Cardiovascular (CV) RiskGHHNCT07684027
Growing Healthy Hearts
A study testing GHH Intervention in people with Cardiovascular (CV) Risk and Behavioral Changes, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular (CV) Risk, Behavioral Changes, Gardening
- What is being tested?
- GHH Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn State College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: 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)
- Being tested
- GHH Intervention
- Keywords
- self-determination theory, CVD risk factors, diet quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GHH InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GHH Intervention | Experimental | Not described Receives: Behavioral: GHH Intervention |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 year follow up
Secondary outcomes (53)
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Measured: Baseline
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Measured: 3 month
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Measured: 6 month
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Measured: 1 year follow up
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: Baseline
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 3 month
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 6 month
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 1 year follow up
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: Baseline
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 3 month
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 6 month
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 1 year follow up
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: Baseline
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 3 month
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 6 month
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 1 year follow up
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: Baseline
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 3 month
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 6 month
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 1 year follow up
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: Baseline
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 3 month
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 6 month
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year follow up
Measure Height
Height measurement tools will be used to assess changes in participant height for BMI calculation.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year follow up
Household Food Security
18-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.
Measured: Baseline
Household Food Security
18-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.
Measured: 3 month
Household Food Security
18-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.
Measured: 6 month
Household Food Security
18-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.
Measured: 1 year follow up
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Measured: Baseline
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome).
Measured: 3 month
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Measured: 6 month
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Measured: 1 year follow up
Home Meal Preparation
The 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).
Measured: Baseline
Home Meal Preparation
The 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).
Measured: 3 month
Home Meal Preparation
The 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).
Measured: 6 month
Home Meal Preparation
The 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).
Measured: 1 year follow up
Cooking skills
The Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Measured: Baseline
Cooking skills
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Measured: 3 month
Cooking skills
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Measured: 6 month
Cooking skills
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Measured: 1 year follow up
Social support
The 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).
Measured: Baseline
Social support
The 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).
Measured: 3 month
Social support
The 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).
Measured: 6 month
Social support
The 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).
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular (CV) RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Veldheer, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684027
- Sponsor's protocol ID
- STUDY00029380
- Acronym
- GHH
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans in order to maintain participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growing Healthy Hearts: A Randomized Controlled Trial of a Multicomponent Gardening Intervention for Adults With Cardiovascular Disease Risk and Their Families.
- ClinicalTrials.gov ID
- NCT07684027
- Acronym / sponsor ID
- GHH / STUDY00029380
- Keywords
- self-determination theory, CVD risk factors, diet quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GHH Intervention | Experimental | Behavioral: GHH Intervention |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GHH InterventionThis 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. | Behavioural | GHH Intervention |
Primary outcome
Dietary Intake: Fruit and vegetable (FV) intake
Time frame: Baseline
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)
Dietary Intake: Fruit and vegetable (FV) intake
Time frame: 3 month
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)
Dietary Intake: Fruit and vegetable (FV) intake
Time frame: 6 month
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)
Dietary Intake: Fruit and vegetable (FV) intake
Time frame: 1 year follow up
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)
53 secondary outcomes
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
Biomarkers -LDL
Time frame: Baseline
Biomarkers -LDL
Time frame: 3 month
Biomarkers -LDL
Time frame: 6 month
Biomarkers -LDL
Time frame: 1 year follow up
Biomarkers -HbA1c
Time frame: Baseline
Biomarkers -HbA1c
Time frame: 3 month
Biomarkers -HbA1c
Time frame: 6 month
Biomarkers -HbA1c
Time frame: 1 year follow up
Biomarkers -triglycerides
Time frame: Baseline
Biomarkers -triglycerides
Time frame: 3 month
Biomarkers -triglycerides
Time frame: 6 month
Biomarkers -triglycerides
Time frame: 1 year follow up
Blood Pressure
Time frame: Baseline
Blood Pressure
Time frame: 3 month
Blood Pressure
Time frame: 6 month
Blood Pressure
Time frame: 1 year follow up
Measure Height
Time frame: Baseline
Measure Weight
Time frame: Baseline
Measure Weight
Time frame: 3 month
Measure Weight
Time frame: 6 month
Measure Weight
Time frame: 1 year follow up
Household Food Security
Time frame: Baseline
Household Food Security
Time frame: 3 month
Household Food Security
Time frame: 6 month
Household Food Security
Time frame: 1 year follow up
General Nutrition Knowledge
Time frame: Baseline
General Nutrition Knowledge
Time frame: 3 month
General Nutrition Knowledge
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. There are no plans in order to maintain participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GHH Intervention in people with Cardiovascular (CV) Risk and Behavioral Changes, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Veldheer, DEd, RD (717-531-5625, sveldheer@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Intake: Fruit and vegetable (FV) intake (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.