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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03567252
Other study ID # 44215
Secondary ID P42ES007380
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2018
Est. completion date May 21, 2019

Study information

Verified date July 2021
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 157
Est. completion date May 21, 2019
Est. primary completion date May 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Walking Group
Participants will walk 1 kilometer to a Farmer's Market.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (2)

Lead Sponsor Collaborator
Dawn Brewer National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Total Steps Taken Per Day 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
Primary Fruit Intake 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
Primary Vegetable Intake 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 Change in Understanding of Plant-based Nutrients 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
Secondary Change in Believing in the Benefits of Plant-based Nutrients 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
Secondary Change in Believing in the Preventative Effects of Plant-based Nutrients 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
Secondary Change in Believing in the Role of a 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 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
Secondary Change in Knowledge of Which Foods Contain Phytonutrients 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
Secondary Change in Knowledge of Environmental Pollutants 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
Secondary Change in Days of Vigorous Exercise in the Last Week 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
Secondary Change in Days of Moderate Exercise in the Last Week 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
Secondary Change in Time Spent in Vigorous Exercise in the Last Week 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
Secondary Change in Time Spent in Moderate Exercise in the Last Week 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
Secondary Change in Time Spent Walking 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
Secondary Change in Time Spent Sitting 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
Secondary Change in Dark Green Vegetable Consumption 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
Secondary Change in Red and Orange Vegetable Consumption 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
Secondary Change in Fruit and Vegetable Consumption 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
Secondary Change in Fruit Consumption 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
Secondary Change in Walking 1 Mile Per Day 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
Secondary Change in Leisure Time and Physical Activity 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
Secondary Change in General Health 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
Secondary Change in Participation in Program 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
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