An interventional study of walking group led by a community organizer in Dietary Habits, sponsored by Dawn Brewer. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-17.
Sponsored by Dawn Brewer · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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.
Behavioral: walking group led by a community organizer
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.
Behavioral: 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 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.
Time frame: Baseline and 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 3 months
Change in Self-reported Fruit and Vegetable Intake
Subjects' self-reported total servings of fruit and vegetable intake per day.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
123 participants were enrolled, but two participants dropped out of the study within the first month due to lack of interest.
| Milestone | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Started | 60 | 61 |
| Completed | 60 | 61 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
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.
| percent change | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Change in A1c | -0.31 ± 0.53 | -0.20 ± 0.52 |
Subjects' LDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant LDL.
| mg/dL | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Change in LDL Cholesterol | -11.9 ± 23.8 | -12.7 ± 17.5 |
Subjects' HDL will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant HDL.
| mg/dL | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Males | 1.6 ± 4.3 | 8.8 ± 7.2 |
| Females | 0.04 ± 8.5 | 5.3 ± 10.0 |
Subjects' total cholesterol will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant total cholesterol.
| mg/dL | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Change in Total Cholesterol | -14.8 ± 32.5 | -11.0 ± 24.2 |
Subjects' weight will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant weight.
| lb | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Change in Weight | 0.23 ± 5.4 | -1.4 ± 11.8 |
Subjects' waist circumference will be measured to determine if walking combined with a voucher for fruits and vegetables changes participant waist circumference.
| inches | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Male | -0.30 ± 1.3 | -0.34 ± 2.1 |
| Female | -0.33 ± 2.3 | -0.88 ± 3.8 |
Subjects' self-reported activity level will be measured as self-reported days of leisure physical activity per week.
| days of physical activity per week | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Change in Self-reported Activity Level | 1.7 ± 2.6 | 1.4 ± 2.1 |
Subjects' self-reported total servings of fruit and vegetable intake per day.
| servings of fruit and vegetables per day | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Change in Self-reported Fruit and Vegetable Intake | 1.0 ± 4.2 | 2.4 ± 2.7 |
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.
| score on a scale | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| Group Cohesion | 130.2 ± 53.1 | 155.3 ± 40.7 |
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.
| Participants | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| baseline | 11 | 17 |
| 3 months | 12 | 20 |
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.
| Participants | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| baseline | 7 | 12 |
| 3 months | 5 | 19 |
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.
| Participants | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| baseline | 8 | 11 |
| 3 months | 11 | 18 |
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.
| Participants | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| baseline | 6 | 9 |
| 3 months | 9 | 15 |
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.
| Participants | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| baseline | 17 | 17 |
| 3 months | 13 | 27 |
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.
| Participants | Walking Group (Low Engagers) | Walking Group (High Engagers) |
|---|---|---|
| baseline | 13 | 22 |
| 3 months | 8 | 15 |
Collected over Adverse event data were not collected during the course of this study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Walking Group (Low Engagers) | — | — | — |
| Walking Group (High Engagers) | — | — | — |
| Age, Continuous(years) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| Mean | 53.9 ± 14.7 | 46.7 ± 14.7 | 50.2 ± 15.0 |
| Sex: Female, Male(Participants) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| Female | 35 | 37 | 72 |
| Male | 25 | 24 | 49 |
| Ethnicity (NIH/OMB)(Participants) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 58 | 58 | 116 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 57 | 59 | 116 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| United States | 60 | 61 | 121 |
| Body Mass Index (BMI)(kg/m^2) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| Mean | 33.4 ± 7.3 | 33.4 ± 7.0 | 33.4 ± 7.1 |
| Diastolic Blood Pressure(mmHg) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| Mean | 80.6 ± 9.3 | 84.3 ± 10.8 | 82.5 ± 10.2 |
| Systolic Blood Pressure(mmHg) | Walking Group (Low Engagers) | Walking Group (High Engagers) | Total |
|---|---|---|---|
| Mean | 128.4 ± 15.7 | 129.1 ± 18.0 | 128.8 ± 16.9 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No current plan to share data.
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Dawn Brewer