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

November 21, 2019 updated by: Emily Schroeder, Kaiser Permanente
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6588

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80014
        • Kaiser Permanente Coloado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4.5 months (6/26/2017-11/10/2017)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4.5 months (6/26/2017-11/10/2017)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Emily Schroeder, MD, PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Actual)

November 10, 2017

Study Completion (Actual)

November 10, 2017

Study Registration Dates

First Submitted

June 23, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-17-2437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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