Randomized Trial of Exercise Promotion in Primary Care

N/AActive Not RecruitingNCT04445168

Kaiser Permanente451 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

451

Conditions

PreDiabetes Diabetes Sedentary Behavior

Interventions

Telephone-based motivational interviewsBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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,

Locations (1)

Kaiser Permanente Southern California

Pasadena, California, United States

Outcomes

Primary Outcomes

Moderate to vigorous physical activity (MVPA)

Accelerometer-derived 7-day MVPA

Time frame: 12 months

Moderate to vigorous physical activity (MVPA)

Accelerometer-derived 7-day MVPA

Time frame: 24 months

Secondary Outcomes

Weight

Weight assessed from electronic medical records

Time frame: 12 months

Weight

Weight assessed from electronic medical records

Time frame: 24 months

Systolic blood pressure

Systolic blood pressure assessed from electronic medical records

Time frame: 12 months

Systolic blood pressure

Systolic blood pressure assessed from electronic medical records

Time frame: 24 months

Diastolic blood pressure

Diastolic blood pressure assessed from electronic medical records

Time frame: 12 months

Diastolic blood pressure

Diastolic blood pressure assessed from electronic medical records

Time frame: 24 months

HbA1c

HbA1c assessed from electronic medical records

Time frame: 12 months

Data from ClinicalTrials.gov

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