Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town
Phase: NA
Conditions: Dietary Habits
Sponsor: Dawn Brewer

Tanglewood Trail Walking Program in Rural Kentucky 2017 
 
 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
05/16/17 
NCT Number: 
NCT03495648 
IRB Number 
17-0283-P2H (43453) 
Coversheet created: 
8/2/21 
 
 

IRB APPROVED 17-0283 
VALID 5.16.17-5.15.18

IRB APPROVED 17-0283 
VALID 5.16.17-5.15.18

IRB APPROVED 17-0283 
VALID 5.16.17-5.15.18

IRB APPROVED 17-0283 
VALID 5.16.17-5.15.18

F1.0100 
Form B:  Medical IRB Research Description 
 
 
 
               
 
               University of Kentucky 
 
 
 
 
                                         Revised 10/17/16 
1
 
1. Background:  The Tanglewood Trail walking group is a community-initiated walking group, spontaneously 
established in summer 2016.  Community members meet at the Housing Authority in Whitesburg, KY and 
walk the approximately 1 kilometer Tanglewood Trail connecting the Housing Authority to the Farmer’s 
Market. Participation in the walking group is open to the public. Participants that walk to the Farmer’s Market 
on Wednesday evenings receive a $5 voucher to the Farmer’s Market and a $10 voucher on Saturdays during 
the season (June-October). Adults 18 years and older receive one voucher each time they walk.  Currently, 
there is no evaluation of the walking group program beyond the community tracking the name, number of 
walkers, and the number of vouchers distributed to walkers on each Wednesday and Saturday. This program 
was initiated by community members and UK researchers were not involved with its creation or tracking any 
component of the program.   
   
The current proposed study will target non-pregnant healthy, 18+ years old, community members who are 
willing and able to walk the Tanglewood Trail on Saturday mornings, June-August 2017. Community 
members will be randomized into a walking group and a farmers market group.  Both groups will receive 
farmers market vouchers of equivalent value.  One group will meet at the Housing Authority and walk to the 
farmers market to obtain their vouchers and the other group will obtain their farmers market voucher at the 
farmers market.  Both groups are welcome to walk the Tanglewood Trail if they would like, however those 
that are randomized into the walking group are expected to walk.  However, people are not forced to walk and 
have the option to refuse to walk.  We hypothesize that adults who regularly attend the walking group and 
subsequently purchase fruits and vegetables at the Farmer’s Market will experience an increase in physical 
activity, fruit and vegetable intake, and community engagement, and a decrease in anthropometrics and 
biomarkers associated with adulthood chronic disease (including cholesterol, hemoglobin A1c, blood pressure, 
carotenoid status, weight, and waist circumference) beyond that of the farmers market voucher group only. 
   
2. Objectives:   
a) To educate Tanglewood Trail  program participants about the health benefits of consuming a variety 
of fruits and vegetables, being physically active, and dietary strategies that can help protect their 
health from environmental pollution. 
b) Assess self-reported behavior change, knowledge change, and change in physical measurements (see 
below), and level of physical activity. 
 
3. Study Design:  The sample population consists of a convenience sample that is participating in a prospective 
study. This study will focus on nonpregnant healthy adult (ages 18+) community members who walk the 
Tanglewood Trail on Saturdays, June-August 2017.  
Any interested community members who are 18 years or older, nonpregnant and able to voluntarily give their 
consent are welcome to join the study. One hundred participants will be randomized into one of two groups – a 
walking group and a farmer’s market group.  
The fifty participants randomized into the walking group will meet at the Housing Authority at a designated 
time each Saturday. When they arrive, they will be signed in by a community leader and receive a farmer’s 
market voucher (see attached) for $10 along with education material (5 of the 13 Saturdays). They will walk 
as a group to the farmer’s market and hand their voucher to the market manager, who will give them $10 in 
tokens to purchase fruits and vegetables at the market. The voucher will have two sides: one side will ask 
participants what fruits and vegetables they ate the past week; the second side will ask participants to check off 
what fruits and vegetables they purchase at the market that day. They will turn this in as they leave the market. 
The fifty participants randomized into the farmer’s market group will meet at- the farmer’s market and sign in 
with a UK employee. They will receive the same voucher and education materials and follow the same 
procedure as the walking group. Participants randomized into this group will be allowed to walk if they want; 
no one will be dissuaded from engaging in physical activity. However, in order to receive their voucher, it is 
not required for them to walk. 
Three times per month participants will be presented with education material concerning phytonutrients, the 
importance of fruit and vegetable intake, and how these factors might protect them from environmental 
pollutants. The education materials will be in the form of a.) a handout based on the Transtheoretical Model 

