Randomized Trial of Exercise Promotion in Primary Care (EPPC)

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: Recruiting
• Conditions: Diabetes; PreDiabetes; Sedentary Behavior
• Intervention / Treatment: Behavioral: Telephone-based motivational interviews

• Study Type: Interventional
• Enrollment (Anticipated): 780
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah R Young, PhD; Phone Number: 626-564-3887; Email: deborah.r.young@kp.org
• Study Contact Backup: Name: Melissa Preciado, MPH; Phone Number: 626-564-3000; Email: melissa.x.preciado@kp.org

Study Locations

• United States
  • California
    • Pasadena, California, United States, 911010
      • Recruiting
      • Kaiser Permanente Southern California
      • Contact: Deborah R Young, PhD; Phone Number: 626-564-3887; Email: deborah.r.young@kp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	Accelerometer-derived 7-day MVPA	12 months
Moderate to vigorous physical activity (MVPA)	Accelerometer-derived 7-day MVPA	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

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): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Primary care; Physical activity; Randomized trial
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• 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