Dietary HabitsNCT03567252
Tanglewood to Table: A Walking Farmer's Market Group and Control
A study testing Walking Group in people with Dietary Habits, run by Dawn Brewer at 1 site in United States.
Trial summary
This program encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Thursday or Saturday. The study aims to determine if walking to the market to receive vouchers improve health outcomes beyond controls who receive nutrition education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dietary Habits
- What is being tested?
- Walking Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 21 May 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years
- non-pregnant
- moderate to good health (able to walk approximately 1 mile)
Who cannot join
- under 18 years
- pregnant
- poor health (unable to walk approximately 1 mile)
- institutionalized adults
- impaired consent capacity
- prisoners
Trial locations and contacts
1 site in 1 country.
About this study
This program encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Thursday or Saturday. The study aims to determine if walking to the market to receive vouchers improve health outcomes beyond controls who receive nutrition education.
Read the detailed description
In the summer of 2018, community members of Whitesburg, Kentucky (KY) were recruited to join the Tanglewood to Table walking program, and community members of Harlan, KY were invited to serve as controls. Each Thursday or Saturday, participants report whether or not they walked the 1 mile trail to the farmers market, how many steps the walked in the previous 7 days and they reported which fruits and vegetables they consumed the previous week. The control group will receive nutrition education handouts. The program is from June 2018 - January 2019. Participants complete questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. Recruiting for the 2018 Walking Program will begin in May.
- Conditions
- Dietary Habits
- Being tested
- Walking Group
- Keywords
- Appalachia, Exercise
- 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 GroupBehavioural
Participants will walk 1 kilometer to a Farmer's Market.
| Study group | Role | What they receive |
|---|---|---|
| Walking Group | Experimental | Participants in this group will join an established walking group and travel by foot 1 kilometer to a local Farmer's Market. They will also receive handouts about nutrition information and nutritional choices. Receives: Behavioral: Walking Group |
| Non-Walking Group | No intervention | Participants in this group will have no walking requirement. They will receive handouts about nutrition information and nutritional choices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit Intake
Participants will complete a survey indicating the total servings of fruit consumed (possible answers range from 1 serving in 3 months to 3 servings per day). Survey will be measured at baseline, 4 months, and 8 months. Data will be presented as average servings of fruit per group over time.
Measured: Baseline, 4 months and 8 months
Vegetable Intake
Participants will complete a survey indicating the total servings of vegetables consumed (possible answers range from 1 serving in 3 months to 3 servings per day). Survey will be measured at baseline, 4 months, and 8 months. Data will be presented as average servings of vegetables per group over time.
Measured: Baseline, 4 months and 8 months
Secondary outcomes (20)
Change in Understanding of Plant-based Nutrients
Participants will be asked a question demonstrating their understanding of the importance of ingesting plant-based nutrients at baseline, 4 months, and 8 months into the study. Possible answers are yes, no, or not sure. Data will be presented as the percent of participants in each group that understood the importance of plant-based nutrients over time.
Measured: Baseline, 4 months and 8 months
Change in Believing in the Benefits of Plant-based Nutrients
Participants will be asked a question demonstrating their appreciation of plant-based nutrients at baseline, 4 months, and 8 months into the study. Possible answers are yes, no, or not sure. Data will be presented as the percent of participants in each group that understood the importance of plant-based nutrients over time.
Measured: Baseline, 4 months and 8 months
Change in Believing in the Preventative Effects of Plant-based Nutrients
Participants will be asked a question demonstrating their beliefs of plant-based nutrients at baseline, 4 months, and 8 months into the study. Possible answers are yes, no, or not sure. Data will be presented as the percent of participants in each group that understood the importance of plant-based nutrients over time.
Measured: Baseline, 4 months and 8 months
Change in Believing in the Role of a 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 at baseline, 4 months, and 8 months into the study. Possible answers are yes, no, or not sure. Data will be presented as the percent of participants in each group that understood the importance of a healthy diet over time.
Measured: Baseline, 4 months and 8 months
Change in Knowledge of Which Foods Contain Phytonutrients
Participants will be asked a question about which foods contain phytonutrients at baseline, 4 months, and 8 months into the study. Possible answers are meat, dairy, plant foods, all foods, or don't know. Data will be presented as the percent of participants in each group that correctly identified plant foods over time.
Measured: Baseline, 4 months and 8 months
Change in Knowledge of Environmental Pollutants
Participants will be asked to identify environmental pollutants from a list at baseline, 4 months, and 8 months into the study. Possible answers are polychlorinated biphenyls (PCBs), mercury, nitrites, all of those, none of those, or don't know. Data will be presented as the percent of participants in each group that correctly identified all of those over time.
