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Growing Healthy Hearts for Cardiovascular Risk

(GHH Trial)

SV
KR
Overseen ByKayla Rutt, DrPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Milton S. Hershey Medical Center
Disqualifiers: Pregnancy, Knee/back pain, Heart attack, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Are You a Good Fit for This Trial?

This trial is for adult-child pairs (adults 18+ and children ages 5-17) interested in improving heart health. Participants should be able to take part in gardening, cooking, and nutrition activities. Specific inclusion or exclusion criteria are not detailed.

Inclusion Criteria

Have access to space for a garden at home or in a community garden space suitable for in-ground, raised beds, or container gardens
Report 90 minutes or less of moderate or vigorous physical activity per week
Report fewer than 5 servings of fruit and vegetables per day
See 6 more

Exclusion Criteria

I am currently pregnant.
I do not have medical conditions that prevent me from eating more fruits and vegetables.
I do not have uncontrolled allergies, serious disabilities, or uncontrolled asthma.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Growing Healthy Hearts (GHH) intervention, which includes gardening activities and education on cardiovascular and behavioral health

12 months
4 visits (in-person) at baseline, midpoint, and follow-up assessments

Follow-up

Participants are monitored for cardiovascular and behavioral health outcomes, including dietary intake and physical activity, at 3-, 6-, and 12-month intervals

12 months
3 follow-up assessments (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Growing Healthy Hearts (GHH) Intervention

Trial Overview

The study compares the Growing Healthy Hearts program—which includes gardening, cooking, and nutrition education—to a waitlist control group. The goal is to see if the program improves heart health and healthy behaviors over up to one year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: GHH InterventionExperimental Treatment1 Intervention
Group II: Waitlist ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials
515
Recruited
2,873,000+

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