Cardiovascular DiseasesNCT04207268
Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health
A study testing Gardening and Nutrition Advice and Nutrition Advice in people with Cardiovascular Diseases, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of group-based nutrition advice plus gardening (intervention) versus group-based nutrition advice alone on dietary intake of fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Gardening and Nutrition Advice and Nutrition Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 31 Oct 2023
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are at least 20 years old
- Have transportation and are willing to travel to the Hershey Community Garden
- Have any two health conditions or risk factors for CVD. These include, but are not limited to:
- Any history of cardiovascular disease
- Any family history of premature cardiovascular disease
- Any history of stroke
Show all 11Show fewer
- High cholesterol
- High blood pressure
- Overweight/obesity (BMI >=25)
- Diabetes
- Current or past Tobacco use
Who cannot join
- Currently tends a vegetable garden
- Moving out of the area in the next 4 months
- Non-English speaking
- Pregnant women
- Participation in a past gardening study
- Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)
- A medical condition that precludes safe pursuit of gardening, i.e., recent heart conditions (e.g., heart failure, stroke, heart attack), recent or pending surgery, severe orthopedic conditions, pending hip/knee replacement, paralysis, dementia, blindness, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or allergies.
- History of difficulty obtaining blood samples or fear of needles
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Dietary Intake of Fruits and Vegetables and Cardiovascular Disease Risk
The purpose of this study is to test the effect of group-based nutrition advice plus gardening (intervention) versus group-based nutrition advice alone on dietary intake of fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD).
Read the detailed description
Study participants will be randomly assigned to attend group sessions related to gardening with nutrition advice or nutrition advice alone. The main goal of the intervention will be to encourage participants to increase their intake of fruits and vegetables.
- Conditions
- Cardiovascular Diseases
- Being tested
- Gardening and Nutrition Advice, Nutrition Advice
- Keywords
- Cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardening and Nutrition AdviceBehavioural
Participate in gardening activities, gardening instructions and nutrition advice
Nutrition AdviceBehavioural
Participate in only nutrition advice
| Study group | Role | What they receive |
|---|---|---|
| Gardening and Nutrition Advice | Experimental | Participate in gardening activities, food demonstrations and nutrition advice Receives: Behavioral: Gardening and Nutrition Advice |
| Nutrition Advice alone | Placebo comparator | Participate in only nutrition advice Receives: Behavioral: Nutrition Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Carotenoids
The primary outcome is between group differences in total plasma carotenoids from baseline to 16 weeks. Plasma carotenoids are a reliable bio-marker of dietary intake of F\&V.
Measured: 4 months
Self-reported dietary intake
Investigators will also test the between group differences in self-reported servings of fruits and vegetables as assessed by 24-hour recalls.
Measured: 4 months
Secondary outcomes (2)
Cardiovascular disease risk score
Differences in Cardiovascular Disease (CVD) risk score based on the American College of Cardiology/American Heart Association (ACC/AHA) lifetime CVD risk score calculation (risk score range 0-100%). Higher scores indicate greater risk of a lifetime CVD-related event.
Measured: 4 months
Physical activity
Between group differences in minutes of physical activity as measured by the International Physical Activity Questionnaire (IPAQ), (range in minutes, 0-3000+). Higher scores indicate more physical activity.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start19 Dec 2019
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Why it stopped: Protocol could not be initiated due to COVID.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Veldheer, Milton S. Hershey Medical Center
- Investigators
- Susan Veldheer, DEd, RD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207268
- Sponsor's protocol ID
- STUDY00013976
- Status last verified
- Jun 2022
- First submitted
- 18 Dec 2019
- Last updated
- 22 Jun 2022
- Results posted
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Dietary Intake of Fruits and Vegetables and Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT04207268
- Acronym / sponsor ID
- STUDY00013976
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol could not be initiated due to COVID.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 20 Dec 2019 (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.
The purpose of this study is to test the effect of group-based nutrition advice plus gardening (intervention) versus group-based nutrition advice alone on dietary intake of fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD).
Detailed description
Study participants will be randomly assigned to attend group sessions related to gardening with nutrition advice or nutrition advice alone. The main goal of the intervention will be to encourage participants to increase their intake of fruits and vegetables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gardening and Nutrition Advice | Experimental | Behavioral: Gardening and Nutrition AdviceParticipate in gardening activities, food demonstrations and nutrition advice |
| Nutrition Advice alone | Placebo comparator | Behavioral: Nutrition AdviceParticipate in only nutrition advice |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Are at least 20 years old
- Have transportation and are willing to travel to the Hershey Community Garden
- Have any two health conditions or risk factors for CVD. These include, but are not limited to:
Key exclusion criteria (8 listed)
- Currently tends a vegetable garden
- Moving out of the area in the next 4 months
- Non-English speaking
- Pregnant women
- Participation in a past gardening study
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 |
|---|---|---|
| Gardening and Nutrition AdviceParticipate in gardening activities, gardening instructions and nutrition advice | Behavioural | Gardening and Nutrition Advice |
| Nutrition AdviceParticipate in only nutrition advice | Behavioural | Nutrition Advice alone |
Primary outcome
Plasma Carotenoids
Time frame: 4 months
The primary outcome is between group differences in total plasma carotenoids from baseline to 16 weeks. Plasma carotenoids are a reliable bio-marker of dietary intake of F\&V.
Self-reported dietary intake
Time frame: 4 months
Investigators will also test the between group differences in self-reported servings of fruits and vegetables as assessed by 24-hour recalls.
2 secondary outcomes
Cardiovascular disease risk score
Time frame: 4 months
Physical activity
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- 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.
Susan Veldheer, DEd, RD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gardening and Nutrition Advice and Nutrition Advice in people with Cardiovascular Diseases, run by Milton S. Hershey Medical Center 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 11 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 Jun 2022. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Plasma Carotenoids (time frame: 4 months). The study lists 2 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 22 Jun 2022.