ClinicalTrials.gg
CompletedNCT05002972Updated Nov 4, 2021Results posted

Tanglewood Trail Walking Program in Rural Kentucky 2019

An interventional study of walking group led by a community organizer in Dietary Habits, sponsored by Dawn Brewer. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by Dawn Brewer · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled May 2019, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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. 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.

02

Conditions studied

  • Dietary Habits

Keywords

  • farmers market
  • Appalachia
  • physical activity
  • fruit and vegetable voucher program
03

In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 63 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Dawn Brewer is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ability to walk 1 kilometer

Exclusion criteria

Exclusion Criteria:

  • pregnant
  • institutionalized adults
  • impaired consent ability
  • prisoners
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralwalking group led by a community organizer

    Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

Secondary outcomes

  1. A1c Levels

    Subjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c.

    Time frame: 3 months

  2. LDL Cholesterol Levels

    Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.

    Time frame: 3 months

  3. HDL Cholesterol Levels

    Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL

    Time frame: 3 months

  4. 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.

    Time frame: 3 months

  5. Weight

    Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.

    Time frame: 3 months

  6. Waist Circumference

    Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.

    Time frame: 3 months

  7. Hours of Vigorous Exercise

    Subjects will self-report the number of hours spent in vigorous exercise per week.

    Time frame: 3 months

  8. Hours of Moderate Exercise

    Subjects will self-report the number of hours spent in moderate exercise per week.

    Time frame: 3 months

  9. Hours of Sitting

    Subjects will self-report the number of hours spent sitting per day.

    Time frame: 3 months

  10. Hours of Walking Per Week

    Subjects will self-report the number of hours spent walking per week.

    Time frame: 3 months

  11. 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.

    Time frame: 3 months

  12. 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.

    Time frame: 3 months

  13. 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.

    Time frame: 3 months

  14. 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

    Time frame: 3 months

  15. 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.

    Time frame: 3 months

  16. 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.

    Time frame: 3 months

07

Results

Posted Nov 4, 2021

Participant flow

Participant flow — Overall Study
MilestoneWalking Group
Started63
Completed61
Not completed2
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryCarotenoid 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.

Time frame:
3 months
Reported as:
Mean · relative units (absorbance)
Carotenoid Levels
relative units (absorbance)Walking Group
baseline148.7 ± 65.7
post-study176.4 ± 69.3
PrimarySelf-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.

Time frame:
3 months
Reported as:
Mean · servings of fruit per day
Self-reported Fruit Intake
servings of fruit per dayWalking Group
baseline1.8 ± 1.6
post-study1.7 ± 1.2
PrimarySelf-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.

Time frame:
3 months
Reported as:
Mean · servings of vegetables per day
Self-reported Vegetable Intake
servings of vegetables per dayWalking Group
baseline4.2 ± 2.6
post-study4.1 ± 2.3
SecondaryA1c Levels

Subjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c.

Time frame:
3 months
Reported as:
Mean · percentage of glycated hemoglobin
A1c Levels
percentage of glycated hemoglobinWalking Group
baseline5.6 ± 0.7
post-study5.4 ± 0.9
SecondaryLDL Cholesterol Levels

Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.

Time frame:
3 months
Reported as:
Mean · mg/dl
LDL Cholesterol Levels
mg/dlWalking Group
baseline83.8 ± 31.8
post-study85.9 ± 29.3
SecondaryHDL Cholesterol Levels

Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL

Time frame:
3 months
Reported as:
Mean · mg/dl
HDL Cholesterol Levels
mg/dlWalking Group
baseline47.3 ± 10.5
post-study46.4 ± 11.1
SecondaryTotal Cholesterol Levels

Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol.

Time frame:
3 months
Reported as:
Mean · mg/dl
Total Cholesterol Levels
mg/dlWalking Group
baseline161.8 ± 34.9
post-study170.8 ± 35.3
SecondaryWeight

Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.

Time frame:
3 months
Reported as:
Mean · pounds
Weight
poundsWalking Group
baseline205.3 ± 61.6
post-study207.8 ± 61.0
SecondaryWaist Circumference

Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.

Time frame:
3 months
Reported as:
Mean · inches
Waist Circumference
inchesWalking Group
baseline42.9 ± 8.5
post-study43.1 ± 8.3
SecondaryHours of Vigorous Exercise

Subjects will self-report the number of hours spent in vigorous exercise per week.

Time frame:
3 months
Reported as:
Mean · hours per week
Hours of Vigorous Exercise
hours per weekWalking Group
baseline2.2 ± 2.0
post-study3.54 ± 7.21
SecondaryHours of Moderate Exercise

Subjects will self-report the number of hours spent in moderate exercise per week.

Time frame:
3 months
Reported as:
Mean · hours per week
Hours of Moderate Exercise
hours per weekWalking Group
baseline4.6 ± 11.1
post-study2.4 ± 2.1
SecondaryHours of Sitting

Subjects will self-report the number of hours spent sitting per day.

Time frame:
3 months
Reported as:
Mean · hours per week
Hours of Sitting
hours per weekWalking Group
baseline6.0 ± 6.1
post-study4.6 ± 2.9
SecondaryHours of Walking Per Week

Subjects will self-report the number of hours spent walking per week.

Time frame:
3 months
Reported as:
Mean · hours per week
Hours of Walking Per Week
hours per weekWalking Group
baseline3.0 ± 6.4
post-study3.8 ± 12.3
SecondaryUnderstanding 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.

Time frame:
3 months
Reported as:
Count of participants · Participants
Understanding of Plant-based Phytonutrients
ParticipantsWalking Group
baseline42
post-study42
SecondaryBelief 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.

Time frame:
3 months
Reported as:
Count of participants · Participants
Belief in the Benefit of Plant-based Nutrients
ParticipantsWalking Group
baseline41
post-study40
SecondaryBelief 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.

Time frame:
3 months
Reported as:
Count of participants · Participants
Belief in the Preventative Effects of Plant-Based Nutrients
ParticipantsWalking Group
baseline38
post-study7
SecondaryBelief 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

Time frame:
3 months
Reported as:
Count of participants · Participants
Belief in the Role of Healthy Diet in Protecting Health From Pollutants
ParticipantsWalking Group
baseline56
post-study48
SecondaryKnowledge 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.

Time frame:
3 months
Reported as:
Count of participants · Participants
Knowledge of Which Foods Contain Phytonutrients
ParticipantsWalking Group
baseline42
post-study37
SecondaryKnowledge 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.

Time frame:
3 months
Reported as:
Count of participants · Participants
Knowledge of Environmental Pollutants
ParticipantsWalking Group
baseline40
post-study36

Adverse events

Collected over Adverse event data were not collected for this study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Walking Group———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Walking Group
Mean50.8 ± 14.7
Sex: Female, Male
Sex: Female, Male(Participants)Walking Group
Female44
Male17
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Walking Group
Hispanic or Latino1
Not Hispanic or Latino55
Unknown or Not Reported5
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Walking Group
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American2
White55
More than one race0
Unknown or Not Reported3
Region of Enrollment
Region of Enrollment(participants)Walking Group
United States61
08

Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40506, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — No current plan to share data.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05002972
Lead sponsor
Dawn Brewer
Responsible party
Dawn Brewer (Assistant Professor, University of Kentucky) — Sponsor-investigator
First posted
Aug 12, 2021
Start date
May 15, 2019
Primary completion
Sep 19, 2019
Completion
Sep 19, 2019
Results posted
Nov 4, 2021
Last update
Nov 4, 2021

Study contacts

Dawn Brewer, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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