- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01617499
Physical Activity for Campus Employees (PACE)
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Cardiovascular disease (CVD) persists as the leading cause of mortality in the United States and accounts for 17 percent of the nation's overall health expenditures. Although the mortality rate of CVD has declined in recent years, the burden of disease remains high. Currently, 1 in 3 Americans has some form of CVD. Additionally, according to a recent policy statement published by the American Heart Association (AHA), 40% of the population is projected to have some form of CVD by 2030. Furthermore, the AHA has projected that the cost to treat CVD will triple by 2030. The prevalence and rising financial burden of CVD demonstrate the urgency for effective implementation of disease prevention strategies.
Evidence suggesting the majority of CVD is preventable through modifiable risk factor management continues to grow. Nonetheless, difficulty controlling modifiable risk factors remains an issue for many Americans. The magnitude of this challenge is supported by a study revealing that 78% of adults are candidates for at least one CVD prevention activity. Although national organizations have published a variety of disease prevention recommendations, widespread implementation of and adherence to preventative programs remain problematic. Consequently, a large proportion of the population is not receiving or participating in prevention strategies from which they may benefit. The full potential of reducing the nation's CVD burden cannot be achieved unless interventions are implemented on a larger scale, with reduced costs, and with increased initial and continued participation.
With approximately 130 million Americans currently employed, workplaces provide ideal environments for implementation of sizable, cost-effective CVD prevention programs. However, successful wellness programming remains a laborious, resource intensive challenge for employers. In 2004, a National Worksite Health Promotion Survey disclosed that less than 7% of U.S. employers offered worksite wellness programs. Furthermore, an estimated 25-30% of companies' annual medical costs are spent on employees with CVD risk factors.
In the proposed study, a worksite wellness program that includes health assessments, personal health reports, and pedometer-based tracking of physical activity will be offered to university employees. Participants will not be randomized to an intervention or control group. Rather, program components will be available to all enrolled participants, and each individual may choose whether to wear a pedometer, track their step counts, attend wellness sessions, and/or complete the health assessments. There is no prescribed intervention. Wellness sessions include educational information on lifestyle behaviors to promote cardiometabolic health.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Missouri
-
St. Louis, Missouri, Stany Zjednoczone, 63108
- Washington University
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- employee of Washington University in St. Louis
Exclusion Criteria:
- pregnancy
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
---|---|
University employees
Participants will include employees of Washington University in St. Louis.
Recruitment will be directed to staff employees of the Central Fiscal Unit (CFU) on the Danforth campus.
|
The worksite wellness program included cardiovascular health assessments, personal health reports, 8 weeks of pedometer-based walking and tracking activities, and weekly wellness sessions.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Daily Step Count (determined by pedometer)
Ramy czasowe: Baseline, week 4, and week 8
|
Daily step counts, as recorded by pedometers, will be self-reported by participants for 7 continuous days at 3 study time points: baseline, week 4, and week 8.
|
Baseline, week 4, and week 8
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Body weight
Ramy czasowe: Baseline and week 9
|
Body weight will be measured on a digital scale in the morning after an overnight fast.
Shoes, jewelry, sweaters, jackets, belts, and hats will be removed and pockets will be emptied before the measurement is made.
|
Baseline and week 9
|
Body Mass Index (BMI)
Ramy czasowe: Baseline and week 9
|
BMI will be computed as weight in kilograms divided by height in meters squared.
Weight Status will be determined using standard CDC BMI categories.
|
Baseline and week 9
|
Body Composition
Ramy czasowe: Baseline and week 9
|
Fat mass (kg), fat free mass (kg), and percentage body fat will be determined by bioelectrical impedance analysis using the InBody 520 analyzer.
|
Baseline and week 9
|
waist circumference
Ramy czasowe: Baseline and week 9
|
Waist circumference will be measured at the border of the iliac crest using a Gulick II tape measure.
|
Baseline and week 9
|
Blood Pressure
Ramy czasowe: Baseline and week 9
|
Systolic and diastolic blood pressure will be measured in duplicate in the right arm after 10 minutes of seated rest using the Omron HEM-907XL Professional Digital Blood Pressure Monitors (Omron Healthcare, Kyoto, Japan).
