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Not yet recruiting NCT07684027

Growing Healthy Hearts

No phase Interventional Cardiovascular (CV) Risk Behavioral Changes Gardening Cooking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GHH Intervention.
Who it may be relevant to
Registry conditions: Cardiovascular (CV) Risk, Behavioral Changes, Gardening, Cooking. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Growing Healthy Hearts: A Randomized Controlled Trial of a Multicomponent Gardening Intervention for Adults With Cardiovascular Disease Risk and Their Families.

Overview

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)

Interventions

  • Behavioral GHH Intervention
    This intervention examines 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.

Primary outcome measures

  • Dietary Intake: Fruit and vegetable (FV) intake [Time frame: Baseline]
  • Dietary Intake: Fruit and vegetable (FV) intake [Time frame: 3 month]
  • Dietary Intake: Fruit and vegetable (FV) intake [Time frame: 6 month]
  • Dietary Intake: Fruit and vegetable (FV) intake [Time frame: 1 year follow up]
Secondary outcome measures (12)
  • Physical Activity - Fitbit activity volume via step count [Time frame: Baseline]
  • Physical Activity - Fitbit activity volume via step count [Time frame: 3 month]
  • Physical Activity - Fitbit activity volume via step count [Time frame: 6 month]
  • Physical Activity - Fitbit activity volume via step count [Time frame: 1 year follow up]
  • Biomarkers - total cholesterol [Time frame: Baseline]
  • Biomarkers - total cholesterol [Time frame: 3 month]
  • Biomarkers - total cholesterol [Time frame: 6 month]
  • Biomarkers - total cholesterol [Time frame: 1 year follow up]
  • Biomarkers - HDL [Time frame: Baseline]
  • Biomarkers - HDL [Time frame: 3 month]
  • Biomarkers - HDL [Time frame: 6 month]
  • Biomarkers - HDL [Time frame: 1 year follow up]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Penn State College of Medicine — Hershey

Identifiers

NCT: NCT07684027 · STUDY00029380

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