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Tanglewood Trail Walking Program in Rural Kentucky 2019

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
NCT05002972
Enrollment
63
Registered
2021-08-12
Start date
2019-05-15
Completion date
2019-09-19
Last updated
2021-11-04

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 when compared to the driving group.

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.

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
NA
Intervention model
SINGLE_GROUP
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
Carotenoid Levels3 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.
Self-reported Fruit Intake3 monthsSubjects' 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.
Self-reported Vegetable Intake3 monthsSubjects' 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.

Secondary

MeasureTime frameDescription
Total Cholesterol Levels3 monthsSubjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol.
Weight3 monthsSubjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.
Waist Circumference3 monthsSubjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.
Hours of Vigorous Exercise3 monthsSubjects will self-report the number of hours spent in vigorous exercise per week.
Hours of Moderate Exercise3 monthsSubjects will self-report the number of hours spent in moderate exercise per week.
Hours of Sitting3 monthsSubjects will self-report the number of hours spent sitting per day.
A1c Levels3 monthsSubjects' A1c will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant A1c.
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.
Hours of Walking Per Week3 monthsSubjects will self-report the number of hours spent walking per week.
LDL Cholesterol Levels3 monthsSubjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.
HDL Cholesterol Levels3 monthsSubjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL

Countries

United States

Participant flow

Participants by arm

ArmCount
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. walking group led by a community organizer: Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
61
Total61

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicWalking Group
Age, Continuous50.8 years
STANDARD_DEVIATION 14.7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
55 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
2 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
55 Participants
Region of Enrollment
United States
61 participants
Sex: Female, Male
Female
44 Participants
Sex: Female, Male
Male
17 Participants

Adverse events

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

Outcome results

Primary

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

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupCarotenoid Levelsbaseline148.7 relative units (absorbance)Standard Deviation 65.7
Walking GroupCarotenoid Levelspost-study176.4 relative units (absorbance)Standard Deviation 69.3
Primary

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

Population: Not all participants completed this outcome measure

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupSelf-reported Fruit Intakebaseline1.8 servings of fruit per dayStandard Deviation 1.6
Walking GroupSelf-reported Fruit Intakepost-study1.7 servings of fruit per dayStandard Deviation 1.2
Primary

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

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupSelf-reported Vegetable Intakebaseline4.2 servings of vegetables per dayStandard Deviation 2.6
Walking GroupSelf-reported Vegetable Intakepost-study4.1 servings of vegetables per dayStandard Deviation 2.3
Secondary

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

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupA1c Levelsbaseline5.6 percentage of glycated hemoglobinStandard Deviation 0.7
Walking GroupA1c Levelspost-study5.4 percentage of glycated hemoglobinStandard Deviation 0.9
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 this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking GroupBelief in the Benefit of Plant-based Nutrientsbaseline41 Participants
Walking GroupBelief in the Benefit of Plant-based Nutrientspost-study40 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 this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking GroupBelief in the Preventative Effects of Plant-Based Nutrientsbaseline38 Participants
Walking GroupBelief in the Preventative Effects of Plant-Based Nutrientspost-study7 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 this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking GroupBelief in the Role of Healthy Diet in Protecting Health From Pollutantsbaseline56 Participants
Walking GroupBelief in the Role of Healthy Diet in Protecting Health From Pollutantspost-study48 Participants
Secondary

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

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupHDL Cholesterol Levelsbaseline47.3 mg/dlStandard Deviation 10.5
Walking GroupHDL Cholesterol Levelspost-study46.4 mg/dlStandard Deviation 11.1
Secondary

Hours of Moderate Exercise

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

Time frame: 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupHours of Moderate Exercisebaseline4.6 hours per weekStandard Deviation 11.1
Walking GroupHours of Moderate Exercisepost-study2.4 hours per weekStandard Deviation 2.1
Secondary

Hours of Sitting

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

Time frame: 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupHours of Sittingbaseline6.0 hours per weekStandard Deviation 6.1
Walking GroupHours of Sittingpost-study4.6 hours per weekStandard Deviation 2.9
Secondary

Hours of Vigorous Exercise

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

Time frame: 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupHours of Vigorous Exercisebaseline2.2 hours per weekStandard Deviation 2
Walking GroupHours of Vigorous Exercisepost-study3.54 hours per weekStandard Deviation 7.21
Secondary

Hours of Walking Per Week

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

Time frame: 3 months

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupHours of Walking Per Weekbaseline3.0 hours per weekStandard Deviation 6.4
Walking GroupHours of Walking Per Weekpost-study3.8 hours per weekStandard Deviation 12.3
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 this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking GroupKnowledge of Environmental Pollutantsbaseline40 Participants
Walking GroupKnowledge of Environmental Pollutantspost-study36 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 this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking GroupKnowledge of Which Foods Contain Phytonutrientsbaseline42 Participants
Walking GroupKnowledge of Which Foods Contain Phytonutrientspost-study37 Participants
Secondary

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

Population: Not all participants completed this study outcome.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupLDL Cholesterol Levelsbaseline83.8 mg/dlStandard Deviation 31.8
Walking GroupLDL Cholesterol Levelspost-study85.9 mg/dlStandard Deviation 29.3
Secondary

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

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupTotal Cholesterol Levelsbaseline161.8 mg/dlStandard Deviation 34.9
Walking GroupTotal Cholesterol Levelspost-study170.8 mg/dlStandard Deviation 35.3
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 this outcome measure.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Walking GroupUnderstanding of Plant-based Phytonutrientsbaseline42 Participants
Walking GroupUnderstanding of Plant-based Phytonutrientspost-study42 Participants
Secondary

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

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupWaist Circumferencebaseline42.9 inchesStandard Deviation 8.5
Walking GroupWaist Circumferencepost-study43.1 inchesStandard Deviation 8.3
Secondary

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

Population: Not all participants completed this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Walking GroupWeightbaseline205.3 poundsStandard Deviation 61.6
Walking GroupWeightpost-study207.8 poundsStandard Deviation 61

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