- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03429088
Exercise Promotion in Primary Care (EPPC)
30. august 2021 opdateret af: Deborah R. Young, Kaiser Permanente
Exercise Promotion in Primary Care: Pilot Study
The investigators conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses physical activity of its members, is a feasible approach to improve physical activity among patients with diabetes and prediabetes.
The investigators built on an existing innovation at Kaiser Permanente, in which physical activity is assessed at every outpatient visit.
The primary aims were to (1) pilot study elements, including database identification of patients; recruitment, training and engagement of health care providers; patient recruitment; data collection procedures; and a 24-week intervention, and (2) to assess feasibility and obtain feedback from key stakeholders on the approach.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
67
Fase
- Ikke anvendelig
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 til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- prediabetes or diabetes not prescribed insulin
- less than 30 min of physical activity per week
- cleared to increase physical activity by primary care provider
Exclusion Criteria:
- health condition that may limit unsupervised physical activity
- height and weight that were combined and resulted in a BMI > 40 kg/m2
- disabling rheumatoid or osteoarthritis
- ongoing treatment for cancer
- unstable coronary heart disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Telephone counseling
Participants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity.
|
|
Ingen indgriben: Usual care
Participants in the usual care arm received a packet of places near their home in which they could engage in physical activity if they chose.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention.
Tidsramme: The intervention lasted 24 weeks.
|
Participants who met eligibility criteria and who were scheduled for an outpatient visit with their primary care provider were invited to participate in the study.
Feasibility was assessed by the investigators' ability to recruit 60 participants into the pilot trial.
|
The intervention lasted 24 weeks.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Moderate to Vigorous Physical Activity
Tidsramme: Assessments were made a baseline and approximately 24 weeks after baseline assessments.
|
Participants were mailed an Actigraph model 7185 accelerometer and asked to wear it over their right hip for 7 consecutive days and return the monitor through the mail.
Data were analyzed to assess daily moderate to vigorous physical activity using the Freedson cutpoints.
|
Assessments were made a baseline and approximately 24 weeks after baseline assessments.
|
Motivation for Physical Activity
Tidsramme: Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
|
The 30-item Motivation for Physical Activities Measure was used to measure motivation for physical activity.
The scale has 5 factors: interest/enjoyment, competence, appearance, fitness, and social motivations.
A mean score for each factor was determined for each participant.
|
Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
|
Physical Activity Self-Regulation
Tidsramme: Participants completed the survey at baseline and approximately 24 weeks after baseline.
|
This is a 16-item scale with the following factors: external regulation, introjected regulation, identified regulation, and intrinsic regulation.
A Relative Autonomy Index is formed from the factors, with the higher scores indicating greater autonomy toward physical activity.
|
Participants completed the survey at baseline and approximately 24 weeks after baseline.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
1. juni 2015
Primær færdiggørelse (Faktiske)
1. juli 2017
Studieafslutning (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først indsendt
31. januar 2018
Først indsendt, der opfyldte QC-kriterier
5. februar 2018
Først opslået (Faktiske)
12. februar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2021
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KPSC IRB#10106
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .
Kliniske forsøg med Motivational interviewing telephone counseling
-
Northwell HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetAlkohol drikke | Alkoholisme | Alkohol-relaterede lidelser | Alkoholbrugsforstyrrelser | Alkohol misbrugForenede Stater
-
University of VermontAfrica Mental Health FoundationAfsluttetAlkoholbrugsforstyrrelse
-
University of MiamiAB InBev FoundationAfsluttet
-
Florida State UniversityJohns Hopkins University; Children's Hospital of Philadelphia; University... og andre samarbejdspartnereAfsluttetHIV-infektioner | Ungdomsudvikling | Plejefremkaldende adfærd | Patient manglende overholdelse | Patient afslag på behandlingForenede Stater