Growing Healthy Hearts (GHH)
2. Juli 2026 aktualisiert von: 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)
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
264
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Susan Veldheer, DEd, RD
- Telefonnummer: 717-531-5625
- E-Mail: sveldheer@psu.edu
Studieren Sie die Kontaktsicherung
- Name: Kayla Rutt, DrPH
- Telefonnummer: 717-858-6204
- E-Mail: krutt1@pennstatehealth.psu.edu
Studienorte
-
-
Pennsylvania
-
Hershey, Pennsylvania, Vereinigte Staaten, 17033
- Penn State College of Medicine
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Wartelistenkontrolle
|
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Dietary Intake: Fruit and vegetable (FV) intake
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Physical Activity - Fitbit activity volume via step count
Zeitfenster: Baseline
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
Baseline
|
|
Physical Activity - Fitbit activity volume via step count
Zeitfenster: 3 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
3 month
|
|
Physical Activity - Fitbit activity volume via step count
Zeitfenster: 6 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
6 month
|
|
Physical Activity - Fitbit activity volume via step count
Zeitfenster: 1 year follow up
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
1 year follow up
|
|
Biomarkers - total cholesterol
Zeitfenster: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - total cholesterol
Zeitfenster: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - total cholesterol
Zeitfenster: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - total cholesterol
Zeitfenster: 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
Zeitfenster: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - HDL
Zeitfenster: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - HDL
Zeitfenster: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - HDL
Zeitfenster: 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
Zeitfenster: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -LDL
Zeitfenster: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -LDL
Zeitfenster: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -LDL
Zeitfenster: 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
Zeitfenster: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -HbA1c
Zeitfenster: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -HbA1c
Zeitfenster: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -HbA1c
Zeitfenster: 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
Zeitfenster: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -triglycerides
Zeitfenster: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -triglycerides
Zeitfenster: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -triglycerides
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline
|
Height measurement tools will be used to assess changes in participant height for BMI calculation.
|
Baseline
|
|
Measure Weight
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Oktober 2026
Primärer Abschluss (Geschätzt)
1. Oktober 2030
Studienabschluss (Geschätzt)
1. März 2031
Studienanmeldedaten
Zuerst eingereicht
29. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Juni 2026
Zuerst gepostet (Tatsächlich)
6. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- STUDY00029380
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NEIN
Beschreibung des IPD-Plans
There are no plans in order to maintain participant confidentiality.
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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