Back to resultsRandomized Trial of Exercise Promotion in Primary Care (EPPC)
Primary Purpose
PreDiabetes, Diabetes, Sedentary Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-based motivational interviews
Sponsored by
About this trial
This is an interventional prevention trial for PreDiabetes focused on measuring Physical activity, Randomized trial, Primary care
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,
Sites / Locations
- Kaiser Permanente Southern CaliforniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Intervention
Arm Description
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.
Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.
Outcomes
Primary Outcome Measures
Moderate to vigorous physical activity (MVPA)
Accelerometer-derived 7-day MVPA
Moderate to vigorous physical activity (MVPA)
Accelerometer-derived 7-day MVPA
Secondary Outcome Measures
Weight
Weight assessed from electronic medical records
Weight
Weight assessed from electronic medical records
Systolic blood pressure
Systolic blood pressure assessed from electronic medical records
Systolic blood pressure
Systolic blood pressure assessed from electronic medical records
Diastolic blood pressure
Diastolic blood pressure assessed from electronic medical records
Diastolic blood pressure
Diastolic blood pressure assessed from electronic medical records
HbA1c
HbA1c assessed from electronic medical records
HbA1c
HbA1c assessed from electronic medical records
Health-related quality of life
Assessed from the short form (SF-8) instrument; scale 0 - 100, higher is more favorable quality of life
Health-related quality of life
Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04445168
Brief Title
Randomized Trial of Exercise Promotion in Primary Care
Acronym
EPPC
Official Title
Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Diabetes, Sedentary Behavior
Keywords
Physical activity, Randomized trial, Primary care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
780 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based motivational interviews
Intervention Description
2-year telephone-based motivational interviews to increase physical activity.
Primary Outcome Measure Information:
Title
Moderate to vigorous physical activity (MVPA)
Description
Accelerometer-derived 7-day MVPA
Time Frame
12 months
Title
Moderate to vigorous physical activity (MVPA)
Description
Accelerometer-derived 7-day MVPA
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Weight
Description
Weight assessed from electronic medical records
Time Frame
12 months
Title
Weight
Description
Weight assessed from electronic medical records
Time Frame
24 months
Title
Systolic blood pressure
Description
Systolic blood pressure assessed from electronic medical records
Time Frame
12 months
Title
Systolic blood pressure
Description
Systolic blood pressure assessed from electronic medical records
Time Frame
24 months
Title
Diastolic blood pressure
Description
Diastolic blood pressure assessed from electronic medical records
Time Frame
12 months
Title
Diastolic blood pressure
Description
Diastolic blood pressure assessed from electronic medical records
Time Frame
24 months
Title
HbA1c
Description
HbA1c assessed from electronic medical records
Time Frame
12 months
Title
HbA1c
Description
HbA1c assessed from electronic medical records
Time Frame
24 months
Title
Health-related quality of life
Description
Assessed from the short form (SF-8) instrument; scale 0 - 100, higher is more favorable quality of life
Time Frame
12 months
Title
Health-related quality of life
Description
Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah R Young, PhD
Phone
626-564-3887
Email
deborah.r.young@kp.org
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Preciado, MPH
Phone
626-564-3000
Email
melissa.x.preciado@kp.org
Facility Information:
Facility Name
Kaiser Permanente Southern California
City
Pasadena
State/Province
California
ZIP/Postal Code
911010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah R Young, PhD
Phone
626-564-3887
Email
deborah.r.young@kp.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Randomized Trial of Exercise Promotion in Primary Care
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