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OpenTrials
Active, Not Recruiting

NCT Number: NCT04445168

Randomized Trial of Exercise Promotion in Primary Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

PreDiabetes Behavior Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Prediabetic State Sedentary Behavior

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Southern California

Pasadena, California, 911010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Telephone-based motivational interviews

Behavioral

2-year telephone-based motivational interviews to increase physical activity.

Primary outcomes

  1. Moderate to vigorous physical activity (MVPA)

    Time frame: 12 months

    Accelerometer-derived 7-day MVPA

  2. Moderate to vigorous physical activity (MVPA)

    Time frame: 24 months

    Accelerometer-derived 7-day MVPA

Secondary outcomes

  1. Weight

    Time frame: 12 months

    Weight assessed from electronic medical records

  2. Weight

    Time frame: 24 months

    Weight assessed from electronic medical records

  3. Systolic blood pressure

    Time frame: 12 months

    Systolic blood pressure assessed from electronic medical records

  4. Systolic blood pressure

    Time frame: 24 months

    Systolic blood pressure assessed from electronic medical records

  5. Diastolic blood pressure

    Time frame: 12 months

    Diastolic blood pressure assessed from electronic medical records

  6. Diastolic blood pressure

    Time frame: 24 months

    Diastolic blood pressure assessed from electronic medical records

  7. HbA1c

    Time frame: 12 months

    HbA1c assessed from electronic medical records

  8. HbA1c

    Time frame: 24 months

    HbA1c assessed from electronic medical records

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

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

Acronym: EPPC

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2020
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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