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Growing Healthy Hearts

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07684027
Acronym
GHH
Enrollment
264
Registered
2026-07-06
Start date
2026-10-01
Completion date
2031-03-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

self-determination theory, CVD risk factors, diet quality

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)

Interventions

BEHAVIORALGHH 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.

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Dietary Intake: Fruit and vegetable (FV) intakeBaselineTrained 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)

Secondary

MeasureTime frameDescription
Physical Activity - Fitbit activity volume via step countBaselineThis data will be collected via wrist worn Fitbit Inspire 3 devices
Biomarkers - total cholesterolBaselineThese at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Biomarkers - HDLBaselineThese at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Biomarkers -LDLBaselineThese at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Biomarkers -HbA1cBaselineThese at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Biomarkers -triglyceridesBaselineThese at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Blood PressureBaselineThe 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.
Measure HeightBaselineHeight measurement tools will be used to assess changes in participant height for BMI calculation.
Measure WeightBaselineScales 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
Household Food SecurityBaseline18-item United States Household Food Security Survey Module will assess home food security for adults and children. Scale yields scores from 0-18 with lower scores indicating higher food security.
General Nutrition KnowledgeBaselineGeneral Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Home Meal PreparationBaselineThe National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
Cooking skillsBaselineThe Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Social supportBaselineThe Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).

Countries

United States

Contacts

CONTACTSusan Veldheer, DEd, RD
sveldheer@psu.edu717-531-5625
CONTACTKayla Rutt, DrPH
krutt1@pennstatehealth.psu.edu717-858-6204

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026