PreDiabetesNCT03200535
Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
A study testing EHR gaps, Bulk outreach and Dietician call in people with PreDiabetes and Obesity, run by Kaiser Permanente at 1 site in United States.
Trial summary
Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PreDiabetes, Obesity
- What is being tested?
- EHR gaps, Bulk outreach and Dietician call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,588 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 10 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kaiser Permanente Member
- Age 18-75
- Prediabetes
- BMI >= 25
- A1c 6.1-6.4%
- No dietitian visit within the past 3 years
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser Permanente Colorado members in these activities is low. The purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities.
- Conditions
- PreDiabetes, Obesity
- Being tested
- EHR gaps, Bulk outreach, Dietician call
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR gapsOther
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
Bulk outreachOther
A bulk letter or email will be sent
Dietician callOther
Patients will receive a personalized call by a registered dietitian
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care |
| Electronic health record "gaps" | Active comparator | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Receives: Other: EHR gaps |
| Bulk outreach | Active comparator | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent Receives: Other: EHR gaps; Other: Bulk outreach |
| Personalized outreach | Active comparator | Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian Receives: Other: EHR gaps; Other: Bulk outreach; Other: Dietician call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in Diabetes Prevention or Weight Management Class (Online)
Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period
Measured: 4.5 months (6/26/2017-11/10/2017)
Secondary outcomes (1)
Enrollment in Diabetes Prevention or Weight Management Class (in Person)
Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period
Measured: 4.5 months (6/26/2017-11/10/2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start26 Jun 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index \>=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.
- Masking
- None (open label)
- Enrolment
- 6,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Schroeder, Kaiser Permanente
- Investigators
- Emily Schroeder, MD, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200535
- Sponsor's protocol ID
- CO-17-2437
- Status last verified
- Nov 2019
- First submitted
- 23 Jun 2017
- Last updated
- 13 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
- ClinicalTrials.gov ID
- NCT03200535
- Acronym / sponsor ID
- CO-17-2437
- Conditions
- PreDiabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,588 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser Permanente Colorado members in these activities is low. The purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index >=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care |
| Electronic health record "gaps" | Active comparator | Other: EHR gapsGaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient |
| Bulk outreach | Active comparator | Other: EHR gaps, Other: Bulk outreachGaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent |
| Personalized outreach | Active comparator | Other: EHR gaps, Other: Bulk outreach, Other: Dietician callGaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Kaiser Permanente Member
- Age 18-75
- Prediabetes
- BMI >= 25
- A1c 6.1-6.4%
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| EHR gapsGaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient | Other | Bulk outreach, Electronic health record "gaps", Personalized outreach |
| Bulk outreachA bulk letter or email will be sent | Other | Bulk outreach, Personalized outreach |
| Dietician callPatients will receive a personalized call by a registered dietitian | Other | Personalized outreach |
Primary outcome
Enrollment in Diabetes Prevention or Weight Management Class (Online)
Time frame: 4.5 months (6/26/2017-11/10/2017)
Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period
1 secondary outcome
Enrollment in Diabetes Prevention or Weight Management Class (in Person)
Time frame: 4.5 months (6/26/2017-11/10/2017)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Emily Schroeder, MD, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EHR gaps, Bulk outreach and Dietician call in people with PreDiabetes and Obesity, 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 6 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: finished, as of the sponsor's last update on 13 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Enrollment in Diabetes Prevention or Weight Management Class (Online) (time frame: 4.5 months (6/26/2017-11/10/2017)). 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 13 Dec 2019.