Growing Healthy Hearts (GHH)
2 lipca 2026 zaktualizowane przez: 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)
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
264
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Susan Veldheer, DEd, RD
- Numer telefonu: 717-531-5625
- E-mail: sveldheer@psu.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Kayla Rutt, DrPH
- Numer telefonu: 717-858-6204
- E-mail: krutt1@pennstatehealth.psu.edu
Lokalizacje studiów
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Pennsylvania
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Hershey, Pennsylvania, Stany Zjednoczone, 17033
- Penn State College of Medicine
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Kontrola listy oczekujących
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Eksperymentalny: 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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Dietary Intake: Fruit and vegetable (FV) intake
Ramy czasowe: 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)
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Baseline
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Dietary Intake: Fruit and vegetable (FV) intake
Ramy czasowe: 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
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Dietary Intake: Fruit and vegetable (FV) intake
Ramy czasowe: 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
Ramy czasowe: 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)
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1 year follow up
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Physical Activity - Fitbit activity volume via step count
Ramy czasowe: Baseline
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
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Baseline
|
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Physical Activity - Fitbit activity volume via step count
Ramy czasowe: 3 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
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3 month
|
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Physical Activity - Fitbit activity volume via step count
Ramy czasowe: 6 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
6 month
|
|
Physical Activity - Fitbit activity volume via step count
Ramy czasowe: 1 year follow up
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
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1 year follow up
|
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Biomarkers - total cholesterol
Ramy czasowe: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
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Baseline
|
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Biomarkers - total cholesterol
Ramy czasowe: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
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Biomarkers - total cholesterol
Ramy czasowe: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
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Biomarkers - total cholesterol
Ramy czasowe: 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
|
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Biomarkers - HDL
Ramy czasowe: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
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Biomarkers - HDL
Ramy czasowe: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
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Biomarkers - HDL
Ramy czasowe: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
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Biomarkers - HDL
Ramy czasowe: 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
|
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Biomarkers -LDL
Ramy czasowe: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
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Biomarkers -LDL
Ramy czasowe: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -LDL
Ramy czasowe: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -LDL
Ramy czasowe: 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
|
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Biomarkers -HbA1c
Ramy czasowe: Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
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Biomarkers -HbA1c
Ramy czasowe: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -HbA1c
Ramy czasowe: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -HbA1c
Ramy czasowe: 1 year follow up
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
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Biomarkers -triglycerides
Ramy czasowe: Baseline
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
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Biomarkers -triglycerides
Ramy czasowe: 3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
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Biomarkers -triglycerides
Ramy czasowe: 6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
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Biomarkers -triglycerides
Ramy czasowe: 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
|
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Blood Pressure
Ramy czasowe: Baseline
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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
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Blood Pressure
Ramy czasowe: 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.
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3 month
|
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Blood Pressure
Ramy czasowe: 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
|
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Blood Pressure
Ramy czasowe: 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.
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1 year follow up
|
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Measure Height
Ramy czasowe: Baseline
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Height measurement tools will be used to assess changes in participant height for BMI calculation.
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Baseline
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Measure Weight
Ramy czasowe: 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
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Baseline
|
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Measure Weight
Ramy czasowe: 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
|
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Measure Weight
Ramy czasowe: 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
|
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Measure Weight
Ramy czasowe: 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
|
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Household Food Security
Ramy czasowe: 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.
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Baseline
|
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Household Food Security
Ramy czasowe: 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
|
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Household Food Security
Ramy czasowe: 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
|
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Household Food Security
Ramy czasowe: 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
|
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General Nutrition Knowledge
Ramy czasowe: Baseline
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General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
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Baseline
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General Nutrition Knowledge
Ramy czasowe: 3 month
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General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome).
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3 month
|
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General Nutrition Knowledge
Ramy czasowe: 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)
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6 month
|
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General Nutrition Knowledge
Ramy czasowe: 1 year follow up
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General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
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1 year follow up
|
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Home Meal Preparation
Ramy czasowe: Baseline
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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).
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Baseline
|
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Home Meal Preparation
Ramy czasowe: 3 month
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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).
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3 month
|
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Home Meal Preparation
Ramy czasowe: 6 month
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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
|
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Home Meal Preparation
Ramy czasowe: 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).
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1 year follow up
|
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Cooking skills
Ramy czasowe: Baseline
|
The Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
Baseline
|
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Cooking skills
Ramy czasowe: 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
|
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Cooking skills
Ramy czasowe: 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
|
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Cooking skills
Ramy czasowe: 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
|
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Social support
Ramy czasowe: 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
|
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Social support
Ramy czasowe: 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
|
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Social support
Ramy czasowe: 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
Ramy czasowe: 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).
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1 year follow up
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 października 2026
Zakończenie podstawowe (Szacowany)
1 października 2030
Ukończenie studiów (Szacowany)
1 marca 2031
Daty rejestracji na studia
Pierwszy przesłany
29 czerwca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
6 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
7 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
2 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- STUDY00029380
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
There are no plans in order to maintain participant confidentiality.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .