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Clinical Trial NCT04445168 (EPPC) for PreDiabetes, Diabetes, Sedentary Behavior is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Randomized Trial of Exercise Promotion in Primary Care (EPPC)

Active, not recruiting
Clinical Trial NCT04445168 (EPPC) is an interventional study for PreDiabetes, Diabetes, Sedentary Behavior that is active, not recruiting. It started on 31 August 2020 with plans to enroll 451 participants. Led by Kaiser Permanente, it is expected to complete by 31 December 2025. The latest data from ClinicalTrials.gov was last updated on 24 March 2025.
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.
Official Title

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

Conditions
PrediabetesDiabetesSedentary Behavior
Other Study IDs
  • EPPC
  • KPSC IRB#10106M
NCT ID Number
NCT04445168
Start Date (Actual)
2020-08-31
Last Update Posted
2025-03-24
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
451
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Physical activity
Randomized trial
Primary care
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionUsual 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.
N/A
ExperimentalIntervention
Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.
Telephone-based Motivational Interviews
2-year telephone-based motivational interviews to increase physical activity.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Moderate to vigorous physical activity (MVPA)
Accelerometer-derived 7-day MVPA
12 months
Moderate to vigorous physical activity (MVPA)
Accelerometer-derived 7-day MVPA
24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Weight
Weight assessed from electronic medical records
12 months
Weight
Weight assessed from electronic medical records
24 months
Systolic blood pressure
Systolic blood pressure assessed from electronic medical records
12 months
Systolic blood pressure
Systolic blood pressure assessed from electronic medical records
24 months
Diastolic blood pressure
Diastolic blood pressure assessed from electronic medical records
12 months
Diastolic blood pressure
Diastolic blood pressure assessed from electronic medical records
24 months
HbA1c
HbA1c assessed from electronic medical records
12 months
HbA1c
HbA1c assessed from electronic medical records
24 months
Health-related quality of life
Assessed from the short form (SF-8) instrument; scale 0 - 100, higher is more favorable quality of life
12 months
Health-related quality of life
Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life
24 months
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

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,

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,
Kaiser Permanente logoKaiser Permanente
No contact data.
1 Study Locations in 1 Countries

California

Kaiser Permanente Southern California, Pasadena, California, 911010, United States