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

NCT ID: NCT04207268

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Gardening and Nutrition Advice

Participate in gardening activities, food demonstrations and nutrition advice

Group Type EXPERIMENTAL

Gardening and Nutrition Advice

Intervention Type BEHAVIORAL

Participate in gardening activities, gardening instructions and nutrition advice

Nutrition Advice alone

Participate in only nutrition advice

Group Type PLACEBO_COMPARATOR

Nutrition Advice

Intervention Type BEHAVIORAL

Participate in only nutrition advice

Interventions

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Gardening and Nutrition Advice

Participate in gardening activities, gardening instructions and nutrition advice

Intervention Type BEHAVIORAL

Nutrition Advice

Participate in only nutrition advice

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Susan Veldheer

Assistant Professor, Department of Family and Community Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Veldheer, DEd, RD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

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Penn State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00013976

Identifier Type: -

Identifier Source: org_study_id

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