Exercise Promotion in Primary Care (EPPC)
Primary Purpose
Physical Activity, PreDiabetes, Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational interviewing telephone counseling
Sponsored by
About this trial
This is an interventional other trial for Physical Activity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telephone counseling
Usual care
Arm Description
Participants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03429088
Brief Title
Exercise Promotion in Primary Care
Acronym
EPPC
Official Title
Exercise Promotion in Primary Care: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, PreDiabetes, Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone counseling
Arm Type
Experimental
Arm Description
Participants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing telephone counseling
Primary Outcome Measure Information:
Title
Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention.
Description
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.
Time Frame
The intervention lasted 24 weeks.
Secondary Outcome Measure Information:
Title
Moderate to Vigorous Physical Activity
Description
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.
Time Frame
Assessments were made a baseline and approximately 24 weeks after baseline assessments.
Title
Motivation for Physical Activity
Description
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.
Time Frame
Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
Title
Physical Activity Self-Regulation
Description
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.
Time Frame
Participants completed the survey at baseline and approximately 24 weeks after baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30675373
Citation
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.
Results Reference
derived
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Exercise Promotion in Primary Care
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