Randomized Trial of Exercise Promotion in Primary Care

Not Applicable

Active, not recruiting

• Conditions: PreDiabetes; Diabetes; Sedentary Behavior
• Interventions: Behavioral: Telephone-based motivational interviews

• Registration Number: NCT04445168
• Lead Sponsor: Kaiser Permanente

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-08-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 451

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Telephone-based motivational interviews	Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity.

Primary Outcome Measures

Name	Time	Method
Moderate to vigorous physical activity (MVPA)	24 months	Accelerometer-derived 7-day MVPA

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kaiser Permanente Southern California; 🇺🇸 Pasadena, California, United States