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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
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Physical Activity

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 31, 2018
    Last Updated
    August 30, 2021
    Sponsor
    Kaiser Permanente
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    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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