Growing Healthy Hearts

NCT07684027 | Not Yet Recruiting

• 1 other identifier: STUDY00029380
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Cardiovascular (CV) Risk; Behavioral Changes; Gardening; Cooking; Nutrition Education

Keywords

self-determination theory; CVD risk factors; diet quality

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (53)

• Physical Activity - Fitbit activity volume via step count

  Baseline

• Physical Activity - Fitbit activity volume via step count

  3 month

• Physical Activity - Fitbit activity volume via step count

  6 month

• Physical Activity - Fitbit activity volume via step count

  1 year follow up

• Biomarkers - total cholesterol

  Baseline

Study Arms (2)

GHH Intervention

EXPERIMENTAL

Behavioral: GHH Intervention

Waitlist Control

NO INTERVENTION

Interventions

GHH Intervention BEHAVIORAL

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.

GHH Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Central Study Contacts

Susan Veldheer, DEd, RD

CONTACT

717-531-5625; sveldheer@psu.edu

Kayla Rutt, DrPH

CONTACT

717-858-6204; krutt1@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Department of Family and Community Medicine

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)