NCT05720611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

January 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

January 13, 2023

Last Update Submit

November 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    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

    24 weeks

Secondary Outcomes (9)

  • Demand

    Baseline and 24 weeks

  • Practicality

    24 weeks

  • Fruit and vegetable intake

    From baseline to 24 weeks

  • Physical activity

    From baseline to 24 weeks

  • Cooking confidence

    From baseline to 24 weeks

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Interventions

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.

Control GroupIntervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Veldheer S, Rutt K, Schaefer E, Kim I, Hrabovsky S, Smith B, Thomas OW, Moore AM, Pagoto S, Conroy DE, Schmitz KH, Sciamanna C. Growing Healthy Hearts: a pilot randomized controlled trial of a digitally delivered gardening, cooking, and Dietary Approaches to Stop Hypertension (DASH) diet intervention for adults with cardiovascular risk factors. Pilot Feasibility Stud. 2026 Jan 28. doi: 10.1186/s40814-026-01766-1. Online ahead of print.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 9, 2023

Study Start

January 27, 2023

Primary Completion

September 25, 2023

Study Completion

August 1, 2024

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations