Trial Outcomes & Findings for Tanglewood Trail Walking Program in Rural Kentucky 2020 (NCT NCT05002985)

NCT ID: NCT05002985

Last Updated: 2021-11-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-11-05

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	49
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	1

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	1

Baseline Characteristics

Data from 1 participant was not collected.

Baseline characteristics by cohort

Measure	Walking Group n=48 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	52.9 years STANDARD_DEVIATION 15.5 • n=48 Participants
Sex: Female, Male Female	13 Participants n=48 Participants
Sex: Female, Male Male	35 Participants n=48 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=47 Participants • Data from 1 participant was not collected.
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=47 Participants • Data from 1 participant was not collected.
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=47 Participants • Data from 1 participant was not collected.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=48 Participants
Race (NIH/OMB) Asian	0 Participants n=48 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=48 Participants
Race (NIH/OMB) Black or African American	2 Participants n=48 Participants
Race (NIH/OMB) White	46 Participants n=48 Participants
Race (NIH/OMB) More than one race	0 Participants n=48 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=48 Participants
Region of Enrollment United States	48 Participants n=48 Participants

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=48 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	2.2 servings of fruit per day Standard Deviation 1.3
Self-reported Fruit Intake post-study	2.4 servings of fruit per day Standard Deviation 1.7

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=48 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	4.7 servings per day Standard Deviation 2.5
Self-reported Vegetable Intake post-study	5.4 servings per day 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 in vigorous exercise per week.

Outcome measures

Measure	Walking Group n=37 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 Per Week baseline	2.5 hours per week Standard Deviation 1.9
Hours of Vigorous Exercise Per Week post-study	3.3 hours per week Standard Deviation 7.3

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=40 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 Per Week baseline	4.6 hours per week Standard Deviation 10.1
Hours of Moderate Exercise Per Week post-study	2.0 hours per week Standard Deviation 1.5

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=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.
Hours of Sitting Per Week baseline	5.6 hours per week Standard Deviation 6.5
Hours of Sitting Per Week post-study	5.2 hours per week Standard Deviation 6.4

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=43 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	3.3 hours per week Standard Deviation 6.2
Hours of Walking Per Week post-study	3.5 hours per week Standard Deviation 7.0

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=48 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	44 Participants
Understanding of Plant-based Phytonutrients post-study	41 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=49 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 post-study	41 Participants
Belief in the Benefit of Plant-based Nutrients baseline	43 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=43 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	40 Participants
Belief in the Preventative Effects of Plant-Based Nutrients post-study	38 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=44 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	41 Participants
Belief in the Role of Healthy Diet in Protecting Health From Pollutants post-study	21 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=48 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 poast-study	3 Participants
Knowledge of Which Foods Contain Phytonutrients baseline	2 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=48 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	32 Participants
Knowledge of Environmental Pollutants post-study	33 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