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NCT Number: NCT07684027

Growing Healthy Hearts

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)

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Key information

Conditions

Cardiovascular (CV) Risk Behavioral Changes Cooking Gardening Nutrition Education

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Physical Activity - Fitbit activity volume via step count

    Time frame: Baseline

    This data will be collected via wrist worn Fitbit Inspire 3 devices

  2. Physical Activity - Fitbit activity volume via step count

    Time frame: 3 month

    This data will be collected via wrist worn Fitbit Inspire 3 devices

  3. Physical Activity - Fitbit activity volume via step count

    Time frame: 6 month

    This data will be collected via wrist worn Fitbit Inspire 3 devices

  4. Physical Activity - Fitbit activity volume via step count

    Time frame: 1 year follow up

    This data will be collected via wrist worn Fitbit Inspire 3 devices

  5. Biomarkers - total cholesterol

    Time frame: Baseline

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  6. Biomarkers - total cholesterol

    Time frame: 3 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  7. Biomarkers - total cholesterol

    Time frame: 6 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  8. Biomarkers - total cholesterol

    Time frame: 1 year follow up

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  9. Biomarkers - HDL

    Time frame: Baseline

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  10. Biomarkers - HDL

    Time frame: 3 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  11. Biomarkers - HDL

    Time frame: 6 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  12. Biomarkers - HDL

    Time frame: 1 year follow up

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  13. Biomarkers -LDL

    Time frame: Baseline

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  14. Biomarkers -LDL

    Time frame: 3 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  15. Biomarkers -LDL

    Time frame: 6 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  16. Biomarkers -LDL

    Time frame: 1 year follow up

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  17. Biomarkers -HbA1c

    Time frame: Baseline

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  18. Biomarkers -HbA1c

    Time frame: 3 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  19. Biomarkers -HbA1c

    Time frame: 6 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  20. Biomarkers -HbA1c

    Time frame: 1 year follow up

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  21. Biomarkers -triglycerides

    Time frame: Baseline

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  22. Biomarkers -triglycerides

    Time frame: 3 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  23. Biomarkers -triglycerides

    Time frame: 6 month

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  24. Biomarkers -triglycerides

    Time frame: 1 year follow up

    These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease

  25. Blood Pressure

    Time frame: Baseline

    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.

  26. Blood Pressure

    Time frame: 3 month

    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.

  27. Blood Pressure

    Time frame: 6 month

    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.

  28. Blood Pressure

    Time frame: 1 year follow up

    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.

  29. Measure Height

    Time frame: Baseline

    Height measurement tools will be used to assess changes in participant height for BMI calculation.

  30. Measure Weight

    Time frame: Baseline

    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

  31. Measure Weight

    Time frame: 3 month

    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

  32. Measure Weight

    Time frame: 6 month

    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

  33. Measure Weight

    Time frame: 1 year follow up

    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

  34. Household Food Security

    Time frame: Baseline

    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.

  35. Household Food Security

    Time frame: 3 month

    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.

  36. Household Food Security

    Time frame: 6 month

    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.

  37. Household Food Security

    Time frame: 1 year follow up

    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.

  38. General Nutrition Knowledge

    Time frame: Baseline

    General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)

  39. General Nutrition Knowledge

    Time frame: 3 month

    General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome).

  40. General Nutrition Knowledge

    Time frame: 6 month

    General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)

  41. General Nutrition Knowledge

    Time frame: 1 year follow up

    General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)

  42. Home Meal Preparation

    Time frame: Baseline

    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).

  43. Home Meal Preparation

    Time frame: 3 month

    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).

  44. Home Meal Preparation

    Time frame: 6 month

    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).

  45. Home Meal Preparation

    Time frame: 1 year follow up

    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).

  46. Cooking skills

    Time frame: Baseline

    The Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.

  47. Cooking skills

    Time frame: 3 month

    The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.

  48. Cooking skills

    Time frame: 6 month

    The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.

  49. Cooking skills

    Time frame: 1 year follow up

    The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.

  50. Social support

    Time frame: Baseline

    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).

  51. Social support

    Time frame: 3 month

    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).

  52. Social support

    Time frame: 6 month

    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).

  53. Social support

    Time frame: 1 year follow up

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Rutt, DrPH

CONTACT

[email protected]

717-858-6204

Susan Veldheer, DEd, RD

CONTACT

[email protected]

717-531-5625

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Acronym: GHH

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 6, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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