Randomized Trial of Exercise Promotion in Primary Care (EPPC)

March 19, 2025 updated by: Kaiser Permanente

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: Intervention
Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.
Behavioral: Telephone-based motivational interviews
2-year telephone-based motivational interviews to increase physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate to vigorous physical activity (MVPA)
Time Frame: 12 months
Accelerometer-derived 7-day MVPA
12 months
Moderate to vigorous physical activity (MVPA)
Time Frame: 24 months
Accelerometer-derived 7-day MVPA
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 12 months
Weight assessed from electronic medical records
12 months
Weight
Time Frame: 24 months
Weight assessed from electronic medical records
24 months
Systolic blood pressure
Time Frame: 12 months
Systolic blood pressure assessed from electronic medical records
12 months
Systolic blood pressure
Time Frame: 24 months
Systolic blood pressure assessed from electronic medical records
24 months
Diastolic blood pressure
Time Frame: 12 months
Diastolic blood pressure assessed from electronic medical records
12 months
Diastolic blood pressure
Time Frame: 24 months
Diastolic blood pressure assessed from electronic medical records
24 months
HbA1c
Time Frame: 12 months
HbA1c assessed from electronic medical records
12 months
HbA1c
Time Frame: 24 months
HbA1c assessed from electronic medical records
24 months
Health-related quality of life
Time Frame: 12 months
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
Time Frame: 24 months
Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KPSC IRB#10106M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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