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Tanglewood Trail Walking Program in Rural Kentucky

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ClinicalTrials.gov Identifier: NCT03495648
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Dawn Brewer, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Dietary Habits Behavioral: walking group led by a community organizer Behavioral: Drive Not Applicable

Detailed 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. Recruiting for the 2018 Walking Program will begin in May.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: Walking Group
Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market.
Behavioral: walking group led by a community organizer
Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.

Active Comparator: Non-walking Group
Subjects will drive themselves to the farmer's market.
Behavioral: Drive
Subjects will drive to a local farmer's market.




Primary Outcome Measures :
  1. Change in carotenoid levels over time [ Time Frame: Baseline, 3 months, 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in A1c [ Time Frame: Baseline, 3 months, 6 months ]
    Subjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c.

  2. Change in LDL cholesterol [ Time Frame: Baseline, 3 months, 6 months ]
    Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.

  3. Change in HDL cholesterol [ Time Frame: Baseline, 3 months, 6 months ]
    Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL

  4. Change in total cholesterol [ Time Frame: Baseline, 3 months, 6 months ]
    Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol.

  5. Change in weight [ Time Frame: Baseline, 3 months, 6 months ]
    Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.

  6. Change in waist circumference [ Time Frame: Baseline, 3 months, 6 months ]
    Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.

  7. Change in knowledge-related survey questions [ Time Frame: Baseline, 6 months ]
    Subjects' knowledge of phytochemicals will be measured via knowledge-related survey questions to determine if walking combined with a voucher for fruits and vegetables changes participant knowledge.

  8. Change in self-reported activity level [ Time Frame: Baseline, 6 months ]
    Subjects' self-reported activity level will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant self-reported activity level.

  9. Change in self-reported fruit and vegetable intake [ Time Frame: Baseline, 6 months ]
    Subjects' self-reported fruit and vegetable intake will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant self-reported fruit and vegetable intake.

  10. Change in group cohesion [ Time Frame: Baseline, 6 months ]
    Subjects' group cohesion will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant group cohesion.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ability to walk 1 kilometer

Exclusion Criteria:

  • pregnant
  • institutionalized adults
  • impaired consent ability
  • prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495648


Contacts
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Contact: Annie Koempel 859-257-7784 ann.koempel@uky.edu
Contact: Dawn Brewer, PhD 859-257-1661 dawn.brewer@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Annie Koempel    859-257-7784    ann.koempel@uky.edu   
Sponsors and Collaborators
Dawn Brewer
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Principal Investigator: Dawn Brewer, PhD University of Kentucky
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Responsible Party: Dawn Brewer, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03495648    
Other Study ID Numbers: 17-0283-P2H
P42ES007380 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dawn Brewer, University of Kentucky:
farmers market
Appalachia
physical activity
fruit and vegetable voucher program