F1.0100 
Form B:  Medical IRB Research Description 
 
 
 
               
 
               University of Kentucky 
 
 
 
 
                                         Revised 10/17/16 
2
(see attached example) or b.) Plate it Up Kentucky Proud recipe samples and cards (see attached example). 
A Registered Dietitian will be available to answer nutrition-based health questions once per month.  
 
No participants will receive medications – neither real nor placebo.  
 
Data will be a time series collection of finger-stick total cholesterol, LDL, HDL, triglycerides, hemoglobin 
A1c (cardiocheck meter), height, weight, waist circumference, carotenoid status (carotenoid RS, which is a 
non-invasive instrument that is a reliable indicator of fruit and vegetable intake (see attached), and a survey 
(see attached). Measurements will be taken twice – baseline data will be collected in May 2017, with follow-
up data collected in early September 2017.  
 
Finger stick tests will be conducted by University of Kentucky employees who have completed all necessary 
biohazard training (see attached IBC approval and certificates of completion). Lysol wipes will be available to 
wipe down equipment as needed. Hand sanitizer will be provided to each researcher to use between glove 
changes. Gloves will be changed between each participant. Heat packets will be available for participants with 
cold hands to make the finger stick go faster and easier. Lancets will be used to take the finger stick and all 
materials will be disposed of in sharps containers. All sharps containers will remain sealed until the research 
team returns to the University of Kentucky that same day to dispose of the sharps containers. 
 
4. Study Population:  Based on walking group numbers from summer 2016 we anticipate a maximum 
enrollment of 100 participants (18+ years old, nonpregnant). Previous research in Letcher County suggests the 
majority of participants will be white, ages 18-65, both male and female, of moderate health status. A 
prerequisite for participating in this study is the ability to walk approximately 1 kilometer to the Farmer’s 
Market, nonpregnant,  pre-supposing a baseline health status. Any interested community members over the 
age of 18 and in moderate or good health will be included. Since our focus is on changes in rates of chronic 
disease in adulthood, children will be excluded from study participation (but may walk the trail with their 
parents). Institutionalized adults, pregnant adults adults with impaired consent capacity, and prisoners will be 
excluded. No one will be excluded based on sex/gender or racial/ethnic identity.  
 
5. Subject Recruitment Methods and Privacy:  A community leader will build a facebook group in April 2017 
to help recruit subjects. Interested participants will be invited to an opening baseline data collection event in 
May 2017. Interested participants will be told about the study and that their involvement is completely 
voluntary. We will obtain consent from those that are interested in participating in the study.  We will then 
invite consented participants to fill out a survey and have the above measurements (see section 3) taken in 
return for a farmer’s market t-shirt. Participants will be randomized into one of the two groups, walking group 
or farmers market only group, and informed of their group in May, during baseline measurements.  
Privacy will be maintained through de-identification of all survey and measurement data. The surveys and 
measurement data sheets will contain a cover sheet that has a place to record the participant’s name. The next 
page will be where the first question is listed and a space for the survey code to be recorded. Once the survey 
has been coded the cover sheet will be removed from the post-surveys and shredded.  Participants will be 
asked to indicate which fruits and vegetables they purchased at the market on shopping card (see attached).  
The card will have a place for their name and they will give them to the community leader before leaving the 
market.  The community leader will collect these weekly and give them to UK researcher bi-weekly.  The 
shopping card data will be matched to participants’ measurement data on an electronic datasheet.  Once all of 
the data has been collected in September the electronic list of names will be replaced with a code to de-
identify participants, the cover sheets of the surveys that contain participant names will be shredded and the 
surveys and shopping cards will be stored securely in a locked drawer in the PI’s locked office.  The 
electronic data that is generated will be stored on a password protected computer.  Throughout the study, any 
study materials that contain participant names will be stored in a locked filing cabinet in the PI’s locked 
office.  In the event this data is published it will be done so by aggregating the data without identifying 
individuals. 

