Tanglewood Trail Walking Program in Rural Kentucky 2017

Dietary Habits Clinical Trial

Official title:

Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town

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
• 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
• 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

Related Conditions & MeSH terms

• Dietary Habits

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