Trial Outcomes & Findings for Tanglewood Trail Walking Program in Rural Kentucky 2017 (NCT NCT03495648)

NCT ID: NCT03495648

Last Updated: 2021-11-17

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

123 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2021-11-17

Participant Flow

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

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
60
61
Overall Study
COMPLETED
60
61
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tanglewood Trail Walking Program in Rural Kentucky 2017

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Walking Group (Low Engagers)
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. 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.
Walking Group (High Engagers)
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. 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.
Total
n=121 Participants
Total of all reporting groups
Age, Continuous
53.9 years
STANDARD_DEVIATION 14.7 • n=5 Participants
46.7 years
STANDARD_DEVIATION 14.7 • n=7 Participants
50.2 years
STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male
Female
35 Participants
n=5 Participants
37 Participants
n=7 Participants
72 Participants
n=5 Participants
Sex: Female, Male
Male
25 Participants
n=5 Participants
24 Participants
n=7 Participants
49 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
58 Participants
n=5 Participants
58 Participants
n=7 Participants
116 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
57 Participants
n=5 Participants
59 Participants
n=7 Participants
116 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
60 participants
n=5 Participants
61 participants
n=7 Participants
121 participants
n=5 Participants
Body Mass Index (BMI)
33.4 kg/m^2
STANDARD_DEVIATION 7.3 • n=5 Participants
33.4 kg/m^2
STANDARD_DEVIATION 7.0 • n=7 Participants
33.4 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
Diastolic Blood Pressure
80.6 mmHg
STANDARD_DEVIATION 9.3 • n=5 Participants
84.3 mmHg
STANDARD_DEVIATION 10.8 • n=7 Participants
82.5 mmHg
STANDARD_DEVIATION 10.2 • n=5 Participants
Systolic Blood Pressure
128.4 mmHg
STANDARD_DEVIATION 15.7 • n=5 Participants
129.1 mmHg
STANDARD_DEVIATION 18.0 • n=7 Participants
128.8 mmHg
STANDARD_DEVIATION 16.9 • n=5 Participants
Total Cholesterol
168.6 mg/dL
STANDARD_DEVIATION 34.8 • n=5 Participants
169.1 mg/dL
STANDARD_DEVIATION 37.4 • n=7 Participants
168.8 mg/dL
STANDARD_DEVIATION 36.0 • n=5 Participants
LDL Cholesterol
93.0 mg/dL
STANDARD_DEVIATION 25.9 • n=5 Participants
92.4 mg/dL
STANDARD_DEVIATION 27.3 • n=7 Participants
92.7 mg/dL
STANDARD_DEVIATION 26.5 • n=5 Participants
Total Cholesterol/HDL Ratio
4.2 ratio
STANDARD_DEVIATION 1.7 • n=5 Participants
4.1 ratio
STANDARD_DEVIATION 1.5 • n=7 Participants
4.1 ratio
STANDARD_DEVIATION 1.6 • n=5 Participants
Hemoglobin A1c
6.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3 • n=5 Participants
6.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.4 • n=7 Participants
6.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.4 • n=5 Participants
ASCVD (Atherosclerotic Cardiovascular Disease) Risk
11.2 risk
STANDARD_DEVIATION 14.2 • n=5 Participants
9.1 risk
STANDARD_DEVIATION 10.0 • n=7 Participants
10.2 risk
STANDARD_DEVIATION 12.4 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: No data were collected for 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

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 3 months

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.

Outcome measures

Outcome measures
Measure
Walking Group (Low Engagers)
n=36 Participants
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.
Walking Group (High Engagers)
n=51 Participants
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.
Change in A1c
-0.31 percent change
Standard Deviation 0.53
-0.20 percent change
Standard Deviation 0.52

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Outcome measures
Measure
Walking Group (Low Engagers)
n=39 Participants
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.
Walking Group (High Engagers)
n=50 Participants
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.
Change in LDL Cholesterol
-11.9 mg/dL
Standard Deviation 23.8
-12.7 mg/dL
Standard Deviation 17.5

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Walking Group (Low Engagers)
n=34 Participants
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.
Walking Group (High Engagers)
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. 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.
Change in HDL Cholesterol
Males
1.6 mg/dL
Standard Deviation 4.3
8.8 mg/dL
Standard Deviation 7.2
Change in HDL Cholesterol
Females
0.04 mg/dL
Standard Deviation 8.5
5.3 mg/dL
Standard Deviation 10.0