F1.0100 
Form B:  Medical IRB Research Description 
 
 
 
               
 
               University of Kentucky 
 
 
 
 
                                         Revised 10/17/16 
3
6. Informed Consent Process:  All study personnel that will obtain consent are listed in Form A. Participants 
will be told they can decide to stop their participation at any time.  The consent form will be read to any study 
participants with visual issues. UK study personnel will speak to study participants at an appropriate volume 
to be heard by study participants. Study personnel will ask if they are speaking loud enough, they will tell 
study participants to let them know when they need to speak up or slow down or repeat a question, and study 
personnel will be in tune to signs of study participants straining to hear.  
 
Consent will be obtained before physical measurements or survey data is collected. To obtain consent the UK 
study personnel will ask potential participants if they would like to participate in a research study that 
involves asking them questions about their health and diet and will also involve education material on 
phytonutrients, the importance of fruits and vegetables, and how these factors might protect them from 
environmental pollution. They will be told their participation is completely voluntary, and that they will be 
randomized into one of two groups. They will be informed that even if they are randomized into the farmer’s 
market group, they are still allowed to walk whenever and however often they like.  Those randomized to the 
walking group will be told that they are expected to walk each Saturday morning, but they will never be 
forced to walk and will be encouraged to abstain from walking on Saturdays when they do not feel well.  
They will also be told their survey answers will not be reported individually or with their name, but as 
anonymous aggregated data. Additionally, they will be told their participation is voluntary and they can 
withdraw from the study at any time and they do not have to answer any questions that they are not 
comfortable answering. If the participant agrees the consent form will be given to them and their signature 
obtained. The participant will be given a copy of an investigator-signed consent form.  
 
The UK study personnel will ask if the participant would like to move elsewhere to complete the survey and 
anthropometric/biological data collection. Study personnel will also explain that the consent forms and 
surveys will be stored separately in a locked drawer in the PI’s locked office and that an electronic file will be 
created that lists their name and survey code. This list will be destroyed following the collection and entry of 
post-survey data. Any electronic files generated from this study will be stored on a password protected 
computer. 
 
Obtaining consent and completing the survey will take approximately 15 minutes.  An additional 30 minutes 
will be needed to complete the anthropometric and biological measurements. 
 
The midline and post data will be collected in the same manner as the pre data. The UK study personnel will 
offer the same explanation of the survey and anthropometric/biological measurements and the same 
procedures will be followed, consent however will not be obtained again. The midline and post-surveys will 
contain a cover sheet that has a place to record the participant’s name. The next page will be where the first 
question is listed and a space for the survey code to be recorded. Once the survey has been coded the cover 
sheet will be removed from the midline and post-surveys and shredded once all data has been entered 
electronically. 
 
