Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Kaiser Permanente
- Enrollment
- 451
- Locations
- 1
- Primary Endpoint
- Moderate to vigorous physical activity (MVPA)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Arms & Interventions
Usual Care
Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics.
Intervention
Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.
Intervention: Telephone-based motivational interviews (Behavioral)
Outcomes
Primary Outcomes
Moderate to vigorous physical activity (MVPA)
Time Frame: 24 months
Accelerometer-derived 7-day MVPA
Moderate to vigorous physical activity (MVPA)
Time Frame: 12 months
Accelerometer-derived 7-day MVPA
Secondary Outcomes
- Weight(24 months)
- HbA1c(24 months)
- Systolic blood pressure(24 months)
- Health-related quality of life(24 months)
- Diastolic blood pressure(24 months)
- Weight(12 months)
- Systolic blood pressure(12 months)
- Diastolic blood pressure(12 months)
- HbA1c(12 months)
- Health-related quality of life(12 months)