PreDiabetesEPPCNCT04445168
Randomized Trial of Exercise Promotion in Primary Care
A study testing Telephone-based motivational interviews in people with PreDiabetes and Diabetes, run by Kaiser Permanente at 1 site in United States.
Trial summary
Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- PreDiabetes, Diabetes, Sedentary Behavior
- What is being tested?
- Telephone-based motivational interviews
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,
Who cannot join
- Current use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 911010
About this study
Official title: Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes
Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.
- Conditions
- PreDiabetes, Diabetes, Sedentary Behavior
- Being tested
- Telephone-based motivational interviews
- Keywords
- Physical activity, Randomized trial, Primary care
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based motivational interviewsBehavioural
2-year telephone-based motivational interviews to increase physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics. |
| Intervention | Experimental | Participants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity. Receives: Behavioral: Telephone-based motivational interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate to vigorous physical activity (MVPA)
Accelerometer-derived 7-day MVPA
Measured: 12 months
Moderate to vigorous physical activity (MVPA)
Accelerometer-derived 7-day MVPA
Measured: 24 months
Secondary outcomes (10)
Weight
Weight assessed from electronic medical records
Measured: 12 months
Weight
Weight assessed from electronic medical records
Measured: 24 months
Systolic blood pressure
Systolic blood pressure assessed from electronic medical records
Measured: 12 months
Systolic blood pressure
Systolic blood pressure assessed from electronic medical records
Measured: 24 months
Diastolic blood pressure
Diastolic blood pressure assessed from electronic medical records
Measured: 12 months
Diastolic blood pressure
Diastolic blood pressure assessed from electronic medical records
Measured: 24 months
HbA1c
HbA1c assessed from electronic medical records
Measured: 12 months
HbA1c
HbA1c assessed from electronic medical records
Measured: 24 months
Health-related quality of life
Assessed from the short form (SF-8) instrument; scale 0 - 100, higher is more favorable quality of life
Measured: 12 months
Health-related quality of life
Assessed from the short form-8 instrument; scale 0 - 100, higher is more favorable quality of life
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start31 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445168
- Sponsor's protocol ID
- KPSC IRB#10106M
- Acronym
- EPPC
- Status last verified
- Mar 2025
- First submitted
- 16 Jun 2020
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes
- ClinicalTrials.gov ID
- NCT04445168
- Acronym / sponsor ID
- EPPC / KPSC IRB#10106M
- Conditions
- PreDiabetes, Diabetes, Sedentary Behavior
- Keywords
- Physical activity, Randomized trial, Primary care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jun 2020 (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.
Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants assigned to usual care may receive advice from their primary care physician to increase their physical activity. They will receive handouts about every 6 weeks on general health topics. |
| Intervention | Experimental | Behavioral: Telephone-based motivational interviewsParticipants assigned to the intervention arm will receive telephone-based motivational interviews with trained interventionists to encourage increases in physical activity. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,
Key exclusion criteria (1 listed)
- Current use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,
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 |
|---|---|---|
| Telephone-based motivational interviews2-year telephone-based motivational interviews to increase physical activity. | Behavioural | Intervention |
Primary outcome
Moderate to vigorous physical activity (MVPA)
Time frame: 12 months
Accelerometer-derived 7-day MVPA
Moderate to vigorous physical activity (MVPA)
Time frame: 24 months
Accelerometer-derived 7-day MVPA
10 secondary outcomes
Weight
Time frame: 12 months
Weight
Time frame: 24 months
Systolic blood pressure
Time frame: 12 months
Systolic blood pressure
Time frame: 24 months
Diastolic blood pressure
Time frame: 12 months
Diastolic blood pressure
Time frame: 24 months
HbA1c
Time frame: 12 months
HbA1c
Time frame: 24 months
Health-related quality of life
Time frame: 12 months
Health-related quality of life
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-based motivational interviews in people with PreDiabetes and Diabetes, run by Kaiser Permanente at 1 site in United States.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Moderate to vigorous physical activity (MVPA) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2025.