Randomized Trial of Exercise Promotion in Primary Care

Study Overview
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Brief Summary
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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.

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

Conditions
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PreDiabetes, Diabetes, Sedentary Behavior

Intervention / Treatment
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* Behavioral: Telephone-based motivational interviews


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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<br>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<br>* 2-year telephone-based motivational interviews to increase physical activity.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Randomized trial, Primary care