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

Not Applicable

Withdrawn

• Conditions: Cardiovascular Diseases
• Interventions: Behavioral: Nutrition Advice; Behavioral: Gardening and Nutrition Advice

• Registration Number: NCT04207268
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2019-12-18
• Study Start: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Advice alone	Nutrition Advice	Participate in only nutrition advice
Gardening and Nutrition Advice	Gardening and Nutrition Advice	Participate in gardening activities, food demonstrations and nutrition advice

Primary Outcome Measures

Name	Time	Method
Plasma Carotenoids	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.
Self-reported dietary intake	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

Name	Time	Method
Physical activity	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.
Cardiovascular disease risk score	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.

Trial Locations

Locations (1)

Penn State College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States