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NCT04207268 | Withdrawn | Cardiovascular Diseases


Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health
Sponsor:

Milton S. Hershey Medical Center

Information provided by (Responsible Party):

Susan Veldheer

Brief 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).

Condition or disease

Cardiovascular Diseases

Intervention/treatment

Gardening and Nutrition Advice

Nutrition Advice

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 0 participants
Masking : Double
Primary Purpose : Treatment
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
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023
Arm Intervention/treatment

Experimental: Gardening and Nutrition Advice

Participate in gardening activities, food demonstrations and nutrition advice

Behavioral: Gardening and Nutrition Advice

Placebo Comparator: Nutrition Advice alone

Participate in only nutrition advice

Behavioral: Nutrition Advice

Ages Eligible for Study: 20 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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
    • High cholesterol
    • High blood pressure
    • Overweight/obesity (BMI >=25)
    • Diabetes
    • Current or past Tobacco use
    Exclusion Criteria
    • 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

Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health

Location Details


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Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health

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Locations


Not yet recruiting

United States, Pennsylvania

Penn State College of Medicine

Hershey, Pennsylvania, United States, 17033

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