Cardiovascular DiseasesNCT05720611
Growing Healthy Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease
A study testing Digitally delivered gardening and healthy eating course in people with Cardiovascular Diseases, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study aims to assess the effectiveness on an online gardening study for beginner gardeners with the goal of improving diet and physical activity in those with at least one risk factor for cardiovascular disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Digitally delivered gardening and healthy eating course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2023to 1 Aug 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 20 years old
- Have any one or more health condition(s) or risk factor(s) for CVD. These include, but are not limited to:
- Any history of cardiovascular disease
- Any family history of cardiovascular disease (as measured by asking if both living and deceased, close biological relatives, that is, blood relatives including father, mother, sisters or brothers, ever told by a health professional that they had a heart attack or angina before the age of 50)
- Any history of stroke or DVT
- High cholesterol
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- High blood pressure
- Overweight/obesity (BMI >=25)
- Diabetes, prediabetes, or borderline diabetes
- Current or past Tobacco use
- Reports consuming fruit and vegetables less than 5 times per day
- Report less than 150 minutes of physical activity per week
- Have access to stable and consistent internet access
- Have a Facebook account or willing to open a Facebook account
- Have a smart phone or computer and capacity to download the Fitbit app or Fitbit Connect Software
- Must be willing to wear a Fitbit tracker almost continually (23.5 hours/day) for duration of study
- Have access to a kitchen in or near their living space
- Has access to space to start a garden (at home or in a community garden either in the ground, raised beds, or containers)
Who cannot join
- Unwilling to participate in Zoom sessions and have their voice and face recorded for research purposes.
- Currently tends a vegetable garden (as measured by if they have tended a garden in the past year or are planning to tend a garden (outside of this study) in the coming season)
- Moving out of the area in the next 5 months
- Non-English speaking or reading
- Pregnant women
- Participation in a past FCM gardening intervention study
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- 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, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or allergies.
- Close contacts of current participants in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Growing Health Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease
This study aims to assess the effectiveness on an online gardening study for beginner gardeners with the goal of improving diet and physical activity in those with at least one risk factor for cardiovascular disease.
Read the detailed description
The purpose of this study is to test the feasibility of an online gardening and nutrition intervention in adults with risk factors for cardiovascular disease using a randomized controlled trial design. During the trial, the intervention condition will learn how to start a garden plot (either at home or in a community garden) and grow fruits and vegetables for personal consumption. We will also provide this group with nutrition education related to the DASH diet and basic cooking skills instruction. The control condition participants will receive no intervention during the study period.
- Conditions
- Cardiovascular Diseases
- Being tested
- Digitally delivered gardening and healthy eating course
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally delivered gardening and healthy eating courseBehavioural
The intervention group will consist of a digitally delivered course designed to teach gardening, cooking and nutrition education to adults with risk factors for CVD. Participants will be invited to participate in 10 Zoom-based gardening and cooking education sessions. Zoom meetings will be facilitated by members of the study team, will present information to participants and will allow participants to ask questions and share their experiences with others. The materials will walk the participant through various aspects of starting and tending a garden.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | The intervention group will consist of a digitally delivered course designed to teach gardening, cooking and nutrition education to adults with risk factors for CVD. Participants will be invited to participate in 10 Zoom-based gardening and cooking education sessions. Zoom meetings will be facilitated by members of the study team, will present information to participants and will allow participants to ask questions and share their experiences with others. The materials will walk the participant through various aspects of starting and tending a garden. Participants will be asked to engage in a closed Facebook group. Receives: Behavioral: Digitally delivered gardening and healthy eating course |
| Control Group | Placebo comparator | Participants in this group will complete all questionnaires but will not receive the digitally delivered course or access to Facebook. Receives: Behavioral: Digitally delivered gardening and healthy eating course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Participant acceptability of the program based on 80% of intervention participants providing an average rating of the intervention as 4 or higher on the Weiner Acceptability Scale
Measured: 24 weeks
Secondary outcomes (9)
Demand
Participant demand in terms of 1) ability to recruit 40 participants at baseline and 2) ability to retain at least 70% of participants as measured by number of participants who complete the follow up questionnaires at the 24 week time point
Measured: Baseline and 24 weeks
Practicality
80% of intervention group participants report completing 16 out of 20 gardening-related study tasks.
Measured: 24 weeks
Fruit and vegetable intake
Between group differences in servings of fruits and vegetables from baseline to 24 weeks as assessed by the National Cancer Institute's Diet History Questionnaire 3
Measured: From baseline to 24 weeks
Physical activity
Between group differences in minutes of self-reported physical activity from baseline to 24 weeks as assessed by the International Physical Activity Questionnaire short form.
Measured: From baseline to 24 weeks
Cooking confidence
Between group differences in self-reported cooking confidence score as assessed by the Cooking and Food Skills (Lavelle et al. 2017)
Measured: From baseline to 24 weeks
Gardening confidence
Between group differences in total gardening confidence score as assessed by a 20 item gardening task questionnaire on confidence to complete gardening tasks using a 10 point Likert scale.
Measured: From baseline to 24 weeks
Gardening enjoyment
Between group differences in the total intrinsic motivation score for gardening activity as measured by the Intrinsic Motivations Questionnaire.
