Growing Healthy Hearts (GHH)

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Behavioral Changes; Cooking; Cardiovascular (CV) Risk; Nutrition Education; Gardening
• Intervention / Treatment: Behavioral: GHH Intervention

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Veldheer, DEd, RD; Phone Number: 717-531-5625; Email: sveldheer@psu.edu
• Study Contact Backup: Name: Kayla Rutt, DrPH; Phone Number: 717-858-6204; Email: krutt1@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control
Experimental: GHH Intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Intake: Fruit and vegetable (FV) intake	Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Diet data will be analyzed using the Nutrition Data System for Research (NDSR)	Baseline
Dietary Intake: Fruit and vegetable (FV) intake	Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Data will be analyzed using the Nutrition Data System for Research (NDSR)	3 month
Dietary Intake: Fruit and vegetable (FV) intake	Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Data will be analyzed using the Nutrition Data System for Research (NDSR)	6 month
Dietary Intake: Fruit and vegetable (FV) intake	Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Data will be analyzed using the Nutrition Data System for Research (NDSR)	1 year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity - Fitbit activity volume via step count	This data will be collected via wrist worn Fitbit Inspire 3 devices	Baseline
Physical Activity - Fitbit activity volume via step count	This data will be collected via wrist worn Fitbit Inspire 3 devices	3 month
Physical Activity - Fitbit activity volume via step count	This data will be collected via wrist worn Fitbit Inspire 3 devices	6 month
Physical Activity - Fitbit activity volume via step count	This data will be collected via wrist worn Fitbit Inspire 3 devices	1 year follow up
Biomarkers - total cholesterol	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	Baseline
Biomarkers - total cholesterol	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	3 month
Biomarkers - total cholesterol	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	6 month
Biomarkers - total cholesterol	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	1 year follow up
Biomarkers - HDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	Baseline
Biomarkers - HDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	3 month
Biomarkers - HDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	6 month
Biomarkers - HDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	1 year follow up
Biomarkers -LDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	Baseline
Biomarkers -LDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	3 month
Biomarkers -LDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	6 month
Biomarkers -LDL	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	1 year follow up
Biomarkers -HbA1c	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	Baseline
Biomarkers -HbA1c	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	3 month
Biomarkers -HbA1c	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	6 month
Biomarkers -HbA1c	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	1 year follow up
Biomarkers -triglycerides	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	Baseline
Biomarkers -triglycerides	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	3 month
Biomarkers -triglycerides	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	6 month
Biomarkers -triglycerides	These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease	1 year follow up
Blood Pressure	The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.	Baseline
Blood Pressure	The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.	3 month
Blood Pressure	The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.	6 month
Blood Pressure	The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.	1 year follow up
Measure Height	Height measurement tools will be used to assess changes in participant height for BMI calculation.	Baseline
Measure Weight	Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children	Baseline
Measure Weight	Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children	3 month
Measure Weight	Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children	6 month
Measure Weight	Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children	1 year follow up
Household Food Security	USDA Food Security Survey Module	Baseline
Household Food Security	USDA Food Security Survey Module	3 month
Household Food Security	USDA Food Security Survey Module	6 month
Household Food Security	USDA Food Security Survey Module	1 year follow up
Nutrition Knowledge	General Nutrition Knowledge Questionnaire	Baseline
Nutrition Knowledge	General Nutrition Knowledge Questionnaire	3 month
Nutrition Knowledge	General Nutrition Knowledge Questionnaire	6 month
Nutrition Knowledge	General Nutrition Knowledge Questionnaire	1 year follow up
Home Meal Preparation	NHANES home meal preparation questionnaire	Baseline
Home Meal Preparation	NHANES home meal preparation questionnaire	3 month
Home Meal Preparation	NHANES home meal preparation questionnaire	6 month
Home Meal Preparation	NHANES home meal preparation questionnaire	1 year follow up
Cooking skills	Cooking and food skills questionnaire	Baseline
Cooking skills	Cooking and food skills questionnaire	3 month
Cooking skills	Cooking and food skills questionnaire	6 month
Cooking skills	Cooking and food skills questionnaire	1 year follow up
Social support	Social support scale	Baseline
Social support	Social support scale	3 month
Social support	Social support scale	6 month
Social support	Social support scale	1 year follow up

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: diet quality; self-determination theory; CVD risk factors
• Other Study ID Numbers: STUDY00029380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans in order to maintain participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No