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Clinical Trials/NCT04207268
NCT04207268
Withdrawn
Not Applicable

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

Milton S. Hershey Medical Center1 site in 1 countryDecember 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Milton S. Hershey Medical Center
Locations
1
Primary Endpoint
Plasma Carotenoids
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 19, 2019
End Date
October 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Veldheer

Assistant Professor, Department of Family and Community Medicine

Milton S. Hershey Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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)
  • Current or past Tobacco use

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Physical activity(4 months)
  • Cardiovascular disease risk score(4 months)

Study Sites (1)

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