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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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ClinicalTrials.gov Identifier: NCT04207268
Recruitment Status : Not yet recruiting
First Posted : December 20, 2019
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Susan Veldheer, Milton S. Hershey Medical Center

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 Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Gardening and Nutrition Advice Behavioral: Nutrition Advice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
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
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
Experimental: Gardening and Nutrition Advice
Participate in gardening activities, food demonstrations and nutrition advice
Behavioral: Gardening and Nutrition Advice
Participate in gardening activities, gardening instructions and nutrition advice

Placebo Comparator: Nutrition Advice alone
Participate in only nutrition advice
Behavioral: Nutrition Advice
Participate in only nutrition advice




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Cardiovascular disease risk score [ Time Frame: 4 months ]
    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.

  2. Physical activity [ Time Frame: 4 months ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Are at least 20 years old
  2. Have transportation and are willing to travel to the Hershey Community Garden
  3. Have any two health conditions or risk factors for CVD. These include, but are not limited to:

    1. Any history of cardiovascular disease
    2. Any family history of premature cardiovascular disease
    3. Any history of stroke
    4. High cholesterol
    5. High blood pressure
    6. Overweight/obesity (BMI >=25)
    7. Diabetes
    8. Current or past Tobacco use

Exclusion Criteria:

  1. Currently tends a vegetable garden
  2. Moving out of the area in the next 4 months
  3. Non-English speaking
  4. Pregnant women
  5. Participation in a past gardening study
  6. Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)
  7. 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.
  8. History of difficulty obtaining blood samples or fear of needles

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207268


Contacts
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Contact: Susan Veldheer, DEd 717-531-5625 sveldheer@psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Susan Veldheer, DEd, RD Penn State College of Medicine
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Responsible Party: Susan Veldheer, Assistant Professor, Department of Family and Community Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT04207268    
Other Study ID Numbers: STUDY00013976
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Susan Veldheer, Milton S. Hershey Medical Center:
Cardiovascular disease
Additional relevant MeSH terms:
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Cardiovascular Diseases