Skip to content

Tanglewood Trail Walking Program in Rural Kentucky 2017

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03495648
Enrollment
123
Registered
2018-04-12
Start date
2017-05-30
Completion date
2020-09-24
Last updated
2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Habits

Keywords

farmers market, Appalachia, physical activity, fruit and vegetable voucher program

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.

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. 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.

Interventions

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

Sponsors

National Institute of Environmental Health Sciences (NIEHS)
CollaboratorNIH
Dawn Brewer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* ability to walk 1 kilometer

Exclusion criteria

* pregnant * institutionalized adults * impaired consent ability * prisoners

Design outcomes

Primary

MeasureTime frameDescription
Change in Carotenoid Levels Over TimeBaseline and 3 monthsSubjects' 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

MeasureTime frameDescription
Change in LDL CholesterolBaseline and 3 monthsSubjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.
Change in HDL CholesterolBaseline and 3 monthsSubjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL.
Change in Total CholesterolBaseline and 3 monthsSubjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol.
Change in WeightBaseline and 3 monthsSubjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.
Change in Waist CircumferenceBaseline and 3 monthsSubjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.
Change in Self-reported Activity LevelBaseline and 3 monthsSubjects' self-reported activity level will be measured as self-reported days of leisure physical activity per week.
Change in Self-reported Fruit and Vegetable IntakeBaseline and 3 monthsSubjects' self-reported total servings of fruit and vegetable intake per day.
Change in A1cBaseline and 3 monthsSubjects' 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.
Understanding of Plant-based Phytonutrients3 monthsParticipants 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.
Belief in the Benefit of Plant-based Nutrients3 monthsParticipants 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.
Belief in the Preventative Effects of Plant-Based Nutrients3 monthsParticipants 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.
Belief in the Role of Healthy Diet in Protecting Health From Pollutants3 monthsParticipants 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.
Knowledge of Which Foods Contain Phytonutrients3 monthsParticipants 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.
Knowledge of Environmental Pollutants3 monthsParticipants 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.
Group Cohesion3 monthsSubjects' 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.

Countries

United States

Participant flow

Recruitment details

123 participants were enrolled, but two participants dropped out of the study within the first month due to lack of interest.

Participants by arm

ArmCount
Walking Group (Low Engagers)
Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. Low engagers are defined as those participants who walked to the market two or fewer times during the program. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
60
Walking Group (High Engagers)
Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. High engagers are defined as those participants who walked to the market three or more times during the program. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
61
Total121

Baseline characteristics

CharacteristicWalking Group (High Engagers)TotalWalking Group (Low Engagers)
Age, Continuous46.7 years
STANDARD_DEVIATION 14.7
50.2 years
STANDARD_DEVIATION 15
53.9 years
STANDARD_DEVIATION 14.7
ASCVD (Atherosclerotic Cardiovascular Disease) Risk9.1 risk
STANDARD_DEVIATION 10
10.2 risk
STANDARD_DEVIATION 12.4
11.2 risk
STANDARD_DEVIATION 14.2
Body Mass Index (BMI)33.4 kg/m^2
STANDARD_DEVIATION 7
33.4 kg/m^2
STANDARD_DEVIATION 7.1
33.4 kg/m^2
STANDARD_DEVIATION 7.3
Diastolic Blood Pressure84.3 mmHg
STANDARD_DEVIATION 10.8
82.5 mmHg
STANDARD_DEVIATION 10.2
80.6 mmHg
STANDARD_DEVIATION 9.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
58 Participants116 Participants58 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants5 Participants2 Participants
Hemoglobin A1c6.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.4
6.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.4
6.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3
LDL Cholesterol92.4 mg/dL
STANDARD_DEVIATION 27.3
92.7 mg/dL
STANDARD_DEVIATION 26.5
93.0 mg/dL
STANDARD_DEVIATION 25.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants3 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
59 Participants116 Participants57 Participants
Region of Enrollment
United States
61 participants121 participants60 participants
Sex: Female, Male
Female
37 Participants72 Participants35 Participants
Sex: Female, Male
Male
24 Participants49 Participants25 Participants
Systolic Blood Pressure129.1 mmHg
STANDARD_DEVIATION 18
128.8 mmHg
STANDARD_DEVIATION 16.9
128.4 mmHg
STANDARD_DEVIATION 15.7
Total Cholesterol169.1 mg/dL
STANDARD_DEVIATION 37.4
168.8 mg/dL
STANDARD_DEVIATION 36
168.6 mg/dL
STANDARD_DEVIATION 34.8
Total Cholesterol/HDL Ratio4.1 ratio
STANDARD_DEVIATION 1.5
4.1 ratio
STANDARD_DEVIATION 1.6
4.2 ratio
STANDARD_DEVIATION 1.7

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: Baseline and 3 months

Population: No data were collected for this outcome measure.

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.

Time frame: 3 months

Population: Not all participants completed the questionnaire.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking Group (Low Engagers)Belief in the Benefit of Plant-based Nutrientsbaseline7 Participants
Walking Group (Low Engagers)Belief in the Benefit of Plant-based Nutrients3 months5 Participants
Walking Group (High Engagers)Belief in the Benefit of Plant-based Nutrientsbaseline12 Participants
Walking Group (High Engagers)Belief in the Benefit of Plant-based Nutrients3 months19 Participants
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.

Time frame: 3 months

Population: Not all participants completed the questionnaire.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking Group (Low Engagers)Belief in the Preventative Effects of Plant-Based Nutrientsbaseline8 Participants
Walking Group (Low Engagers)Belief in the Preventative Effects of Plant-Based Nutrients3 months11 Participants
Walking Group (High Engagers)Belief in the Preventative Effects of Plant-Based Nutrientsbaseline11 Participants
Walking Group (High Engagers)Belief in the Preventative Effects of Plant-Based Nutrients3 months18 Participants
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.

Time frame: 3 months

Population: Not all participants completed the questionnaire.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking Group (Low Engagers)Belief in the Role of Healthy Diet in Protecting Health From Pollutantsbaseline6 Participants
Walking Group (Low Engagers)Belief in the Role of Healthy Diet in Protecting Health From Pollutants3 months9 Participants
Walking Group (High Engagers)Belief in the Role of Healthy Diet in Protecting Health From Pollutantsbaseline9 Participants
Walking Group (High Engagers)Belief in the Role of Healthy Diet in Protecting Health From Pollutants3 months15 Participants
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.

Time frame: Baseline and 3 months

ArmMeasureValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in A1c-0.31 percent changeStandard Deviation 0.53
Walking Group (High Engagers)Change in A1c-0.20 percent changeStandard Deviation 0.52
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.

Time frame: Baseline and 3 months

Population: Data are shown by sex: low engagers (10 males and 24 females) and high engagers (11 male and 37 female). Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in HDL CholesterolMales1.6 mg/dLStandard Deviation 4.3
Walking Group (Low Engagers)Change in HDL CholesterolFemales0.04 mg/dLStandard Deviation 8.5
Walking Group (High Engagers)Change in HDL CholesterolMales8.8 mg/dLStandard Deviation 7.2
Walking Group (High Engagers)Change in HDL CholesterolFemales5.3 mg/dLStandard Deviation 10
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.

Time frame: Baseline and 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in LDL Cholesterol-11.9 mg/dLStandard Deviation 23.8
Walking Group (High Engagers)Change in LDL Cholesterol-12.7 mg/dLStandard Deviation 17.5
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.

Time frame: Baseline and 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in Self-reported Activity Level1.7 days of physical activity per weekStandard Deviation 2.6
Walking Group (High Engagers)Change in Self-reported Activity Level1.4 days of physical activity per weekStandard Deviation 2.1
Secondary

Change in Self-reported Fruit and Vegetable Intake

Subjects' self-reported total servings of fruit and vegetable intake per day.

Time frame: Baseline and 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in Self-reported Fruit and Vegetable Intake1.0 servings of fruit and vegetables per dayStandard Deviation 4.2
Walking Group (High Engagers)Change in Self-reported Fruit and Vegetable Intake2.4 servings of fruit and vegetables per dayStandard Deviation 2.7
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.

Time frame: Baseline and 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in Total Cholesterol-14.8 mg/dLStandard Deviation 32.5
Walking Group (High Engagers)Change in Total Cholesterol-11.0 mg/dLStandard Deviation 24.2
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.

Time frame: Baseline and 3 months

Population: Data are shown by sex: low engagers (10 male and 25 female) and high engagers (11 male and 39 female). Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in Waist CircumferenceMale-0.30 inchesStandard Deviation 1.3
Walking Group (Low Engagers)Change in Waist CircumferenceFemale-0.33 inchesStandard Deviation 2.3
Walking Group (High Engagers)Change in Waist CircumferenceMale-0.34 inchesStandard Deviation 2.1
Walking Group (High Engagers)Change in Waist CircumferenceFemale-0.88 inchesStandard Deviation 3.8
Secondary

Change in Weight

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

Time frame: Baseline and 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Walking Group (Low Engagers)Change in Weight0.23 lbStandard Deviation 5.4
Walking Group (High Engagers)Change in Weight-1.4 lbStandard Deviation 11.8
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.

Time frame: 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureValue (MEAN)Dispersion
Walking Group (Low Engagers)Group Cohesion130.2 score on a scaleStandard Deviation 53.1
Walking Group (High Engagers)Group Cohesion155.3 score on a scaleStandard Deviation 40.7
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.

Time frame: 3 months

Population: Not all participants completed the questionnaire.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking Group (Low Engagers)Knowledge of Environmental Pollutantsbaseline13 Participants
Walking Group (Low Engagers)Knowledge of Environmental Pollutants3 months8 Participants
Walking Group (High Engagers)Knowledge of Environmental Pollutants3 months15 Participants
Walking Group (High Engagers)Knowledge of Environmental Pollutantsbaseline22 Participants
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.

Time frame: 3 months

Population: Not all participants completed the questionnaire.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking Group (Low Engagers)Knowledge of Which Foods Contain Phytonutrientsbaseline17 Participants
Walking Group (Low Engagers)Knowledge of Which Foods Contain Phytonutrients3 months13 Participants
Walking Group (High Engagers)Knowledge of Which Foods Contain Phytonutrientsbaseline17 Participants
Walking Group (High Engagers)Knowledge of Which Foods Contain Phytonutrients3 months27 Participants
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.

Time frame: 3 months

Population: Not all participants completed the questionnaire.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking Group (Low Engagers)Understanding of Plant-based Phytonutrientsbaseline11 Participants
Walking Group (Low Engagers)Understanding of Plant-based Phytonutrients3 months12 Participants
Walking Group (High Engagers)Understanding of Plant-based Phytonutrientsbaseline17 Participants
Walking Group (High Engagers)Understanding of Plant-based Phytonutrients3 months20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026