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Completed

NCT Number: NCT05720611

Growing Healthy Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease

This study aims to assess the effectiveness on an online gardening study for beginner gardeners with the goal of improving diet and physical activity in those with at least one risk factor for cardiovascular disease.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

The purpose of this study is to test the feasibility of an online gardening and nutrition intervention in adults with risk factors for cardiovascular disease using a randomized controlled trial design. During the trial, the intervention condition will learn how to start a garden plot (either at home or in a community garden) and grow fruits and vegetables for personal consumption. We will also provide this group with nutrition education related to the DASH diet and basic cooking skills instruction. The control condition participants will receive no intervention during the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are at least 20 years old
  • Have any one or more health condition(s) or risk factor(s) for CVD. These include, but are not limited to:
  • Any history of cardiovascular disease
  • Any family history of cardiovascular disease (as measured by asking if both living and deceased, close biological relatives, that is, blood relatives including father, mother, sisters or brothers, ever told by a health professional that they had a heart attack or angina before the age of 50)
  • Any history of stroke or DVT
  • High cholesterol
  • High blood pressure
  • Overweight/obesity (BMI >=25)
  • Diabetes, prediabetes, or borderline diabetes
  • Current or past Tobacco use
  • Reports consuming fruit and vegetables less than 5 times per day
  • Report less than 150 minutes of physical activity per week
  • Have access to stable and consistent internet access
  • Have a Facebook account or willing to open a Facebook account
  • Have a smart phone or computer and capacity to download the Fitbit app or Fitbit Connect Software
  • Must be willing to wear a Fitbit tracker almost continually (23.5 hours/day) for duration of study
  • Have access to a kitchen in or near their living space
  • Has access to space to start a garden (at home or in a community garden either in the ground, raised beds, or containers)

Exclusion criteria

  • Unwilling to participate in Zoom sessions and have their voice and face recorded for research purposes.
  • Currently tends a vegetable garden (as measured by if they have tended a garden in the past year or are planning to tend a garden (outside of this study) in the coming season)
  • Moving out of the area in the next 5 months
  • Non-English speaking or reading
  • Pregnant women
  • Participation in a past FCM gardening intervention 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, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or allergies.
  • Close contacts of current participants in the study

Treatment and study plan

Digitally delivered gardening and healthy eating course

Behavioral

The intervention group will consist of a digitally delivered course designed to teach gardening, cooking and nutrition education to adults with risk factors for CVD. Participants will be invited to participate in 10 Zoom-based gardening and cooking education sessions. Zoom meetings will be facilitated by members of the study team, will present information to participants and will allow participants to ask questions and share their experiences with others. The materials will walk the participant through various aspects of starting and tending a garden.

Primary outcomes

  1. Acceptability

    Time frame: 24 weeks

    Participant acceptability of the program based on 80% of intervention participants providing an average rating of the intervention as 4 or higher on the Weiner Acceptability Scale

Secondary outcomes

  1. Demand

    Time frame: Baseline and 24 weeks

    Participant demand in terms of 1) ability to recruit 40 participants at baseline and 2) ability to retain at least 70% of participants as measured by number of participants who complete the follow up questionnaires at the 24 week time point

  2. Practicality

    Time frame: 24 weeks

    80% of intervention group participants report completing 16 out of 20 gardening-related study tasks.

  3. Fruit and vegetable intake

    Time frame: From baseline to 24 weeks

    Between group differences in servings of fruits and vegetables from baseline to 24 weeks as assessed by the National Cancer Institute's Diet History Questionnaire 3

  4. Physical activity

    Time frame: From baseline to 24 weeks

    Between group differences in minutes of self-reported physical activity from baseline to 24 weeks as assessed by the International Physical Activity Questionnaire short form.

  5. Cooking confidence

    Time frame: From baseline to 24 weeks

    Between group differences in self-reported cooking confidence score as assessed by the Cooking and Food Skills (Lavelle et al. 2017)

  6. Gardening confidence

    Time frame: From baseline to 24 weeks

    Between group differences in total gardening confidence score as assessed by a 20 item gardening task questionnaire on confidence to complete gardening tasks using a 10 point Likert scale.

  7. Gardening enjoyment

    Time frame: From baseline to 24 weeks

    Between group differences in the total intrinsic motivation score for gardening activity as measured by the Intrinsic Motivations Questionnaire.

  8. Social support-Healthy eating

    Time frame: From baseline to 24 weeks

    Between group differences the self-reported Social Support for Healthy Eating Questionnaire (Salis et al., 1987).

  9. Social support-physical activity

    Time frame: From baseline to 24 weeks

    Between group differences in the self-reported Social Support for Physical Activity Questionnaire (Salis et al, 1987)

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

Growing Health Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 9, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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