- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02741050
Primary Care-Based Physical Activity for Diabetic Latinas
9. januar 2020 oppdatert av: Britta Larsen, University of California, San Diego
Camino a La Salud: Adapting and Testing a Primary Care-Delivered Physical Activity Intervention for Latinas With Type II Diabetes
The goal of this proposal is to test the efficacy of a primary care-delivered, print-based physical activity intervention for Latinas with type II diabetes.
The investigators will test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited through UCSD Health System primary care to either the adapted web-based physical activity intervention or standard of care, and assessing physical activity gains at six and 12 months.
The ultimate goal is to develop a print-based physical activity intervention for diabetic Latinas that could be widely disseminated through primary care.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studies show that adoption of regular physical activity (PA) can greatly enhance diabetes management and prevention.
Individuals who adopt a PA routine show significant improvements in clinical markers of diabetes, including HbA1c, glucose tolerance, insulin sensitivity, weight and waist circumference, and significant reductions in medication use, and also show reductions in cardiovascular risk factors and other related co-morbidities.
Incorporation of cost-effective PA interventions into primary care for diabetes treatment could therefore enhance overall health and quality of life and significantly reduce healthcare costs.
The primary aim of this study is to conduct a small randomized trial (N=80) to test the efficacy of an individually tailored culturally adapted print-based physical activity intervention integrated into primary care to increase weekly moderate-to-vigorous physical activity in Latinas with type II diabetes, compared to those receiving standard of care.
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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La Jolla, California, Forente stater, 92093-0628
- University of California, San Diego
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Have received a physician's diagnosis of type II diabetes and are currently being seen by a primary care physician
- Currently inactive, defined as participating in at least moderate intensity physical activity for less than 60 minutes per week
Exclusion Criteria:
- Medical condition that may make exercise unsafe, including congestive heart failure, severe musculoskeletal problems or pulmonary conditions, or other conditions determined by the referring physician to preclude unsupervised exercise
- Unable to receive mailed materials (do not have a mailing address)
- Unable to engage in physical activity for at least 30 minutes
- Have a current or planned pregnancy
- Planning to move from the area within the next year
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Tailored Physical Activity Intervention
Intervention group will receive Spanish-language physical activity print intervention based on SCT and Transtheoretical Model, (TTM) that emphasizes behavioral strategies for increasing activity levels.
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The Tailored Internet intervention is based on constructs of the Transtheoretical Model (TTM) and Social Cognitive Theory (SCT).
During the 6-month intervention period, participants will receive monthly mailed questionnaires that assess current motivational readiness for physical activity and other TTM and SCT constructs (e.g., process of change, self-efficacy) and monthly logs to record their current activity.
Andre navn:
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Aktiv komparator: Standard of Care Control Group
Control group will receive standard of care through the Family Medicine clinic as well as monthly questionnaires on topics other than physical activity (e.g.
diet) to complete.
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Those assigned to the control group will continue to receive standard of care through the Family Medicine clinic.
This currently entails commonly accepted medication treatment strategies, educational materials and counseling for self-management and medication adherence, screening for depression or other conditions that would impair self-management, and national and state quality of care guidelines for lab testing and control targets (HbA1c, lipids, blood pressure).
Participants in the control group will also receive monthly questionnaires on topics other than physical activity (e.g.
diet) to fill out and return in order to have the same opportunities for compensation as those in the intervention condition.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Objective Changes in Physical Activity from Baseline to 6 Months
Tidsramme: Baseline, 6 Months (MO)
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The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months.
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Baseline, 6 Months (MO)
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Self-Report Changes in Physical Activity from Baseline to 6 Months
Tidsramme: Baseline, 6 Months (MO)
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The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from baseline to 6 months.
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities.
The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
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Baseline, 6 Months (MO)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Objective Changes in Physical Activity from 6 Months to 12 Months
Tidsramme: 6 Months (MO), 12 Months (MO)
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The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from 6 to 12 months.
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6 Months (MO), 12 Months (MO)
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Self-Report Changes in Physical Activity from 6 Months to 12 Months
Tidsramme: 6 Months (MO), 12 Months (MO)
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The 7-Day Physical Activity Recall (PAR) will also assess self-reported changes in physical activity from 6 to 12 months.
The 7-Day PAR is an interviewer administered instrument that uses multiple strategies for increasing accuracy of participant recall regarding many types of activities such as time spent sleeping and moderate, hard, and very hard intensity activities.
The 7-Day PAR is used across many studies assessing physical activity and has consistently demonstrated acceptable reliability, internal consistency, and congruent validity with other objective measures of activity levels.
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6 Months (MO), 12 Months (MO)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Britta Larsen, PhD, UC, San Diego Department of Family Medicine and Public Health
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. august 2016
Primær fullføring (Faktiske)
1. oktober 2019
Studiet fullført (Faktiske)
1. oktober 2019
Datoer for studieregistrering
Først innsendt
5. april 2016
Først innsendt som oppfylte QC-kriteriene
12. april 2016
Først lagt ut (Anslag)
18. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- K01DK101650 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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