Exercise Promotion in Primary Care (EPPC)

Exercise Promotion in Primary Care: Pilot Study

The investigators conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses physical activity of its members, is a feasible approach to improve physical activity among patients with diabetes and prediabetes. The investigators built on an existing innovation at Kaiser Permanente, in which physical activity is assessed at every outpatient visit. The primary aims were to (1) pilot study elements, including database identification of patients; recruitment, training and engagement of health care providers; patient recruitment; data collection procedures; and a 24-week intervention, and (2) to assess feasibility and obtain feedback from key stakeholders on the approach.

Study Overview

• Status: Completed
• Conditions: Diabetes; Physical Activity; PreDiabetes
• Intervention / Treatment: Behavioral: Motivational interviewing telephone counseling

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• prediabetes or diabetes not prescribed insulin
• less than 30 min of physical activity per week
• cleared to increase physical activity by primary care provider

Exclusion Criteria:

• health condition that may limit unsupervised physical activity
• height and weight that were combined and resulted in a BMI > 40 kg/m2
• disabling rheumatoid or osteoarthritis
• ongoing treatment for cancer
• unstable coronary heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephone counseling; Participants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity.	Behavioral: Motivational interviewing telephone counseling
No Intervention: Usual care; Participants in the usual care arm received a packet of places near their home in which they could engage in physical activity if they chose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention.	Participants who met eligibility criteria and who were scheduled for an outpatient visit with their primary care provider were invited to participate in the study. Feasibility was assessed by the investigators' ability to recruit 60 participants into the pilot trial.	The intervention lasted 24 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderate to Vigorous Physical Activity	Participants were mailed an Actigraph model 7185 accelerometer and asked to wear it over their right hip for 7 consecutive days and return the monitor through the mail. Data were analyzed to assess daily moderate to vigorous physical activity using the Freedson cutpoints.	Assessments were made a baseline and approximately 24 weeks after baseline assessments.
Motivation for Physical Activity	The 30-item Motivation for Physical Activities Measure was used to measure motivation for physical activity. The scale has 5 factors: interest/enjoyment, competence, appearance, fitness, and social motivations. A mean score for each factor was determined for each participant.	Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
Physical Activity Self-Regulation	This is a 16-item scale with the following factors: external regulation, introjected regulation, identified regulation, and intrinsic regulation. A Relative Autonomy Index is formed from the factors, with the higher scores indicating greater autonomy toward physical activity.	Participants completed the survey at baseline and approximately 24 weeks after baseline.

Collaborators and Investigators

• Sponsor: Kaiser Permanente

Publications and helpful links

General Publications

• Young DR, Nguyen MK, Yamamoto A, Pomichowski M, Cornejo M, Paz S, Coleman KJ, Sallis RE, Fortmann SP. Telephone-based motivational interviewing versus usual care in primary care to increase physical activity: a randomized pilot study. Pilot Feasibility Stud. 2019 Jan 15;5:6. doi: 10.1186/s40814-019-0390-0. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: KPSC IRB#10106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No