Dietary HabitsNCT05002985
Tanglewood Trail Walking Program in Rural Kentucky 2020
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 yearsHealthy volunteers can take part
- 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
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2020to 14 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
- Healthy volunteers accepted
- 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 when compared to the driving group.
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. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. The ClinicalTrials.gov record for the original trial in 2017 is NCT03495648.
- 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 | Experimental | Subjects will participate in a walking group led by a community organizer as a means to get to a local farmer's market. 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.
Self-reported Fruit Intake
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.
Measured: 3 months
Self-reported Vegetable Intake
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.
Measured: 3 months
Secondary outcomes (10)
Hours of Vigorous Exercise Per Week
Subjects will self-report the number of hours spent in vigorous exercise per week.
Measured: 3 months
Hours of Moderate Exercise Per Week
Subjects will self-report the number of hours spent in moderate exercise per week.
Measured: 3 months
Hours of Sitting Per Week
Subjects will self-report the number of hours spent sitting per day.
Measured: 3 months
Hours of Walking Per Week
Subjects will self-report the number of hours spent walking per week.
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 Aug 2021
- Study start17 May 2020
- Primary completion14 Sep 2020
- Study completion14 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT05002985
- Sponsor's protocol ID
- 17-0283-P2H 2020
- Other IDs
- P42ES007380
- Status last verified
- Oct 2021
- First submitted
- 10 Aug 2021
- Last updated
- 5 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 5 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
- NCT05002985
- Acronym / sponsor ID
- 17-0283-P2H 2020
- Conditions
- Dietary Habits
- Keywords
- farmers market, Appalachia, physical activity, fruit and vegetable voucher program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Dawn BrewerUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 17 May 2020 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Posted 5 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 when compared to the driving group.
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. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. The ClinicalTrials.gov record for the original trial in 2017 is NCT03495648.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking Group | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- 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 |
Primary outcome
Self-reported Fruit Intake
Time frame: 3 months
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.
Self-reported Vegetable Intake
Time frame: 3 months
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.
10 secondary outcomes
Hours of Vigorous Exercise Per Week
Time frame: 3 months
Hours of Moderate Exercise Per Week
Time frame: 3 months
Hours of Sitting Per Week
Time frame: 3 months
Hours of Walking Per Week
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 5 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 5 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 5 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?
Self-reported Fruit Intake (time frame: 3 months). The study lists 2 primary outcomes in all. 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 5 Nov 2021.