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OpenTrials
Completed

NCT Number: NCT03429088

Exercise Promotion in Primary Care

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motivational interviewing telephone counseling

Behavioral

Primary outcomes

  1. Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention.

    Time frame: The intervention lasted 24 weeks.

    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 outcomes

  1. Moderate to Vigorous Physical Activity

    Time frame: Assessments were made a baseline and approximately 24 weeks after baseline assessments.

    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.

  2. Motivation for Physical Activity

    Time frame: Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.

    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.

  3. Physical Activity Self-Regulation

    Time frame: Participants completed the survey at baseline and approximately 24 weeks after baseline.

    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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Exercise Promotion in Primary Care: Pilot Study

Acronym: EPPC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2018
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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