NCT03429088

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
Last Updated

September 1, 2021

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

January 31, 2018

Last Update Submit

August 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Moderate to Vigorous Physical Activity

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

  • Motivation for Physical Activity

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

  • Physical Activity Self-Regulation

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

Study Arms (2)

Telephone counseling

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor ActivityPrediabetic StateDiabetes Mellitus

Condition Hierarchy (Ancestors)

BehaviorGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist III

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 12, 2018

Study Start

June 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 1, 2021

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share