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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05002972
Other study ID # 17-0283-P2H 2019
Secondary ID P42ES007380
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2019
Est. completion date September 19, 2019

Study information

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

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date September 19, 2019
Est. primary completion date September 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - ability to walk 1 kilometer Exclusion Criteria: - pregnant - institutionalized adults - impaired consent ability - prisoners

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
walking group led by a community organizer
Subjects will walk 1 kilometer from a pre-determined point to a local 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
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. 3 months
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. 3 months
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. 3 months
Secondary A1c Levels Subjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c. 3 months
Secondary LDL Cholesterol Levels Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL. 3 months
Secondary 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
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. 3 months
Secondary Weight Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight. 3 months
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. 3 months
Secondary Hours of Vigorous Exercise Subjects will self-report the number of hours spent in vigorous exercise per week. 3 months
Secondary Hours of Moderate Exercise Subjects will self-report the number of hours spent in moderate exercise per week. 3 months
Secondary Hours of Sitting Subjects will self-report the number of hours spent sitting per day. 3 months
Secondary Hours of Walking Per Week Subjects will self-report the number of hours spent walking per week. 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. 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. 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. 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 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. 3 months
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. 3 months
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