- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477305
BerryCare: A Community Engagement Program
January 18, 2023 updated by: Dawn Brewer
BerryCare: A Blackberry Extension Lesson Series to Facilitate Community Engagement and Phytonutrient Intake
BerryCare teaches people about the health benefits of blackberries, how to harvest and maintain blackberry bushes and then assesses changes in knowledge and behaviors associated with blackberries and physical measurements.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
BerryCare seeks to teach community members how to grow thornless, erect blackberry brambles and to healthily consume fresh blackberries using Plate It Up Kentucky Proud recipes.
Horticulture, nutrition, and extension experts are working together to design a blackberry-growing program that engages citizens and their community in each step of the process, from planting to harvesting berries.
The lessons will be delivered by experts in their respective field, with accompanying extension publications and supplemental materials provided for replication of the curriculum in other counties.
Study Type
Interventional
Enrollment (Actual)
38
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
-
-
Kentucky
-
Beverly, Kentucky, United States, 40913
- Red Bird Mission
-
Harlan, Kentucky, United States, 40831
- Harlan County Extension Office
-
Lexington, Kentucky, United States, 40506
- University Of Kentucky
-
Nicholasville, Kentucky, United States, 40356
- Jessamine County Senior Citizens Center
-
Whitesburg, Kentucky, United States, 41858
- Cowan Community Center
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older
Exclusion Criteria:
- Physically incapacitated
- Mentally incapacitated
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BerryCare Participants
Subjects will be recruited to participate in a community gardening program where they will learn the benefits of both physical active gardening and consuming homegrown foods through blackberry consumption.
|
Measures of biomedical and behavioral changes resulting from the consumption of blackberries.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in consumption of blackberries
Time Frame: Baseline, 6 months, 12 months, 18 months
|
Blackberry consumption will be measured in participants during pre screening and throughout the course of the study.
|
Baseline, 6 months, 12 months, 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood pressure
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on blood pressure will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in total cholesterol
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on total cholesterol will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in HDL cholesterol
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on HDL cholesterol will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in LDL cholesterol
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on LDL cholesterol will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in A1c
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on A1c will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in carotenoids
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on carotenoid status will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in weight
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on weight will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in waist circumference
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on waist circumference will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in knowledge
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on knowledge of phytonutrients and recommended servings of fruits and vegetables will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in self-reported fruit and vegetable intake
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on self-reported fruit and vegetable intake will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in group cohesion
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on group cohesion will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
|
Change in physical function
Time Frame: Baseline, 6 months, 12 months, 18 months
|
The effect of blackberry consumption on physical function will be assessed at baseline and throughout the study.
|
Baseline, 6 months, 12 months, 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 18, 2017
Primary Completion (Actual)
September 26, 2018
Study Completion (Actual)
September 26, 2018
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (Actual)
March 26, 2018
Study Record Updates
Last Update Posted (Estimate)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 18, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 43452
- P42ES007380 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No plan to share data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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