Measured: Baseline, 4 months and 8 months
Change in Days of Vigorous Exercise in the Last Week
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked a number of days of the last 7 days that they participating in vigorous activity including the following: heavy lifting, digging, aerobics, or fast bicycling or other. Data will be presented as the average number of days of vigorous activity compared between groups over time
Measured: Baseline, 4 months and 8 months
Change in Days of Moderate Exercise in the Last Week
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked a number of days of the last 7 days that they participating in moderate activity including the following: light lifting, bicycling or other. Data will be presented as the average number of days of moderate activity compared between groups over time.
Measured: Baseline, 4 months and 8 months
Change in Time Spent in Vigorous Exercise in the Last Week
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how much time in hours and minutes over the last 7 days that they participated in vigorous activity including the following: heavy lifting, digging, aerobics, or fast bicycling or other. Data will be presented as the average number of minutes or hours of vigorous activity compared between groups over time.
Measured: Baseline, 4 months and 8 months
Change in Time Spent in Moderate Exercise in the Last Week
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how much time in hours and minutes over the last 7 days that they participated in moderate activity including the following: lifting, bicycling or other. Data will be presented as the average number of minutes or hours of moderate activity compared between groups over time.
Measured: Baseline, 4 months and 8 months
Change in Time Spent Walking
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how many days over the last 7 days that they walked for at least 10 minutes. Data will be presented as the average number of minutes or hours of walking per day compared between groups over time.
Measured: Baseline, 4 months and 8 months
Change in Time Spent Sitting
Participants will complete a survey at baseline, 4 months, and 8 months where they will be asked how many days over the last 7 days that they spent sitting. Data will be presented as the average number of minutes or hours of sitting per day compared between groups over time.
Measured: Baseline, 4 months and 8 months
Change in Dark Green Vegetable Consumption
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 1.5 cups of dark green vegetables per week. Answers will include: 0= No, and I do not intend to in the next 6 months, 1= No, but I intend to in the next 6 months, 2= No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months. Data will be presented as the average intention to consume dark green vegetables compared between groups over time. Scores range from 0-4; higher scores indicate increased consumption.
Measured: Baseline, 4 months and 8 months
Change in Red and Orange Vegetable Consumption
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 5.5 cups of red and orange vegetables per week. Answers will include: 0=No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months. Data will be presented as the average intention to consume red and orange vegetables compared between groups over time. Scores range from 0-4; higher scores indicate increased consumption.
Measured: Baseline, 4 months and 8 months
Change in Fruit and Vegetable Consumption
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 5 cups of fruits and vegetables per week. Answers will include: 0=No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months. Data will be presented as the average intention to consume fruits and vegetables compared between groups over time. Scores range from 0-4; higher scores indicate increased consumption.
Measured: Baseline, 4 months and 8 months
Change in Fruit Consumption
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they eat at least 2 cups of fruits per week. Answers will include: 0= No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, Y3=es, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months. Data will be presented as the average intention to consume fruits compared between groups over time. Scores range from 0-4; higher scores indicate increased consumption.
Measured: Baseline, 4 months and 8 months
Change in Walking 1 Mile Per Day
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they walk at least 1 mile per day. Answers will include:0=No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4= Yes I have been for the past 6 months. Data will be presented as the average intention to walk 1 mile per day compared between groups over time. Scores range from 0-4; higher scores indicate increased walking.
Measured: Baseline, 4 months and 8 months
Change in Leisure Time and Physical Activity
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them if they get about 30 minutes of leisure time/recreational physical activity or exercise every day. Answers will include: 0= No, and I do not intend to in the next 6 months, 1=No, but I intend to in the next 6 months, 2=No, but I intend to in the next 30 days, 3=Yes, I have been but for less than 6 months, and 4=Yes I have been for the past 6 months. Data will be presented as the average intention to get 30 minutes of exercise every day compared between groups over time. Scores range from 0-4; higher scores indicate increased activity.
Measured: Baseline, 4 months and 8 months
Change in General Health
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them to state if they consider their health to be: 0=poor, 1=fair, 2=good, 3=very good, or 4=excellent. Data will be presented as the average ranking of individual health compared between groups over time. Scores range from 0-4; higher scores indicate a higher perception of health.
Measured: Baseline, 4 months and 8 months
Change in Participation in Program
Participants will complete a survey at baseline, 4 months, and 8 months that will ask them why they decided to participate in the program. Data will be presented as the number of participants that selected the most frequent answer ("to receive a farmer's market voucher").
Measured: Baseline, 4 months and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start15 May 2018
- Primary completion21 May 2019
- Study completion21 May 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be compared between walking and non-walking groups to assess dietary behavior.
