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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03495648
Other study ID # 17-0283-P2H 2017
Secondary ID P42ES007380
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2017
Est. completion date September 24, 2020

Study information

Verified date November 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.


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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date September 24, 2020
Est. primary completion date September 24, 2020
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 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
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. 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. Baseline and 3 months
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. Baseline and 3 months
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. Baseline and 3 months
Secondary 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
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. 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. Baseline and 3 months
Secondary Change in Self-reported Fruit and Vegetable Intake Subjects' self-reported total servings of fruit and vegetable intake 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. 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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