Measured: From baseline to 24 weeks
Social support-Healthy eating
Between group differences the self-reported Social Support for Healthy Eating Questionnaire (Salis et al., 1987).
Measured: From baseline to 24 weeks
Social support-physical activity
Between group differences in the self-reported Social Support for Physical Activity Questionnaire (Salis et al, 1987)
Measured: From baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start27 Jan 2023
- Primary completion25 Sep 2023
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720611
- Sponsor's protocol ID
- STUDY00017020
- Status last verified
- Nov 2024
- First submitted
- 13 Jan 2023
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Veldheer S, Rutt K, Schaefer E, Kim I, Hrabovsky S, Smith B, Thomas OW, Moore AM, Pagoto S, Conroy DE, Schmitz KH, Sciamanna C. Growing Healthy Hearts: a pilot randomized controlled trial of a digitally delivered gardening, cooking, and Dietary Approaches to Stop Hypertension (DASH) diet intervention for adults with cardiovascular risk factors. Pilot Feasibility Stud. 2026 Jan 28;12(1):30. doi: 10.1186/s40814-026-01766-1.
PubMed 41606653
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Health Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05720611
- Acronym / sponsor ID
- STUDY00017020
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 9 Feb 2023 (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.
This study aims to assess the effectiveness on an online gardening study for beginner gardeners with the goal of improving diet and physical activity in those with at least one risk factor for cardiovascular disease.
Detailed description
The purpose of this study is to test the feasibility of an online gardening and nutrition intervention in adults with risk factors for cardiovascular disease using a randomized controlled trial design. During the trial, the intervention condition will learn how to start a garden plot (either at home or in a community garden) and grow fruits and vegetables for personal consumption. We will also provide this group with nutrition education related to the DASH diet and basic cooking skills instruction. The control condition participants will receive no intervention during the study period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Digitally delivered gardening and healthy eating courseThe intervention group will consist of a digitally delivered course designed to teach gardening, cooking and nutrition education to adults with risk factors for CVD. Participants will be invited to participate in 10 Zoom-based gardening and cooking education sessions. Zoom meetings will be facilitated by members of the study team, will present information to participants and will allow participants to ask questions and share their experiences with others. The materials will walk the participant through various aspects of starting and tending a garden. Participants will be asked to engage in a closed Facebook group. |
| Control Group | Placebo comparator | Behavioral: Digitally delivered gardening and healthy eating courseParticipants in this group will complete all questionnaires but will not receive the digitally delivered course or access to Facebook. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Are at least 20 years old
- Have any one or more health condition(s) or risk factor(s) for CVD. These include, but are not limited to:
- Reports consuming fruit and vegetables less than 5 times per day
- Report less than 150 minutes of physical activity per week
- Have access to stable and consistent internet access
Key exclusion criteria (9 listed)
- Unwilling to participate in Zoom sessions and have their voice and face recorded for research purposes.
- Currently tends a vegetable garden (as measured by if they have tended a garden in the past year or are planning to tend a garden (outside of this study) in the coming season)
- Moving out of the area in the next 5 months
- Non-English speaking or reading
- Pregnant women
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 |
|---|---|---|
| Digitally delivered gardening and healthy eating courseThe intervention group will consist of a digitally delivered course designed to teach gardening, cooking and nutrition education to adults with risk factors for CVD. Participants will be invited to participate in 10 Zoom-based gardening and cooking education sessions. Zoom meetings will be facilitated by members of the study team, will present information to participants and will allow participants to ask questions and share their experiences with others. The materials will walk the participant through various aspects of starting and tending a garden. | Behavioural | Control Group, Intervention group |
Primary outcome
Acceptability
Time frame: 24 weeks
Participant acceptability of the program based on 80% of intervention participants providing an average rating of the intervention as 4 or higher on the Weiner Acceptability Scale
9 secondary outcomes
Demand
Time frame: Baseline and 24 weeks
Practicality
Time frame: 24 weeks
Fruit and vegetable intake
Time frame: From baseline to 24 weeks
Physical activity
Time frame: From baseline to 24 weeks
Cooking confidence
Time frame: From baseline to 24 weeks
Gardening confidence
Time frame: From baseline to 24 weeks
Gardening enjoyment
Time frame: From baseline to 24 weeks
Social support-Healthy eating
Time frame: From baseline to 24 weeks
Social support-physical activity
Time frame: From baseline to 24 weeks
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 18 Nov 2024.
- Derived from this study: PubMed 41606653Veldheer S, Rutt K, Schaefer E, Kim I, Hrabovsky S, Smith B, Thomas OW, Moore AM, Pagoto S, Conroy DE, Schmitz KH, Sciamanna C. Growing Healthy Hearts: a pilot randomized controlled trial of a digitally delivered gardening, cooking, and Dietary Approaches to Stop Hypertension (DASH) diet intervention for adults with cardiovascular risk factors. Pilot Feasibility Stud. 2026 Jan 28;12(1):30. doi: 10.1186/s40814-026-01766-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitally delivered gardening and healthy eating course 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 18 inclusion and 9 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 18 Nov 2024. 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 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?
Acceptability (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05720611, which also lists 1 linked publication.
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 18 Nov 2024.