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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04237571
Other study ID # 55735
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 23, 2020
Est. completion date May 29, 2020

Study information

Verified date July 2020
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Previous adult participants of the Tanglewood to Table walking program will be recruited to enroll in the CANE Meal Program. This program will encourage participants to pick up a healthy meal from the CANE Kitchen each week for five weeks. The meal will consist of at least one serving of fruit or vegetables. At each meal, educational materials will be distributed, including the recipe for healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included. Surveys, blood pressure, height, weight, waist circumference and carotenoid status will be assessed before and after the program.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 29, 2020
Est. primary completion date May 29, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- over 18 years of age

- previous participant in Tanglewood to Table Walking Program

Exclusion Criteria:

- institutionalized adults

- children under the age of 18

- adults with impaired consent capacity

- incarcerated adults

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CANE Meal Program
Participants will be encouraged to pick up a healthy meal from the Community Agriculture Nutritional Experience (CANE) Kitchen in Whitesburg, Kentucky once a week for five weeks. The meals will consist of at least one serving of a fruit or a vegetable. At each meal, education materials will be distributed, including the recipe for the healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
Dawn Brewer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fruit and vegetable consumption. Fruit and vegetable consumption will be assessed with a food frequency questionnaire pre- and post-intervention. This questionnaire asks participants to estimate the frequency of consumption on a ten point scale (from never to three times per day) of 45 specific fruits or vegetables. Aggregate scores range from 0-450 with higher scores indicating increased consumption. Five weeks
Primary Change in weight. Body weight will be measured on a digital scale pre- and post-intervention. Five weeks
Primary Change in waist circumference Waist circumference will be measured with a tape measure pre- and post-intervention. Five weeks
Primary Change in total blood pressure Systolic and diastolic blood pressure will be measured pre- and post-intervention using a digital blood pressure machine. Five weeks
Primary Change in carotenoid status Carotenoid status will be measured via carotenoid RS scanner, an objective measure of diet-derived pigments in the skin. Five weeks
Primary Change in knowledge of nutrition and environmental pollution. Knowledge of nutrition and environmental pollution will be assessed using a mixed 6-item survey containing 4 "yes" "no" "not sure" questions and two multiple choice knowledge questions. The questionnaire does not have an absolute range, but a higher percent of "not sure" responses indicates less knowledge of nutrition and pollution; while a higher percentage of absolutely correct responses indicates increased knowledge. Data will be reported as the change from pre- to post-intervention. Five weeks
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