Cardiovascular Risk FactorNCT03477305
BerryCare: A Community Engagement Program
A study testing Blackberry Consumption in people with Cardiovascular Risk Factor, run by Dawn Brewer at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Blackberry Consumption
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jan 2017to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
Who cannot join
- Physically incapacitated
- Mentally incapacitated
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Red Bird Mission
Beverly, Kentucky, 40913
Harlan County Extension Office
Harlan, Kentucky, 40831
University of Kentucky
Lexington, Kentucky, 40506
Jessamine County Senior Citizens Center
Nicholasville, Kentucky, 40356
Cowan Community Center
Whitesburg, Kentucky, 41858
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Blackberry Consumption
- Keywords
- older adults, community gardening, cooperative extension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blackberry ConsumptionBehavioural
Measures of biomedical and behavioral changes resulting from the consumption of blackberries.
| Study group | Role | What they receive |
|---|---|---|
| BerryCare Participants | Experimental | 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. Receives: Behavioral: Blackberry Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in consumption of blackberries
Blackberry consumption will be measured in participants during pre screening and throughout the course of the study.
Measured: Baseline, 6 months, 12 months, 18 months
Secondary outcomes (12)
Change in blood pressure
The effect of blackberry consumption on blood pressure will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in total cholesterol
The effect of blackberry consumption on total cholesterol will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in HDL cholesterol
The effect of blackberry consumption on HDL cholesterol will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in LDL cholesterol
The effect of blackberry consumption on LDL cholesterol will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in A1c
The effect of blackberry consumption on A1c will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in carotenoids
The effect of blackberry consumption on carotenoid status will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in weight
The effect of blackberry consumption on weight will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in waist circumference
The effect of blackberry consumption on waist circumference will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in knowledge
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.
Measured: Baseline, 6 months, 12 months, 18 months
Change in self-reported fruit and vegetable intake
The effect of blackberry consumption on self-reported fruit and vegetable intake will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in group cohesion
The effect of blackberry consumption on group cohesion will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Change in physical function
The effect of blackberry consumption on physical function will be assessed at baseline and throughout the study.
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start18 Jan 2017
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dawn Brewer
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor-investigator, Dawn Brewer, University of Kentucky
- Investigators
- Dawn Brewer, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477305
- Sponsor's protocol ID
- 43452
- Other IDs
- P42ES007380
- Status last verified
- Jan 2023
- First submitted
- 19 Mar 2018
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BerryCare: A Blackberry Extension Lesson Series to Facilitate Community Engagement and Phytonutrient Intake
- ClinicalTrials.gov ID
- NCT03477305
- Acronym / sponsor ID
- 43452
- Conditions
- Cardiovascular Risk Factor
- Keywords
- older adults, community gardening, cooperative extension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dawn BrewerUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BerryCare Participants | Experimental | Behavioral: Blackberry ConsumptionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older
Key exclusion criteria (2 listed)
- Physically incapacitated
- Mentally incapacitated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blackberry ConsumptionMeasures of biomedical and behavioral changes resulting from the consumption of blackberries. | Behavioural | BerryCare Participants |
Primary outcome
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.
12 secondary outcomes
Change in blood pressure
Time frame: Baseline, 6 months, 12 months, 18 months
Change in total cholesterol
Time frame: Baseline, 6 months, 12 months, 18 months
Change in HDL cholesterol
Time frame: Baseline, 6 months, 12 months, 18 months
Change in LDL cholesterol
Time frame: Baseline, 6 months, 12 months, 18 months
Change in A1c
Time frame: Baseline, 6 months, 12 months, 18 months
Change in carotenoids
Time frame: Baseline, 6 months, 12 months, 18 months
Change in weight
Time frame: Baseline, 6 months, 12 months, 18 months
Change in waist circumference
Time frame: Baseline, 6 months, 12 months, 18 months
Change in knowledge
Time frame: Baseline, 6 months, 12 months, 18 months
Change in self-reported fruit and vegetable intake
Time frame: Baseline, 6 months, 12 months, 18 months
Change in group cohesion
Time frame: Baseline, 6 months, 12 months, 18 months
Change in physical function
Time frame: Baseline, 6 months, 12 months, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No. No plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Brewer, PhD principal investigator
University of Kentucky
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blackberry Consumption in people with Cardiovascular Risk Factor, run by Dawn Brewer at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in consumption of blackberries (time frame: Baseline, 6 months, 12 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.