- Masking
- None (open label)
- Enrolment
- 157 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
- NCT03567252
- Sponsor's protocol ID
- 44215
- Other IDs
- P42ES007380
- Status last verified
- Jul 2021
- First submitted
- 23 May 2018
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It depends on the quality of data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tanglewood to Table: A Walking Farmer's Market Group and Control
- ClinicalTrials.gov ID
- NCT03567252
- Acronym / sponsor ID
- 44215
- Conditions
- Dietary Habits
- Keywords
- Appalachia, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Dawn BrewerUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 15 May 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Posted 23 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This program encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Thursday or Saturday. The study aims to determine if walking to the market to receive vouchers improve health outcomes beyond controls who receive nutrition education.
Detailed description
In the summer of 2018, community members of Whitesburg, Kentucky (KY) were recruited to join the Tanglewood to Table walking program, and community members of Harlan, KY were invited to serve as controls. Each Thursday or Saturday, participants report whether or not they walked the 1 mile trail to the farmers market, how many steps the walked in the previous 7 days and they reported which fruits and vegetables they consumed the previous week. The control group will receive nutrition education handouts. The program is from June 2018 - January 2019. Participants complete questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. Recruiting for the 2018 Walking Program will begin in May.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be compared between walking and non-walking groups to assess dietary behavior.
| Arm | Type | Receives |
|---|---|---|
| Walking Group | Experimental | Behavioral: Walking GroupParticipants in this group will join an established walking group and travel by foot 1 kilometer to a local Farmer's Market. They will also receive handouts about nutrition information and nutritional choices. |
| Non-Walking Group | No intervention | –Participants in this group will have no walking requirement. They will receive handouts about nutrition information and nutritional choices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years
- non-pregnant
- moderate to good health (able to walk approximately 1 mile)
Key exclusion criteria (6 listed)
- under 18 years
- pregnant
- poor health (unable to walk approximately 1 mile)
- institutionalized adults
- impaired consent capacity
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 GroupParticipants will walk 1 kilometer to a Farmer's Market. | Behavioural | Walking Group |
Primary outcome
Fruit Intake
Time frame: Baseline, 4 months and 8 months
Participants will complete a survey indicating the total servings of fruit consumed (possible answers range from 1 serving in 3 months to 3 servings per day). Survey will be measured at baseline, 4 months, and 8 months. Data will be presented as average servings of fruit per group over time.
Vegetable Intake
Time frame: Baseline, 4 months and 8 months
Participants will complete a survey indicating the total servings of vegetables consumed (possible answers range from 1 serving in 3 months to 3 servings per day). Survey will be measured at baseline, 4 months, and 8 months. Data will be presented as average servings of vegetables per group over time.
20 secondary outcomes
Change in Understanding of Plant-based Nutrients
Time frame: Baseline, 4 months and 8 months
Change in Believing in the Benefits of Plant-based Nutrients
Time frame: Baseline, 4 months and 8 months
Change in Believing in the Preventative Effects of Plant-based Nutrients
Time frame: Baseline, 4 months and 8 months
Change in Believing in the Role of a Healthy Diet in Protecting Health From Pollutants
Time frame: Baseline, 4 months and 8 months
Change in Knowledge of Which Foods Contain Phytonutrients
Time frame: Baseline, 4 months and 8 months
Change in Knowledge of Environmental Pollutants
Time frame: Baseline, 4 months and 8 months
Change in Days of Vigorous Exercise in the Last Week
Time frame: Baseline, 4 months and 8 months
Change in Days of Moderate Exercise in the Last Week
Time frame: Baseline, 4 months and 8 months
Change in Time Spent in Vigorous Exercise in the Last Week
Time frame: Baseline, 4 months and 8 months
Change in Time Spent in Moderate Exercise in the Last Week
Time frame: Baseline, 4 months and 8 months
Change in Time Spent Walking
Time frame: Baseline, 4 months and 8 months
Change in Time Spent Sitting
Time frame: Baseline, 4 months and 8 months
Change in Dark Green Vegetable Consumption
Time frame: Baseline, 4 months and 8 months
Change in Red and Orange Vegetable Consumption
Time frame: Baseline, 4 months and 8 months
Change in Fruit and Vegetable Consumption
Time frame: Baseline, 4 months and 8 months
Change in Fruit Consumption
Time frame: Baseline, 4 months and 8 months
Change in Walking 1 Mile Per Day
Time frame: Baseline, 4 months and 8 months
Change in Leisure Time and Physical Activity
Time frame: Baseline, 4 months and 8 months
Change in General Health
Time frame: Baseline, 4 months and 8 months
Change in Participation in Program
Time frame: Baseline, 4 months and 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. It depends on the quality of 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 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 3 inclusion and 6 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 23 Jul 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 23 Jul 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?
Fruit Intake (time frame: Baseline, 4 months and 8 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 23 Jul 2021.