SECONDARY outcome

Timeframe: Baseline and 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

Outcome measures
Measure
Walking Group (Low Engagers)
n=39 Participants
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.
Walking Group (High Engagers)
n=50 Participants
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.
Change in Total Cholesterol
-14.8 mg/dL
Standard Deviation 32.5
-11.0 mg/dL
Standard Deviation 24.2

SECONDARY outcome

Timeframe: Baseline and 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

Outcome measures
Measure
Walking Group (Low Engagers)
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. 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.
Walking Group (High Engagers)
n=51 Participants
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.
Change in Weight
0.23 lb
Standard Deviation 5.4
-1.4 lb
Standard Deviation 11.8

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure
Walking Group (Low Engagers)
n=35 Participants
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.
Walking Group (High Engagers)
n=50 Participants
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.
Change in Waist Circumference
Male
-0.30 inches
Standard Deviation 1.3
-0.34 inches
Standard Deviation 2.1
Change in Waist Circumference
Female
-0.33 inches
Standard Deviation 2.3
-0.88 inches
Standard Deviation 3.8

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Not all participants completed this outcome measure.

Subjects' self-reported activity level will be measured as self-reported days of leisure physical activity per week.

Outcome measures

Outcome measures
Measure
Walking Group (Low Engagers)
n=26 Participants
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.
Walking Group (High Engagers)
n=35 Participants
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.
Change in Self-reported Activity Level
1.7 days of physical activity per week
Standard Deviation 2.6
1.4 days of physical activity per week
Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Not all participants completed this outcome measure.

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

Outcome measures

Outcome measures
Measure
Walking Group (Low Engagers)
n=25 Participants
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.
Walking Group (High Engagers)
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. 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.
Change in Self-reported Fruit and Vegetable Intake
1.0 servings of fruit and vegetables per day
Standard Deviation 4.2
2.4 servings of fruit and vegetables per day
Standard Deviation 2.7

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed this outcome measure.

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.

Outcome measures

Outcome measures
Measure
Walking Group (Low Engagers)
n=20 Participants
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.
Walking Group (High Engagers)
n=36 Participants
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.
Group Cohesion
130.2 score on a scale
Standard Deviation 53.1
155.3 score on a scale
Standard Deviation 40.7

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed the questionnaire.

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

Outcome measures
Measure
Walking Group (Low Engagers)
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. 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.
Walking Group (High Engagers)
n=55 Participants
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.
Understanding of Plant-based Phytonutrients
baseline
11 Participants
17 Participants
Understanding of Plant-based Phytonutrients
3 months
12 Participants
20 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed the questionnaire.

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

Outcome measures
Measure
Walking Group (Low Engagers)
n=25 Participants
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.
Walking Group (High Engagers)
n=28 Participants
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.
Belief in the Benefit of Plant-based Nutrients
baseline
7 Participants
12 Participants
Belief in the Benefit of Plant-based Nutrients
3 months
5 Participants
19 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed the questionnaire.

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

Outcome measures
Measure
Walking Group (Low Engagers)
n=24 Participants
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.
Walking Group (High Engagers)
n=27 Participants
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.
Belief in the Preventative Effects of Plant-Based Nutrients
baseline
8 Participants
11 Participants
Belief in the Preventative Effects of Plant-Based Nutrients
3 months
11 Participants
18 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed the questionnaire.

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

Outcome measures
Measure
Walking Group (Low Engagers)
n=23 Participants
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.
Walking Group (High Engagers)
n=27 Participants
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.
Belief in the Role of Healthy Diet in Protecting Health From Pollutants
baseline
6 Participants
9 Participants
Belief in the Role of Healthy Diet in Protecting Health From Pollutants
3 months
9 Participants
15 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed the questionnaire.

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

Outcome measures
Measure
Walking Group (Low Engagers)
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. 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.
Walking Group (High Engagers)
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. 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.
Knowledge of Which Foods Contain Phytonutrients
baseline
17 Participants
17 Participants
Knowledge of Which Foods Contain Phytonutrients
3 months
13 Participants
27 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Not all participants completed the questionnaire.

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

Outcome measures
Measure
Walking Group (Low Engagers)
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. 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.
Walking Group (High Engagers)
n=51 Participants
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.
Knowledge of Environmental Pollutants
baseline
13 Participants
22 Participants
Knowledge of Environmental Pollutants
3 months
8 Participants
15 Participants

Adverse Events

Walking Group (Low Engagers)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Walking Group (High Engagers)

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

Ann Koempel

University of Kentucky

Phone: (859) 257-3800

Results disclosure agreements

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