Dietary HabitsNCT03495648
Tanglewood Trail Walking Program in Rural Kentucky 2017
A study testing walking group led by a community organizer in people with Dietary Habits, run by Dawn Brewer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dietary Habits
- What is being tested?
- walking group led by a community organizer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2017to 24 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to walk 1 kilometer
Who cannot join
- pregnant
- institutionalized adults
- impaired consent ability
- prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town
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.
Read the 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. The Walking Program was held June - Sept 2017. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements.
Although originally designed to compare data among walkers and non-walkers, the protocol was changed due to participant feasibility. Data were analyzed by comparing "low engagers" - those who walked to the market fewer than three times during the program - or "high engagers" - those who walked three or more times during the program. Data were collected at baseline and 3 months.
The data for years 2019 and 2020 of the Tanglewood to Trail walking program are registered separately in ClinicalTrials.gov.
- Conditions
- Dietary Habits
- Being tested
- walking group led by a community organizer
- Keywords
- farmers market, Appalachia, physical activity, fruit and vegetable voucher program
- Medical subject headings
- Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking group led by a community organizerBehavioural
Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
| Study group | Role | What they receive |
|---|---|---|
| Walking Group (Low Engagers) | Experimental | 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. Receives: Behavioral: walking group led by a community organizer |
| Walking Group (High Engagers) | Experimental | 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. Receives: Behavioral: walking group led by a community organizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Carotenoid Levels Over Time
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.
Measured: Baseline and 3 months
Secondary outcomes (15)
Change in A1c
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.
Measured: Baseline and 3 months
Change in LDL Cholesterol
Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.
Measured: Baseline and 3 months
Change in HDL Cholesterol
Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL.
Measured: Baseline and 3 months
Change in Total Cholesterol
Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol.
Measured: Baseline and 3 months
Change in Weight
Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.
Measured: Baseline and 3 months
Change in Waist Circumference
Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.
Measured: Baseline and 3 months
Change in Self-reported Activity Level
Subjects' self-reported activity level will be measured as self-reported days of leisure physical activity per week.
Measured: Baseline and 3 months
Change in Self-reported Fruit and Vegetable Intake
Subjects' self-reported total servings of fruit and vegetable intake per day.
Measured: Baseline and 3 months
Group Cohesion
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start30 May 2017
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dawn Brewer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor-investigator, Dawn Brewer, University of Kentucky
- Investigators
- Dawn Brewer, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495648
- Sponsor's protocol ID
- 17-0283-P2H 2017
- Other IDs
- P42ES007380
- Status last verified
- Nov 2021
- First submitted
- 19 Mar 2018
- Last updated
- 17 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tanglewood Trail Walking Program to Increase Phytonutrient Intake and Physical Activity in a Rural Kentucky Town
- ClinicalTrials.gov ID
- NCT03495648
- Acronym / sponsor ID
- 17-0283-P2H 2017
- Conditions
- Dietary Habits
- Keywords
- farmers market, Appalachia, physical activity, fruit and vegetable voucher program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Dawn BrewerUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 30 May 2017 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Posted 17 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. The Walking Program was held June - Sept 2017. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements.
Although originally designed to compare data among walkers and non-walkers, the protocol was changed due to participant feasibility. Data were analyzed by comparing "low engagers" - those who walked to the market fewer than three times during the program - or "high engagers" - those who walked three or more times during the program. Data were collected at baseline and 3 months.
The data for years 2019 and 2020 of the Tanglewood to Trail walking program are registered separately in ClinicalTrials.gov.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking Group (Low Engagers) | Experimental | Behavioral: walking group led by a community organizerSubjects 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 (High Engagers) | Experimental | Behavioral: walking group led by a community organizerSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ability to walk 1 kilometer
Key exclusion criteria (4 listed)
- pregnant
- institutionalized adults
- impaired consent ability
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking group led by a community organizerSubjects will walk 1 kilometer from a pre-determined point to a local farmer's market. | Behavioural | Walking Group (High Engagers), Walking Group (Low Engagers) |
Primary outcome
Change in Carotenoid Levels Over Time
Time frame: Baseline and 3 months
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.
15 secondary outcomes
Change in A1c
Time frame: Baseline and 3 months
Change in LDL Cholesterol
Time frame: Baseline and 3 months
Change in HDL Cholesterol
Time frame: Baseline and 3 months
Change in Total Cholesterol
Time frame: Baseline and 3 months
Change in Weight
Time frame: Baseline and 3 months
Change in Waist Circumference
Time frame: Baseline and 3 months
Change in Self-reported Activity Level
Time frame: Baseline and 3 months
Change in Self-reported Fruit and Vegetable Intake
Time frame: Baseline and 3 months
Group Cohesion
Time frame: 3 months
Understanding of Plant-based Phytonutrients
Time frame: 3 months
Belief in the Benefit of Plant-based Nutrients
Time frame: 3 months
Belief in the Preventative Effects of Plant-Based Nutrients
Time frame: 3 months
Belief in the Role of Healthy Diet in Protecting Health From Pollutants
Time frame: 3 months
Knowledge of Which Foods Contain Phytonutrients
Time frame: 3 months
Knowledge of Environmental Pollutants
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No current plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Brewer, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking group led by a community organizer in people with Dietary Habits, run by Dawn Brewer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Carotenoid Levels Over Time (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.