Trial Outcomes & Findings for Tanglewood Trail Walking Program in Rural Kentucky 2019 (NCT NCT05002972)

NCT ID: NCT05002972

Last Updated: 2021-11-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 63 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-11-04

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	63
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Tanglewood Trail Walking Program in Rural Kentucky 2019

Baseline characteristics by cohort

Measure	Walking Group n=61 Participants 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.
Age, Continuous	50.8 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Measure	Walking Group n=63 Participants 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.
Carotenoid Levels baseline	148.7 relative units (absorbance) Standard Deviation 65.7
Carotenoid Levels post-study	176.4 relative units (absorbance) Standard Deviation 69.3

PRIMARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure

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.

Outcome measures

Measure	Walking Group n=62 Participants 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.
Self-reported Fruit Intake baseline	1.8 servings of fruit per day Standard Deviation 1.6
Self-reported Fruit Intake post-study	1.7 servings of fruit per day Standard Deviation 1.2

PRIMARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Measure	Walking Group n=62 Participants 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.
Self-reported Vegetable Intake baseline	4.2 servings of vegetables per day Standard Deviation 2.6
Self-reported Vegetable Intake post-study	4.1 servings of vegetables per day Standard Deviation 2.3

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=61 Participants 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.
A1c Levels baseline	5.6 percentage of glycated hemoglobin Standard Deviation 0.7
A1c Levels post-study	5.4 percentage of glycated hemoglobin Standard Deviation 0.9

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this study outcome.

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

Outcome measures

Measure	Walking Group n=46 Participants 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.
LDL Cholesterol Levels baseline	83.8 mg/dl Standard Deviation 31.8
LDL Cholesterol Levels post-study	85.9 mg/dl Standard Deviation 29.3

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=56 Participants 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.
HDL Cholesterol Levels baseline	47.3 mg/dl Standard Deviation 10.5
HDL Cholesterol Levels post-study	46.4 mg/dl Standard Deviation 11.1

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=60 Participants 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.
Total Cholesterol Levels baseline	161.8 mg/dl Standard Deviation 34.9
Total Cholesterol Levels post-study	170.8 mg/dl Standard Deviation 35.3

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=63 Participants 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.
Weight baseline	205.3 pounds Standard Deviation 61.6
Weight post-study	207.8 pounds Standard Deviation 61.0

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=47 Participants 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.
Waist Circumference baseline	42.9 inches Standard Deviation 8.5
Waist Circumference post-study	43.1 inches Standard Deviation 8.3

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=52 Participants 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.
Hours of Vigorous Exercise baseline	2.2 hours per week Standard Deviation 2.0
Hours of Vigorous Exercise post-study	3.54 hours per week Standard Deviation 7.21

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=54 Participants 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.
Hours of Moderate Exercise baseline	4.6 hours per week Standard Deviation 11.1
Hours of Moderate Exercise post-study	2.4 hours per week Standard Deviation 2.1

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=58 Participants 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.
Hours of Sitting baseline	6.0 hours per week Standard Deviation 6.1
Hours of Sitting post-study	4.6 hours per week Standard Deviation 2.9

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=58 Participants 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.
Hours of Walking Per Week baseline	3.0 hours per week Standard Deviation 6.4
Hours of Walking Per Week post-study	3.8 hours per week Standard Deviation 12.3

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Measure	Walking Group n=62 Participants 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.
Understanding of Plant-based Phytonutrients baseline	42 Participants
Understanding of Plant-based Phytonutrients post-study	42 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Measure	Walking Group n=42 Participants 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.
Belief in the Benefit of Plant-based Nutrients baseline	41 Participants
Belief in the Benefit of Plant-based Nutrients post-study	40 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Measure	Walking Group n=42 Participants 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.
Belief in the Preventative Effects of Plant-Based Nutrients baseline	38 Participants
Belief in the Preventative Effects of Plant-Based Nutrients post-study	7 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Measure	Walking Group n=62 Participants 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.
Belief in the Role of Healthy Diet in Protecting Health From Pollutants baseline	56 Participants
Belief in the Role of Healthy Diet in Protecting Health From Pollutants post-study	48 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Measure	Walking Group n=62 Participants 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.
Knowledge of Which Foods Contain Phytonutrients baseline	42 Participants
Knowledge of Which Foods Contain Phytonutrients post-study	37 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Measure	Walking Group n=62 Participants 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.
Knowledge of Environmental Pollutants baseline	40 Participants
Knowledge of Environmental Pollutants post-study	36 Participants

Adverse Events

Walking Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dawn Brewer

University of Kentucky

Phone: 859-257-1661

Email: dawn.brewer@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place