Growing Healthy Hearts (GHH)
2 luglio 2026 aggiornato da: 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)
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
264
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Susan Veldheer, DEd, RD
- Numero di telefono: 717-531-5625
- Email: sveldheer@psu.edu
Backup dei contatti dello studio
- Nome: Kayla Rutt, DrPH
- Numero di telefono: 717-858-6204
- Email: krutt1@pennstatehealth.psu.edu
Luoghi di studio
-
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State College of Medicine
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Controllo della lista d'attesa
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Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dietary Intake: Fruit and vegetable (FV) intake
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physical Activity - Fitbit activity volume via step count
Lasso di tempo: Baseline
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
Baseline
|
|
Physical Activity - Fitbit activity volume via step count
Lasso di tempo: 3 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
3 month
|
|
Physical Activity - Fitbit activity volume via step count
Lasso di tempo: 6 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
6 month
|
|
Physical Activity - Fitbit activity volume via step count
Lasso di tempo: 1 year follow up
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
1 year follow up
|
|
Biomarkers - total cholesterol
Lasso di tempo: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - total cholesterol
Lasso di tempo: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - total cholesterol
Lasso di tempo: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - total cholesterol
Lasso di tempo: 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
Lasso di tempo: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - HDL
Lasso di tempo: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - HDL
Lasso di tempo: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - HDL
Lasso di tempo: 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
Lasso di tempo: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -LDL
Lasso di tempo: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -LDL
Lasso di tempo: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -LDL
Lasso di tempo: 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
Lasso di tempo: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -HbA1c
Lasso di tempo: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -HbA1c
Lasso di tempo: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -HbA1c
Lasso di tempo: 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
Lasso di tempo: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -triglycerides
Lasso di tempo: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -triglycerides
Lasso di tempo: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -triglycerides
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
Height measurement tools will be used to assess changes in participant height for BMI calculation.
|
Baseline
|
|
Measure Weight
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 ottobre 2026
Completamento primario (Stimato)
1 ottobre 2030
Completamento dello studio (Stimato)
1 marzo 2031
Date di iscrizione allo studio
Primo inviato
29 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 giugno 2026
Primo Inserito (Effettivo)
6 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- STUDY00029380
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
There are no plans in order to maintain participant confidentiality.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .