Fostering Sustainability Through Diabetes Self-Management Support

December 15, 2021 updated by: Gretchen Piatt, University of Michigan
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
358

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have Type 2 diabetes for at least 6 months
  • Be Black/African American
  • Be a resident of metro-Detroit, Toledo, or Flint
  • Be at least 21 years old
  • Be under the care of a physician for diabetes
  • Have transportation to attend the program

Exclusion Criteria:

  • Have Type 2 diabetes for less than 6 months
  • Under 21 years of age
  • Not under care of physician
  • Lack of transportation to attend the program

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parish Nurse plus Peer Leader
The focus of this approach is for Peer Leaders (PL) to provide Diabetes Self Management Support (DSMS) with the oversight of Parish Nurses (PN). The first component starts with group-based Diabetes Self Management Education (DSME) provided by Certified Diabetes Educators (CDE), co-facilitated by PN and PL and held at the church. PL will also facilitate activities including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit, with oversight of PN. As the study progresses, PL and PN will have progressive leadership responsibilities. Following DSME, participants will be invited to attend 12 months of monthly DSMS support groups led by the PL, with oversight from the PN. This approach allows for PN to provide direct supervision to PL in areas of clinical content, educational methods, and group facilitation and communication skills.
Behavioral: Diabetes Self Management Support (DSMS)
Experimental: Peer Leader Only
This approach will contain the same elements as the PN plus PL approach, except that a PN will not be used. Rather, PL will provide all aspects of DSMS, including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. This approach will be delivered in a group setting. DSME will be provided by CDEs and co-facilitated by a PL to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 monthly DSMS groups led by PL. Following the group sessions, participants will transition into a period of ongoing support. During this time, participants and PL will be encouraged to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. If needed, PL may contact the CDE for additional information
Behavioral: Diabetes Self Management Support (DSMS)
Experimental: Parish Nurse Only
The main focus of this approach will contain all of the same elements as the PN plus PL approach, except that PL will not be used. Rather, the PN will provide all aspects of Diabetes Self Management Support (DSMS), including facilitation of goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. Diabetes Self Management Education (DSME) will be provided by CDEs and co-facilitated by a PN to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 months of monthly, DSMS support groups led by the PN. Following support sessions, participants will transition into a period of ongoing support, where the participants and PN will be encouraged to continue to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. The PN may answer clinical questions and may contact the CDE for additional information if needed.
Behavioral: Diabetes Self Management Support (DSMS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in A1C Blood Glucose level
Time Frame: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.
An A1C test is a blood test that reflects one's average blood glucose levels over the previous 3 months.
During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gretchen Piatt, MPH, PhD, University of Michigan

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00104965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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