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Primary Care-Based Physical Activity for Diabetic Latinas

9. Januar 2020 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

25

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • La Jolla, California, Vereinigte Staaten, 92093-0628
        • University of California, San Diego

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: Tailored Physical Activity Intervention
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.
Andere Namen:
  • Camino a La Salud
Aktiver 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.
Verhalten: Standard of Care
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective Changes in Physical Activity from Baseline to 6 Months
Zeitfenster: Baseline, 6 Months (MO)
The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from baseline to 6 months.
Baseline, 6 Months (MO)
Self-Report Changes in Physical Activity from Baseline to 6 Months
Zeitfenster: Baseline, 6 Months (MO)
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.
Baseline, 6 Months (MO)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Objective Changes in Physical Activity from 6 Months to 12 Months
Zeitfenster: 6 Months (MO), 12 Months (MO)
The ActiGraph GT3X+ accelerometer will be the primary measure to assess objective changes in physical activity from 6 to 12 months.
6 Months (MO), 12 Months (MO)
Self-Report Changes in Physical Activity from 6 Months to 12 Months
Zeitfenster: 6 Months (MO), 12 Months (MO)
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.
6 Months (MO), 12 Months (MO)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Diego

Ermittler

  • Hauptermittler: Britta Larsen, PhD, UC, San Diego Department of Family Medicine and Public Health

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2016

Primärer Abschluss (Tatsächlich)

1. Oktober 2019

Studienabschluss (Tatsächlich)

1. Oktober 2019

Studienanmeldedaten

Zuerst eingereicht

5. April 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. April 2016

Zuerst gepostet (Schätzen)

18. April 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Januar 2020

Zuletzt verifiziert

1. Januar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • K01DK101650 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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