Clinical trial NCT05720611: Growing Healthy Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease
Official title: Growing Health Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Are at least 20 years old
2. Have any one or more health condition(s) or risk factor(s) for CVD. These include, but are not limited to:

   1. Any history of cardiovascular disease
   2. 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)
   3. Any history of stroke or DVT
   4. High cholesterol
   5. High blood pressure
   6. Overweight/obesity (BMI \>=25)
   7. Diabetes, prediabetes, or borderline diabetes
   8. Current or past Tobacco use
3. Reports consuming fruit and vegetables less than 5 times per day
4. Report less than 150 minutes of physical activity per week
5. Have access to stable and consistent internet access
6. Have a Facebook account or willing to open a Facebook account
7. Have a smart phone or computer and capacity to download the Fitbit app or Fitbit Connect Software
8. Must be willing to wear a Fitbit tracker almost continually (23.5 hours/day) for duration of study
9. Have access to a kitchen in or near their living space
10. 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:

1. Unwilling to participate in Zoom sessions and have their voice and face recorded for research purposes.
2. 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)
3. Moving out of the area in the next 5 months
4. Non-English speaking or reading
5. Pregnant women
6. Participation in a past FCM gardening intervention study
7. Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)
8. 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.
9. Close contacts of current participants in the study

Primary outcomes:
measure: Acceptability
timeFrame: 24 weeks
Secondary outcomes:
measure: Demand
timeFrame: Baseline and 24 weeks
measure: Practicality
timeFrame: 24 weeks
measure: Fruit and vegetable intake
timeFrame: From baseline to 24 weeks
measure: Physical activity
timeFrame: From baseline to 24 weeks
measure: Cooking confidence
timeFrame: From baseline to 24 weeks
measure: Gardening confidence
timeFrame: From baseline to 24 weeks
measure: Gardening enjoyment
timeFrame: From baseline to 24 weeks
measure: Social support-Healthy eating
timeFrame: From baseline to 24 weeks
measure: Social support-physical activity
timeFrame: From baseline to 24 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
References: