Physical ActivityEPPCNCT03429088
Exercise Promotion in Primary Care
A study testing Motivational interviewing telephone counseling in people with Physical Activity and PreDiabetes, run by Kaiser Permanente.
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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Physical Activity, PreDiabetes, Diabetes
- What is being tested?
- Motivational interviewing telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prediabetes or diabetes not prescribed insulin
- less than 30 min of physical activity per week
- cleared to increase physical activity by primary care provider
Who cannot join
- 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
About this study
Official title: Exercise Promotion in Primary Care: Pilot Study
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.
- Conditions
- Physical Activity, PreDiabetes, Diabetes
- Being tested
- Motivational interviewing telephone counseling
- Medical subject headings
- Motor Activity, Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing telephone counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Telephone counseling | Experimental | Participants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The intervention lasted 24 weeks.
Secondary outcomes (3)
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.
Measured: Assessments were made a baseline and approximately 24 weeks after baseline assessments.
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.
Measured: Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
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.
Measured: Participants completed the survey at baseline and approximately 24 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Jun 2015
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah R. Young, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429088
- Sponsor's protocol ID
- KPSC IRB#10106
- Acronym
- EPPC
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30675373
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Promotion in Primary Care: Pilot Study
- ClinicalTrials.gov ID
- NCT03429088
- Acronym / sponsor ID
- EPPC / KPSC IRB#10106
- Conditions
- Physical Activity, PreDiabetes, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone counseling | Experimental | Behavioral: Motivational interviewing telephone counselingParticipants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity. |
| 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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prediabetes or diabetes not prescribed insulin
- less than 30 min of physical activity per week
- cleared to increase physical activity by primary care provider
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing telephone counseling | Behavioural | Telephone counseling |
Primary outcome
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.
3 secondary outcomes
Moderate to Vigorous Physical Activity
Time frame: Assessments were made a baseline and approximately 24 weeks after baseline assessments.
Motivation for Physical Activity
Time frame: Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
Physical Activity Self-Regulation
Time frame: Participants completed the survey at baseline and approximately 24 weeks after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 30675373Young 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing telephone counseling in people with Physical Activity and PreDiabetes, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention. (time frame: The intervention lasted 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.