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Growing Healthy Hearts (GHH)

2. července 2026 aktualizováno: Susan Veldheer, Milton S. Hershey Medical Center

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)

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

264

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Susan Veldheer, DEd, RD
  • Telefonní číslo: 717-531-5625
  • E-mail: sveldheer@psu.edu

Studijní záloha kontaktů

Studijní místa

  • Spojené státy
    • Pennsylvania
      • Hershey, Pennsylvania, Spojené státy, 17033
        • Penn State College of Medicine

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Ovládání čekací listiny
Experimentální: GHH Intervention
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Dietary Intake: Fruit and vegetable (FV) intake
Časové okno: 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)
Baseline
Dietary Intake: Fruit and vegetable (FV) intake
Časové okno: 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 month
Dietary Intake: Fruit and vegetable (FV) intake
Časové okno: 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)
6 month
Dietary Intake: Fruit and vegetable (FV) intake
Časové okno: 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)
1 year follow up

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Physical Activity - Fitbit activity volume via step count
Časové okno: Baseline
This data will be collected via wrist worn Fitbit Inspire 3 devices
Baseline
Physical Activity - Fitbit activity volume via step count
Časové okno: 3 month
This data will be collected via wrist worn Fitbit Inspire 3 devices
3 month
Physical Activity - Fitbit activity volume via step count
Časové okno: 6 month
This data will be collected via wrist worn Fitbit Inspire 3 devices
6 month
Physical Activity - Fitbit activity volume via step count
Časové okno: 1 year follow up
This data will be collected via wrist worn Fitbit Inspire 3 devices
1 year follow up
Biomarkers - total cholesterol
Časové okno: Baseline
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Baseline
Biomarkers - total cholesterol
Časové okno: 3 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
3 month
Biomarkers - total cholesterol
Časové okno: 6 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
6 month
Biomarkers - total cholesterol
Časové okno: 1 year follow up
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
1 year follow up
Biomarkers - HDL
Časové okno: Baseline
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Baseline
Biomarkers - HDL
Časové okno: 3 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
3 month
Biomarkers - HDL
Časové okno: 6 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
6 month
Biomarkers - HDL
Časové okno: 1 year follow up
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
1 year follow up
Biomarkers -LDL
Časové okno: Baseline
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Baseline
Biomarkers -LDL
Časové okno: 3 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
3 month
Biomarkers -LDL
Časové okno: 6 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
6 month
Biomarkers -LDL
Časové okno: 1 year follow up
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
1 year follow up
Biomarkers -HbA1c
Časové okno: Baseline
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Baseline
Biomarkers -HbA1c
Časové okno: 3 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
3 month
Biomarkers -HbA1c
Časové okno: 6 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
6 month
Biomarkers -HbA1c
Časové okno: 1 year follow up
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
1 year follow up
Biomarkers -triglycerides
Časové okno: Baseline
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Baseline
Biomarkers -triglycerides
Časové okno: 3 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
3 month
Biomarkers -triglycerides
Časové okno: 6 month
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
6 month
Biomarkers -triglycerides
Časové okno: 1 year follow up
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
1 year follow up
Blood Pressure
Časové okno: 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.
Baseline
Blood Pressure
Časové okno: 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.
3 month
Blood Pressure
Časové okno: 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.
6 month
Blood Pressure
Časové okno: 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.
1 year follow up
Measure Height
Časové okno: Baseline
Height measurement tools will be used to assess changes in participant height for BMI calculation.
Baseline
Measure Weight
Časové okno: 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
Baseline
Measure Weight
Časové okno: 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
3 month
Measure Weight
Časové okno: 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
6 month
Measure Weight
Časové okno: 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
1 year follow up
Household Food Security
Časové okno: 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.
Baseline
Household Food Security
Časové okno: 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.
3 month
Household Food Security
Časové okno: 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.
6 month
Household Food Security
Časové okno: 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.
1 year follow up
General Nutrition Knowledge
Časové okno: Baseline
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Baseline
General Nutrition Knowledge
Časové okno: 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).
3 month
General Nutrition Knowledge
Časové okno: 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)
6 month
General Nutrition Knowledge
Časové okno: 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)
1 year follow up
Home Meal Preparation
Časové okno: 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).
Baseline
Home Meal Preparation
Časové okno: 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).
3 month
Home Meal Preparation
Časové okno: 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).
6 month
Home Meal Preparation
Časové okno: 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).
1 year follow up
Cooking skills
Časové okno: Baseline
The Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Baseline
Cooking skills
Časové okno: 3 month
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
3 month
Cooking skills
Časové okno: 6 month
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
6 month
Cooking skills
Časové okno: 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.
1 year follow up
Social support
Časové okno: 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).
Baseline
Social support
Časové okno: 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).
3 month
Social support
Časové okno: 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).
6 month
Social support
Časové okno: 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).
1 year follow up

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Milton S. Hershey Medical Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. října 2026

Primární dokončení (Odhadovaný)

1. října 2030

Dokončení studie (Odhadovaný)

1. března 2031

Termíny zápisu do studia

První předloženo

29. června 2026

První předloženo, které splnilo kritéria kontroly kvality

29. června 2026

První zveřejněno (Aktuální)

6. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • STUDY00029380

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

There are no plans in order to maintain participant confidentiality.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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