One minute rest will be provided between the 2 measurements.
|
Baseline and week 9
|
Fasting plasma glucose
Ramy czasowe: Baseline and week 9
|
Fasting plasma glucose will be measured from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
|
Baseline and week 9
|
Total Cholesterol
Ramy czasowe: Baseline and week 9
|
Total cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
|
Baseline and week 9
|
LDL Cholesterol
Ramy czasowe: Baseline and week 9
|
LDL cholesterol will be computed using the Friedewald equation from the lipid profile measured from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
|
Baseline and week 9
|
HDL Cholesterol
Ramy czasowe: Baseline and week 9
|
HDL cholesterol will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
|
Baseline and week 9
|
Triglycerides
Ramy czasowe: Baseline and week 9
|
Triglycerides will be quantified from a fingerstick blood sample in the morning after an overnight fast using the Cholestech LDX System® (Hayward, CA).
|
Baseline and week 9
|
Non-HDL Cholesterol
Ramy czasowe: Baseline and week 9
|
Non-HDL cholesterol will be computed by difference based on the lipid profile determined from a fasted fingerstick blood sample using the Cholestech LDX System® (Hayward, CA).
|
Baseline and week 9
|
Resting heart rate
Ramy czasowe: Baseline and week 9
|
Resting heart rate will be measured in duplicate in the morning after 10 minutes of seated rest using Omron HEM-907XL Professional Digital Blood Pressure Monitors (Omron Healthcare, Kyoto, Japan).
|
Baseline and week 9
|
Cardiorespiratory fitness based on post-exercise recovery heart rate
Ramy czasowe: Baseline and week 9
|
Cardiorespiratory fitness will be estimated based on heart rate recovery following a 3-minute step test performed with an 8-inch step and a metronome set to 96 beats/minute.
Participants will be instructed to maintain the pace set by the beat of the metronome for 3 consecutive minutes and to be seated immediately at the completion of the 3-minute test.
The subject's right radial pulse rate will be measured for 30 seconds, beginning 30 seconds after the completion of the test.
Cardiorespiratory fitness level will be computed based on sex- and age-specific heart rate criteria.
|
Baseline and week 9
|
Dietary patterns
Ramy czasowe: Baseline and week 9
|
Dietary patterns will be assessed using the nutrition questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).
|
Baseline and week 9
|
Physical activity patterns
Ramy czasowe: Baseline and week 9
|
Physical activity patterns will be assessed using the exercise questions from the CDC Behavioral Risk Factor Surveillance System (BRFSS).
|
Baseline and week 9
|
Perceived barriers to exercise participation
Ramy czasowe: Baseline and week 9
|
Perceived barriers to exercise participation will be assessed using the "Exercise Barriers" questionnaire, which the subject will complete on his/her own.
|
Baseline and week 9
|
Perceived benefits of exercise
Ramy czasowe: Baseline and week 9
|
Perceived benefits of exercise will be assessed using the "Exercise Benefits" questionnaire, which the subject will complete on his/her own.
|
Baseline and week 9
|
Participant evaluation of the wellness program
Ramy czasowe: Weeks 12 - 14
|
Participants will be asked to provide feedback about the wellness program through a 10-question, anonymous, online survey administered using the web-based Survey Monkey tool.
|
Weeks 12 - 14
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Susan B Racette, PhD, Washington University School of Medicine
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 201109022
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 .
Badania kliniczne na Choroby układu krążenia
-
Bambino Gesù Hospital and Research InstituteZakończonyCiężka otyłość dziecięca (BMI > 97° szt. -według wykresów BMI Centers for Disease Control and Prevention-) | Zmienione testy czynnościowe wątroby | Nietolerancja glikemicznaWłochy
-
Spero TherapeuticsZakończonyKompleks Mycobacterium Avium | Niegruźlicze Mycobacterium Pulmonary DiseaseStany Zjednoczone
-
Janssen Pharmaceutical K.K.RekrutacyjnyOporna na leczenie Mycobacterium Avium Complex-lung Disease (MAC-LD)Tajwan, Republika Korei, Japonia
-
Adelphi Values LLCBlueprint Medicines CorporationZakończonyBiałaczka z komórek tucznych (MCL) | Agresywna mastocytoza układowa (ASM) | SM w Assoc Clonal Hema Lineage Non-mast Cell Lineage Disease (SM-AHNMD) | Tląca się mastocytoza układowa (SSM) | Indolentna układowa mastocytoza (ISM) Podgrupa ISM w pełni zatrudnionaStany Zjednoczone
Badania kliniczne na Physical activity
-
Duke UniversityRejestracja na zaproszenieDługi COVID | Długi Covid19 | Długi Covid-19Stany Zjednoczone
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI); University of Rochester; University of Massachusetts...ZakończonyRak piersi | Ocalona od raka piersi | Monitory kondycjiStany Zjednoczone
-
Massachusetts General HospitalAktywny, nie rekrutującyŁysienie czołowe włókniące | Liszaj planopilaris | Liszaj planopilaris skóry głowy | Licheń Plano-PilarisStany Zjednoczone
-
St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences OrganizationZakończony
-
Duke UniversityRejestracja na zaproszenieDługi COVID | Długi Covid19 | Długi Covid-19Stany Zjednoczone
-
Norwegian University of Science and TechnologyZakończonyChoroby układu krążenia | OtyłośćNorwegia
-
Norwegian University of Science and TechnologyLHL HelseZakończony