Randomized Trial of Exercise Promotion in Primary Care

Diabetes Clinical Trial

— EPPC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04445168
• Other study ID #: KPSC IRB#10106M
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2021
• Source: Kaiser Permanente
• Contact: Deborah R Young, PhD
• Phone: 626-564-3887
• Email: deborah.r.young[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 780
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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,

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance
• PreDiabetes
• Prediabetic State
• Sedentary Behavior

Intervention

Behavioral:
• Telephone-based motivational interviews
2-year telephone-based motivational interviews to increase physical activity.

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate to vigorous physical activity (MVPA)	Accelerometer-derived 7-day MVPA	12 months
Primary	Moderate to vigorous physical activity (MVPA)	Accelerometer-derived 7-day MVPA	24 months
Secondary	Weight	Weight assessed from electronic medical records	12 months
Secondary	Weight	Weight assessed from electronic medical records	24 months
Secondary	Systolic blood pressure	Systolic blood pressure assessed from electronic medical records	12 months
Secondary	Systolic blood pressure	Systolic blood pressure assessed from electronic medical records	24 months
Secondary	Diastolic blood pressure	Diastolic blood pressure assessed from electronic medical records	12 months
Secondary	Diastolic blood pressure	Diastolic blood pressure assessed from electronic medical records	24 months
Secondary	HbA1c	HbA1c assessed from electronic medical records	12 months
Secondary	HbA1c	HbA1c assessed from electronic medical records	24 months
Secondary	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
Secondary	Health-related quality of life	Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life	24 months