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Physical Activity for Campus Employees (PACE)

19. maj 2015 opdateret af: Washington University School of Medicine
The aim of this pilot study is to evaluate the effects of a worksite wellness program on physical activity and cardiovascular disease risk factors among university employees. The investigators hypothesize that the proposed worksite wellness program will be effective for increasing daily physical activity and improving one or more cardiovascular disease risk factors among university employees.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

141

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63108
        • Washington University

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will consist of employees of Washington University in St. Louis. A convenience sample of staff employees located on the Danforth campus will be enrolled.

Beskrivelse

Inclusion Criteria:

  • employee of Washington University in St. Louis

Exclusion Criteria:

  • pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Daily Step Count (determined by pedometer)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body weight
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Susan B Racette, PhD, Washington University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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

1. januar 2012

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

6. juni 2012

Først indsendt, der opfyldte QC-kriterier

11. juni 2012

Først opslået (Skøn)

12. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2015

Sidst verificeret

1. maj 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201109022

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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