Study Stopped
Protocol could not be initiated due to COVID.
Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Health
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2019
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2019
CompletedStudy Start
First participant enrolled
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedJune 22, 2022
June 1, 2022
3.9 years
December 18, 2019
June 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Cardiovascular disease risk score
4 months
Physical activity
4 months
Study Arms (2)
Gardening and Nutrition Advice
EXPERIMENTALParticipate in gardening activities, food demonstrations and nutrition advice
Nutrition Advice alone
PLACEBO COMPARATORParticipate in only nutrition advice
Interventions
Participate in gardening activities, gardening instructions and nutrition advice
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State College of Medicine
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Veldheer, DEd, RD
Penn State College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Department of Family and Community Medicine
Study Record Dates
First Submitted
December 18, 2019
First Posted
December 20, 2019
Study Start
December 19, 2019
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share