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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Blackberry Consumption
Measures of biomedical and behavioral changes resulting from the consumption of blackberries.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dawn Brewer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Environmental Health Sciences (NIEHS)

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2018

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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