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

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05720611
Collaborator
(none)
40
2
20.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digitally delivered gardening and healthy eating course
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Growing Health Hearts: An Online Gardening Program for Adults With Risk Factors for Cardiovascular Disease
Anticipated Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
Sep 25, 2023
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group

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. Participants will be asked to engage in a closed Facebook group.

Behavioral: Digitally delivered gardening and healthy eating course
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.

Placebo Comparator: Control Group

Participants in this group will complete all questionnaires but will not receive the digitally delivered course or access to Facebook.

Behavioral: Digitally delivered gardening and healthy eating course
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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability [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 Outcome Measures

  1. Demand [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 [24 weeks]

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

  3. Fruit and vegetable intake [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 [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 [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 [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 [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 [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 [From baseline to 24 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Are at least 20 years old

  2. Have any one or more health condition(s) or risk factor(s) for CVD. These include, but are not limited to:

  3. Any history of cardiovascular disease

  4. 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)

  5. Any history of stroke or DVT

  6. High cholesterol

  7. High blood pressure

  8. Overweight/obesity (BMI >=25)

  9. Diabetes, prediabetes, or borderline diabetes

  10. Current or past Tobacco use

  11. Reports consuming fruit and vegetables less than 5 times per day

  12. Report less than 150 minutes of physical activity per week

  13. Have access to stable and consistent internet access

  14. Have a Facebook account or willing to open a Facebook account

  15. Have a smart phone or computer and capacity to download the Fitbit app or Fitbit Connect Software

  16. Must be willing to wear a Fitbit tracker almost continually (23.5 hours/day) for duration of study

  17. Have access to a kitchen in or near their living space

  18. 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:
  1. Unwilling to participate in Zoom sessions and have their voice and face recorded for research purposes.

  2. 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)

  3. Moving out of the area in the next 5 months

  4. Non-English speaking or reading

  5. Pregnant women

  6. Participation in a past FCM gardening intervention study

  7. Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)

  8. 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.

  9. Close contacts of current participants in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Milton S. Hershey Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Susan Veldheer, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT05720611
Other Study ID Numbers:
  • STUDY00017020
First Posted:
Feb 9, 2023
Last Update Posted:
Feb 9, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2023