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Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200535
Recruitment Status : Completed
First Posted : June 27, 2017
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Emily Schroeder, Kaiser Permanente

Brief 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 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.

Condition or disease Intervention/treatment Phase
PreDiabetes Obesity Other: EHR gaps Other: Bulk outreach Other: Dietician call Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
Actual Study Start Date : June 26, 2017
Actual Primary Completion Date : November 10, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
No Intervention: Usual care
Usual care
Active Comparator: Electronic health record "gaps"
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
Other: EHR gaps
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient

Active Comparator: Bulk outreach
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
Other: EHR gaps
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient

Other: Bulk outreach
A bulk letter or email will be sent

Active Comparator: Personalized outreach
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
Other: EHR gaps
Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient

Other: Bulk outreach
A bulk letter or email will be sent

Other: Dietician call
Patients will receive a personalized call by a registered dietitian




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Enrollment in Diabetes Prevention or Weight Management Class (in Person) [ Time Frame: 4.5 months (6/26/2017-11/10/2017) ]
    Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kaiser Permanente Member
  • Age 18-75
  • Prediabetes
  • BMI >= 25
  • A1c 6.1-6.4%
  • No dietitian visit within the past 3 years

Exclusion Criteria:

- Pregnancy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200535


Locations
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United States, Colorado
Kaiser Permanente Coloado
Denver, Colorado, United States, 80014
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Emily Schroeder, MD, PhD Kaiser Permanente
  Study Documents (Full-Text)

Documents provided by Emily Schroeder, Kaiser Permanente:
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Responsible Party: Emily Schroeder, Investigator, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03200535    
Other Study ID Numbers: CO-17-2437
First Posted: June 27, 2017    Key Record Dates
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases