Growing Healthy Hearts (GHH)
2. juli 2026 opdateret af: 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)
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
264
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Susan Veldheer, DEd, RD
- Telefonnummer: 717-531-5625
- E-mail: sveldheer@psu.edu
Undersøgelse Kontakt Backup
- Navn: Kayla Rutt, DrPH
- Telefonnummer: 717-858-6204
- E-mail: krutt1@pennstatehealth.psu.edu
Studiesteder
-
-
Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State College of Medicine
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Ventelistekontrol
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Eksperimentel: GHH Intervention
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dietary Intake: Fruit and vegetable (FV) intake
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Activity - Fitbit activity volume via step count
Tidsramme: Baseline
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
Baseline
|
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Physical Activity - Fitbit activity volume via step count
Tidsramme: 3 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
3 month
|
|
Physical Activity - Fitbit activity volume via step count
Tidsramme: 6 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
6 month
|
|
Physical Activity - Fitbit activity volume via step count
Tidsramme: 1 year follow up
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
1 year follow up
|
|
Biomarkers - total cholesterol
Tidsramme: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - total cholesterol
Tidsramme: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - total cholesterol
Tidsramme: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - total cholesterol
Tidsramme: 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
Tidsramme: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - HDL
Tidsramme: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - HDL
Tidsramme: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - HDL
Tidsramme: 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
Tidsramme: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -LDL
Tidsramme: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -LDL
Tidsramme: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -LDL
Tidsramme: 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
Tidsramme: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -HbA1c
Tidsramme: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -HbA1c
Tidsramme: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -HbA1c
Tidsramme: 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
Tidsramme: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -triglycerides
Tidsramme: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -triglycerides
Tidsramme: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -triglycerides
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Height measurement tools will be used to assess changes in participant height for BMI calculation.
|
Baseline
|
|
Measure Weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. oktober 2030
Studieafslutning (Anslået)
1. marts 2031
Datoer for studieregistrering
Først indsendt
29. juni 2026
Først indsendt, der opfyldte QC-kriterier
29. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STUDY00029380
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
There are no plans in order to maintain participant confidentiality.
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