Randomized Trial of Exercise Promotion in Primary Care

NCT ID: NCT04445168

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 451 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2025-12-31

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.

Conditions

PreDiabetes; Diabetes; Sedentary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: EXPERIMENTAL

Telephone-based motivational interviews

Intervention Type: BEHAVIORAL

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

Interventions

Telephone-based motivational interviews

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaiser Permanente Southern California

Pasadena, California, United States

Countries

United States

Other Identifiers

KPSC IRB#10106M

Identifier Type: -

Identifier Source: org_study_id