Exercise Promotion in Primary Care

Diabetes Clinical Trial

— EPPC  

Official title:

Exercise Promotion in Primary Care: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429088
• Other study ID #: KPSC IRB#10106
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: February 2018
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Physical Activity
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Motivational interviewing telephone counseling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.