- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05720611
Growing Healthy Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease
November 14, 2024 updated by: Susan Veldheer, Milton S. Hershey Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- 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 Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Health Milton S. Hershey Medical 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
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
- 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)
Exclusion Criteria:
- 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
- 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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention group
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.
|
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.
|
|
Placebo Comparator: Control Group
Participants in this group will complete all questionnaires but will not receive the digitally delivered course or access to Facebook.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demand
Time Frame: Baseline and 24 weeks
|
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
|
Baseline and 24 weeks
|
|
Practicality
Time Frame: 24 weeks
|
80% of intervention group participants report completing 16 out of 20 gardening-related study tasks.
|
24 weeks
|
|
Fruit and vegetable intake
Time Frame: From baseline to 24 weeks
|
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
|
From baseline to 24 weeks
|
|
Physical activity
Time Frame: From baseline to 24 weeks
|
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.
|
From baseline to 24 weeks
|
|
Cooking confidence
Time Frame: From baseline to 24 weeks
|
Between group differences in self-reported cooking confidence score as assessed by the Cooking and Food Skills (Lavelle et al. 2017)
|
From baseline to 24 weeks
|
|
Gardening confidence
Time Frame: From baseline to 24 weeks
|
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.
|
From baseline to 24 weeks
|
|
Gardening enjoyment
Time Frame: From baseline to 24 weeks
|
Between group differences in the total intrinsic motivation score for gardening activity as measured by the Intrinsic Motivations Questionnaire.
|
From baseline to 24 weeks
|
|
Social support-Healthy eating
Time Frame: From baseline to 24 weeks
|
Between group differences the self-reported Social Support for Healthy Eating Questionnaire (Salis et al., 1987).
|
From baseline to 24 weeks
|
|
Social support-physical activity
Time Frame: From baseline to 24 weeks
|
Between group differences in the self-reported Social Support for Physical Activity Questionnaire (Salis et al, 1987)
|
From baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 27, 2023
Primary Completion (Actual)
September 25, 2023
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
January 13, 2023
First Submitted That Met QC Criteria
January 31, 2023
First Posted (Actual)
February 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 18, 2024
Last Update Submitted That Met QC Criteria
November 14, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00017020
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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