- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04237571
Community Agriculture Nutritional Enterprises (CANE) Meal Program
July 21, 2020 updated by: Dawn Brewer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CANE Adult Participants
This sample population consists of an active intervention group of prior Tanglewood to Table walking program adult participants.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fruit and vegetable consumption.
Time Frame: Five weeks
|
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.
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Five weeks
|
Change in weight.
Time Frame: Five weeks
|
Body weight will be measured on a digital scale pre- and post-intervention.
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Five weeks
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Change in waist circumference
Time Frame: Five weeks
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Waist circumference will be measured with a tape measure pre- and post-intervention.
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Five weeks
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Change in total blood pressure
Time Frame: Five weeks
|
Systolic and diastolic blood pressure will be measured pre- and post-intervention using a digital blood pressure machine.
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Five weeks
|
Change in carotenoid status
Time Frame: Five weeks
|
Carotenoid status will be measured via carotenoid RS scanner, an objective measure of diet-derived pigments in the skin.
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Five weeks
|
Change in knowledge of nutrition and environmental pollution.
Time Frame: Five weeks
|
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.
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Five weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dawn Brewer, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2020
Primary Completion (Actual)
May 29, 2020
Study Completion (Actual)
May 29, 2020
Study Registration Dates
First Submitted
January 17, 2020
First Submitted That Met QC Criteria
January 17, 2020
First Posted (Actual)
January 23, 2020
Study Record Updates
Last Update Posted (Actual)
July 23, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 55735
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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