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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04207268
• Other study ID #: STUDY00013976
• Status: Withdrawn
• Phase: N/A
• Start date: December 19, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: June 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Gardening and Nutrition Advice
Participate in gardening activities, gardening instructions and nutrition advice
• Nutrition Advice
Participate in only nutrition advice

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Carotenoids	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.	4 months
Primary	Self-reported dietary intake	Investigators will also test the between group differences in self-reported servings of fruits and vegetables as assessed by 24-hour recalls.	4 months
Secondary	Cardiovascular disease risk score	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.	4 months
Secondary	Physical activity	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.	4 months