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Primary Care-Based Physical Activity for Diabetic Latinas

9 januari 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

25

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • La Jolla, California, Verenigde Staten, 92093-0628
        • University of California, San Diego

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Changes in Physical Activity from Baseline to 6 Months
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Changes in Physical Activity from 6 Months to 12 Months
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Diego

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2016

Primaire voltooiing (Werkelijk)

1 oktober 2019

Studie voltooiing (Werkelijk)

1 oktober 2019

Studieregistratiedata

Eerst ingediend

5 april 2016

Eerst ingediend dat voldeed aan de QC-criteria

12 april 2016

Eerst geplaatst (Schatting)

18 april 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 januari 2020

Laatste update ingediend die voldeed aan QC-criteria

9 januari 2020

Laatst geverifieerd

1 januari 2020

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • K01DK101650 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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