7. Research Procedures: Following IRB approval, beginning in May 2017 community members will show up to 
a designated location approximately 1 kilometer from the Farmer’s Market. Participants will fill out a survey 
and have anthropometric and biological measurements taken. Carotenoid status will be measured via 
carotenoid RS scanner.  Anthropometric data will be collected by UK researchers and include weight (digital 
scale), height (portable stadiometer), waist circumference (tape) and blood pressure (digital blood pressure 
machine) Finger stick tests will be conducted by University of Kentucky employees who have completed all 
necessary biohazard training. Lysol wipes will be available to wipe down equipment as needed. Hand sanitizer 
will be provided to each researcher to use between glove changes. Gloves will be changed between each 
participant. Heat packets will be available for participants with cold hands to make the finger stick go faster 
and easier. Lancets will be used to take the finger stick and all materials will be disposed of in sharps 
containers. All sharps containers will remain sealed until the research team returns to the University of 
Kentucky that same day to dispose of the sharps containers. 
 

F1.0100 
Form B:  Medical IRB Research Description 
 
 
 
               
 
               University of Kentucky 
 
 
 
 
                                         Revised 10/17/16 
4
In June through August 2017, participants in the walking group will continue to show up to the same location, 
be signed in by a community member, and walk approximately 1 kilometer to the Farmer’s Market, in 
exchange for $10 they can spend at the market. Participants in the farmer’s market group will show up to the 
farmer’s market, be signed in by a UK employee, and follow the same voucher protocol as the walking group. 
Three Saturdays of each month, participants from both groups will receive education material in the form of 
a.) handouts based on the Transtheoretical Model or b.) Plate it Up Kentucky Proud recipes samples and 
cards. A Registered Dietitian Nutritionist will be available at least one weekend of each month to answer 
nutrition-related questions.  
 
Post-data will be collected in September 2017; the same survey will be administered and participants will 
again have their anthropometric and biological measurements taken.  
 
No clinical care will be given as a part of this research study. 
 
8. Resources:   
 
PI – Dawn Brewer, PhD, RDN, LD 
Program Manager – Annie Koempel, RDN, LD 
Research assistant – Kelci McHugh 
Undergraduate research assistants  
Community Leader 
Community Stakeholder 
The PI, program manager, and research assistant will be responsible for all data collection and analysis. All 
education materials will be developed by the program manager and research assistant with oversite by the PI. 
The program manager and undergraduate research assistants will be USDA Good Agricultural Practices 
(GAP) trained to serve Plate it Up Kentucky Proud samples at one Farmer’s Market per month. 
Undergraduate research assistants will also assist in data entry as needed (they will complete CITI 
certification and be added to research personnel list before having access to data). The PI will provide 
guidance through the process. The PI has space to store all of the consent forms, paper surveys, shopping 
cards and measurement data sheets in a locked drawer in the PI’s locked office. All UK study personnel have 
computers and statistical analysis software to carry out research procedures, which are all password protected 
to secure any electronic files that are generated from this study. The PI has funds to purchase paper and food 
supplies and transportation to conduct the study.  
In the event that unanticipated problems or noncompliance issues occur or the situation arises that requires 
submission of protocol modifications or interim results, the PI will first consult the Office of Research 
Integrity’s website to determine action steps appropriate to the issue. If the PI still has questions she will 
contact the Office of Research Integrity to obtain the appropriate protocol to resolve a situation. 
 
9. Potential Risks:   
No physical, psychological, social, legal, cultural, or financial risks can be perceived from participating in this 
research. In the rare case that a dangerously high blood pressure or hemoglobin A1c is recorded, the 
participant will be referred immediately to the local emergency department for care. All foods prepared for 
the farmer’s market will be accompanied by a recipe card with ingredients. Potential allergens will be 
identified and communicated to all participants. Participants will not be forced to taste any food. 
Undergraduate research assistants will be GAP trained and knowledgeable about food safety issues. No 
participants will be discouraged from walking to the farmer’s market, regardless of which group they are 
randomized into. The only difference between the two groups is where they sign in; the walking group signs 
in 1 kilometer from the market, while the farmer’s market group signs in at the market. 
 

