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

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04207268
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 46.4
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 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
• Actual Study Start Date: Dec 19, 2019
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

4. Any history of cardiovascular disease

5. Any family history of premature cardiovascular disease

6. Any history of stroke

7. High cholesterol

8. High blood pressure

9. Overweight/obesity (BMI >=25)

10. Diabetes

11. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State College of Medicine	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Susan Veldheer, DEd, RD, Penn State College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Dec 20, 2019
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Susan Veldheer, Assistant Professor, Department of Family and Community Medicine, Milton S. Hershey Medical Center: Cardiovascular disease
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Jun 22, 2022