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Clinical Trials/NCT04445168
NCT04445168
Active, not recruiting
Not Applicable

Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes

Kaiser Permanente1 site in 1 country451 target enrollmentAugust 31, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PreDiabetes
Sponsor
Kaiser Permanente
Enrollment
451
Locations
1
Primary Endpoint
Moderate to vigorous physical activity (MVPA)
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.

Registry
clinicaltrials.gov
Start Date
August 31, 2020
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,

Exclusion Criteria

  • Current use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,

Outcomes

Primary Outcomes

Moderate to vigorous physical activity (MVPA)

Time Frame: 24 months

Accelerometer-derived 7-day MVPA

Secondary Outcomes

  • Health-related quality of life(24 months)
  • Weight(24 months)
  • HbA1c(24 months)
  • Systolic blood pressure(24 months)
  • Diastolic blood pressure(24 months)

Study Sites (1)

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