, 2018
Study Record Updates
Last Update Posted (Actual)
July 23, 2021
Last Update Submitted That Met QC Criteria
July 1, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 44215
- P42ES007380 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
It depends on the quality of data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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