Not Yet RecruitingNot Applicable

Growing Healthy Hearts

United States264 participantsStarted 2026-10

Plain-language summary

This proposal includes a prospective, parallel group, two-arm RCT with 264 adult-child dyads (adult age 18+, child ages 5-17 years) to examine the effectiveness of the Growing Healthy Hearts (GHH) intervention versus a wait list control on cardiovascular and behavioral health outcomes at 3-, 6- and 12-months follow-up (Aim 1). This proposal will also examine the effect of GHH on home fruit and vegetable (FV) availability, frequency of home-prepared meals that include FV, and child behaviors (FV intake and PA) at 3-, 6- and 12-month follow-up (Aim 2) and intervention implementation (Aim 3)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 or older who are interested in gardening but have no plans to garden in the coming season. * Participants will also be required to: 1) have at least one child (aged 5-17) living in the household with them * Have access to space for a garden (either at home or in a community garden space where they could plant any combination of in-ground, raised beds, and/or container gardens * Have a smartphone capable of downloading an app and syncing with a Fitbit * Access to the internet * Have or are willing to create a Facebook account * Report ≤90 minutes of moderate or vigorous physical activity /week * Report \<5 servings of fruit and vegetables per day * Have any one additional self-reported CVD risk factor (e.g., BMI ≥25, family history of premature CVD, high blood pressure, high cholesterol, diabetes, current or past tobacco use) Exclusion Criteria: * Adults who are pregnant * Have medical conditions that significantly limit an individual's ability to participate in gardening (e.g., knee or back pain, heart attack/stroke in the past year, recent or pending surgeries * Uncontrolled allergies, other serious physical disabilities, uncontrolled asthma) * Medical conditions that may limit participants from increasing FV intake (e.g., kidney failure or dialysis)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial focuses on gardening, cooking, and nutrition education to reduce cardiovascular risk — given my specific heart health situation, do you think changing my diet and lifestyle habits through a program like this could actually make a meaningful difference for me?
2Since this trial isn't recruiting yet, how long might it realistically be before I could even join, and should I be pursuing other treatment or lifestyle interventions in the meantime?
3The main thing this study is measuring is how much fruit and vegetable intake changes — is that a meaningful enough marker for my cardiovascular risk, or would you want to see other factors like blood pressure or cholesterol tracked alongside it?
4This trial is listed as Phase NA, which suggests it's more of a behavioral or educational study than a drug trial — does that change the risk profile compared to other studies you might recommend, and what would I actually be committing to on a day-to-day basis?
5Are there existing, proven nutrition or lifestyle programs you'd recommend I try now rather than waiting for this trial to open, and how would you compare their likely benefit to what this study is trying to achieve?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dietary Intake: Fruit and vegetable (FV) intake

Timeframe: Baseline

Dietary Intake: Fruit and vegetable (FV) intake

Timeframe: 3 month

Dietary Intake: Fruit and vegetable (FV) intake

Timeframe: 6 month

Dietary Intake: Fruit and vegetable (FV) intake

Timeframe: 1 year follow up

Trial details

NCT IDNCT07684027

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-10

Contact for this trial

Susan Veldheer, DEd, RD

717-531-5625 sveldheer@psu.edu

View on ClinicalTrials.gov More Cardiovascular (CV) Risk trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.