F1.0100 
Form B:  Medical IRB Research Description 
 
 
 
               
 
               University of Kentucky 
 
 
 
 
                                         Revised 10/17/16 
5
Finger stick tests will be conducted by University of Kentucky employees who have completed all necessary 
biohazard training. Lysol wipes will be available to wipe down equipment as needed. Hand sanitizer will be 
provided to each researcher to use between glove changes. Gloves will be changed between each participant. 
Heat packets will be available for participants with cold hands to make the finger stick go faster and easier. 
Lancets will be used to take the finger stick and all materials will be disposed of in sharps containers. All 
sharps containers will remain sealed until the research team returns to the University of Kentucky that same 
day to dispose of the sharps containers. 
 
A potential risk is a breach of confidentiality, which is minimal due to the study being voluntary, removing 
the signed consent form from the coded survey, shredding the cover sheet that contains names on the post-
surveys, storing shopping cards in a locked drawer in the PI’s locked office, deleting the document containing 
participant names and codes once the post-survey data has been coded, using a password protected computer, 
and storing any hard copies of study-related material in a locked drawer that is in a locked office. 
 
10. Safety Precautions:  Participation in every aspect of the intervention is voluntary. Participants do not 
have to respond to any survey questions that they are uncomfortable answering or participate in any 
anthropometric or biological measurements they are uncomfortable with. No one will be discouraged 
from engaging in physical activity. 
 
When identifiable data (names) is being collected it will be on the cover sheet or consent form of a survey and 
will be detached from survey data that will include a code that is linked to the participant. At the end of the 
study, the cover sheets will be deleted and consent forms will be stored separately from the surveys in a 
locked drawer in the PI’s locked office. The electronic list containing the names and survey codes will be 
deleted once all post-survey data is entered, which will be entered within a month following collection. 
However, the assigning of codes, and generating the electronic document that lists codes and names from 
surveys will occur the day of data collection at UK. 
 
The study population consists of adults ages 18 years or older who are in good enough health to walk 1 
kilometer to the farmer’s market. 
 
Finger stick tests will be conducted by University of Kentucky employees who have completed all necessary 
biohazard training. Lysol wipes will be available to wipe down equipment as needed. Hand sanitizer will be 
provided to each researcher to use between glove changes. Gloves will be changed between each participant. 
Heat packets will be available for participants with cold hands to make the finger stick go faster and easier. 
Lancets will be used to take the finger stick and all materials will be disposed of in sharps containers. All 
sharps containers will remain sealed until the research team returns to the University of Kentucky that same 
day to dispose of the sharps containers. 
 
 
11. Benefit vs. Risk:  Potential benefits include (but are not limited to) a decreased risk for high blood pressure, 
high blood glucose, and cardiovascular disease; a decrease in oxidative stress; a decrease in generalized 
inflammation; an increase in community engagement; an increase in physical activity, and an increase in 
overall fruit and vegetable consumption.  
 
There is no more than minimal risk to participants in this intervention with the benefits outweighing any risk.  
There is however, a potential risk of a breach in confidentiality, which is minimal due to the study being 
voluntary, removing the signed consent form/cover sheet from the coded pre/post surveys, deleting the 
document containing participant names and codes once the post-survey data has been coded, shredding the 
cover sheets attached to post-surveys with participants names, using a password protected computer, and 
storing any hard copies of study-related material in a locked drawer that is in a locked office. 
 
12. Available Alternative Treatment(s):  N/A   
  

F1.0100 
Form B:  Medical IRB Research Description 
 
 
 
               
 
               University of Kentucky 
 
 
 
 
                                         Revised 10/17/16 
6
13. Research Materials, Records, and Privacy:  Participants will be asked to fill out two surveys (May and 
September 2017).  The surveys contain questions about demographics, self-reported health, physical 
activity, fruit and vegetable consumption, and community engagement.  
 
      Participants will be asked to complete weekly shopping cards that will require them to mark which fruits and 
vegetables they purchased at the farmer’s market and what fruits and vegetables they ate over the past week. 
 
 
Participants will be asked for finger-stick total cholesterol, LDL, HDL, triglycerides, hemoglobin A1c (cardio 
check meter), height, weight, waist circumference, and carotenoid status (carotenoid RS, which is a non-
invasive instrument that is a reliable indicator of fruit and vegetable intake) twice (May and September 2017).  
 
The collected data will be collated and summarized without identification or attribution to the individual 
participants. All reports will only reveal aggregated summaries across participants. The surveys with attached 
consent forms will be collected and stored separately in a locked drawer in the PI’s locked office. An 
electronic document containing participant name and code will be generated and stored on a password 
protected computer. Following the collection of post-survey data and coding of the post-survey data the 
electronic document containing the names and codes will be deleted. To minimize risk of identification the 
consent forms will be removed from the survey and the survey will have a code written on it. The consent 
forms, shopping cards and surveys will not be stored together, but both will be in a locked drawer. 
 
The information collected will be used to assess whether walking 1 kilometer to the farmer’s market and 
spending approximately $10 at the market improves physical activity, fruit and vegetable intake, community 
engagement, and chronic disease-related biomarkers (i.e. cholesterol, A1c, etc). 
 
14. Confidentiality:  The collated data will only reveal summarized data without identifiable information. The 
de-identified data will be available electronically and stored on a password protected computer. The electronic 
document containing names with respective survey codes will be deleted after post-survey data has been 
collected and therefore will not be stored. The list will be deleted by January 2020. Any study materials and 
raw data will be retained for 6 years in a locked drawer within a locked office or on a password protected 
computer. The PI and program manager assigned to the project and involved in data collection will have 
access to these items. 
 
15. Payment:  Participants will be offered a farmer’s market t-shirt at the baseline data collection time (May 
2017) and a $10 gift card at post-data collection (September 2017) as well as the weekly $10 voucher to the 
farmer’s market.  
 
16. Costs to Subjects:  N/A  
  
17. Data and Safety Monitoring:  N/A the study does not have greater than minimal risk. 
 
18. Subject Complaints:  Participants can voice their concerns to the PI, Co-PIs, program manager, or the Office 
of Research Integrity, which is listed on the consent form.  
 
19. Research Involving Non-English Speaking Subjects or Subjects from a Foreign Culture:  N/A 
 
20. HIV/AIDS Research:  N/A   
 
21. PI-Sponsored FDA-Regulated Research:  N/A 

Tanglewood Trail Walking Program in Rural Kentucky 2017 - SAP 
Analyses were conducted using SAS v. 9.4 software. For the purposes of analyses, participants 
were categorized as low-engagers and high-engagers defined by a cut-point of having walked to 
the market three or more times during the program. High-engagers were those that walked 
9.0±17.2 times to the market and redeemed their vouchers 13.0±14.4 times throughout the 16-
week study (n= 60). Low-engagers were those that walked 1.0±0.47 times to the farmers market 
and redeemed their vouchers 11.0±37.0 times (n=61).  
 
Means and standard deviations or frequencies were calculated for each of the variables and 
measurements. Pre- to post-intervention differences within each group were examined using 
dependent t-tests and chi-square analyses as appropriate. 
 
Repeated measures ANOVA were conducted to compare the changes in measurements 
including  over time. Outcome variables included the finger-stick measurements, WC, BMI and 
blood pressure. Because fruit and vegetable consumption and physical activity are associated 
with improving blood lipids, blood pressure, glucose control and weight were included as 
independent variables in repeated measure analyses to determine if the significant changes in 
physical measurements were associated with fruit and vegetable consumption, walking or both.  
For each outcome variable, the following independent variables were included separately 
resulting in three different ANOVA-repeated measures analyses for each outcome variable: 1) 
the difference in self-reported fruit and vegetable intake from pre- to post-intervention; 2) 
voucher redemption rate; and 3) walking status (walked to the market >3 times or <3 times 
throughout duration of program). If any significant associations were detected then age, sex and 
race were added to analyses as independent variables. Significance level was set a priori at p 
<0.05 for all analyses.