Diet, HealthyNCT04237571
Community Agriculture Nutritional Enterprises (CANE) Meal Program
A study testing CANE Meal Program in people with Diet, Healthy and Life Style, Healthy, run by Dawn Brewer at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Life Style, Healthy
- What is being tested?
- CANE Meal Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2020to 29 May 2020
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years of age
- previous participant in Tanglewood to Table Walking Program
Who cannot join
- institutionalized adults
- children under the age of 18
- adults with impaired consent capacity
- incarcerated adults
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diet, Healthy, Life Style, Healthy
- Being tested
- CANE Meal Program
- Keywords
- fruits, vegetables, exercise, community, education
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CANE Meal ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CANE Adult Participants | Experimental | This sample population consists of an active intervention group of prior Tanglewood to Table walking program adult participants. Receives: Behavioral: CANE Meal Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five weeks
Change in weight.
Body weight will be measured on a digital scale pre- and post-intervention.
Measured: Five weeks
Change in waist circumference
Waist circumference will be measured with a tape measure pre- and post-intervention.
Measured: Five weeks
Change in total blood pressure
Systolic and diastolic blood pressure will be measured pre- and post-intervention using a digital blood pressure machine.
Measured: Five weeks
Change in carotenoid status
Carotenoid status will be measured via carotenoid RS scanner, an objective measure of diet-derived pigments in the skin.
Measured: Five weeks
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.
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start23 Jan 2020
- Primary completion29 May 2020
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dawn Brewer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dawn Brewer, University of Kentucky
- Investigators
- Dawn Brewer, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237571
- Sponsor's protocol ID
- 55735
- Status last verified
- Jul 2020
- First submitted
- 17 Jan 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Agriculture Nutritional Enterprises (CANE) Meal Program
- ClinicalTrials.gov ID
- NCT04237571
- Acronym / sponsor ID
- 55735
- Conditions
- Diet, Healthy, Life Style, Healthy
- Keywords
- fruits, vegetables, exercise, community, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dawn BrewerUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 23 Jan 2020 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CANE Adult Participants | Experimental | Behavioral: CANE Meal ProgramThis sample population consists of an active intervention group of prior Tanglewood to Table walking program adult participants. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- previous participant in Tanglewood to Table Walking Program
Key exclusion criteria (4 listed)
- institutionalized adults
- children under the age of 18
- adults with impaired consent capacity
- incarcerated adults
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 |
|---|---|---|
| CANE Meal ProgramParticipants 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. | Behavioural | CANE Adult Participants |
Primary outcome
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.
Change in weight.
Time frame: Five weeks
Body weight will be measured on a digital scale pre- and post-intervention.
Change in waist circumference
Time frame: Five weeks
Waist circumference will be measured with a tape measure pre- and post-intervention.
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.
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.
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.
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 23 Jul 2020.
- Individual participant dataSharing planned: No
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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 principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CANE Meal Program in people with Diet, Healthy and Life Style, Healthy, run by Dawn Brewer at 1 site 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 2 inclusion and 4 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 fruit and vegetable consumption. (time frame: Five weeks). The study lists 6 primary outcomes in all. 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 23 Jul 2020.