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The Inspiring Action to Prevent Diabetes Intervention (INSPIRA)

Primary Purpose

PreDiabetes

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Prevention Program
INSPIRA
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Diabetes Prevention Program, Behaviors, Weight loss, Healthy lifestyle changes, Peer Partner

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English or Spanish-speaking Body Mass Index (BMI) > 24.9 kilograms/meters squared (kg/m2) The most recent A1c test, completed in 60 days or fewer prior to enrollment, is 5.7%-6.4% Exclusion Criteria: Diagnosed with schizophrenia Active alcohol or other drug abuse Are pregnant or planning pregnancy in next 6 months Will not be in local area in six months Will not be able to attend sessions, in-person or remotely, for three more weeks

Sites / Locations

  • Community Health and Social Services Center, Incorporated

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diabetes Prevention Program (DPP) (usual care)

DPP plus the INSPIRA intervention

Arm Description

This arm will include the DPP plus additional interventions.

Outcomes

Primary Outcome Measures

Change in weight
Weight will be measured in pounds.

Secondary Outcome Measures

Change in hemoglobin A1c
Change in waist circumference
This will be measured in centimeters.
Number of group sessions attended by participants
Change in reported diet quality
measured by comparing baseline and six month survey responses

Full Information

First Posted
August 14, 2023
Last Updated
October 3, 2023
Sponsor
University of Michigan
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT06001801
Brief Title
The Inspiring Action to Prevent Diabetes Intervention
Acronym
INSPIRA
Official Title
Leveraging Peer Support and Vouchers for Healthy Food to Increase Engagement in Diabetes Prevention Behaviors Among Low-income Adults With Prediabetes: the INSPIRing Action to Prevent Diabetes (INSPIRA) Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This research is studying how to help increase uptake of and engagement in formal Diabetes Prevention Programs to improve healthy behaviors among adults with pre diabetes to reduce risk of getting diabetes. This project will compare the Diabetes Prevention Program (DPP) to participating in the DPP program plus two extra pieces (INSPIRA). The 2 additional pieces in the DPP plus program includes getting matched with someone else in the program to provide each other support along with a chance to earn healthy food vouchers. Eligible participants will be randomized to one of the two groups and be asked to participate for approximately 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Diabetes Prevention Program, Behaviors, Weight loss, Healthy lifestyle changes, Peer Partner

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Prevention Program (DPP) (usual care)
Arm Type
Active Comparator
Arm Title
DPP plus the INSPIRA intervention
Arm Type
Experimental
Arm Description
This arm will include the DPP plus additional interventions.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program
Intervention Description
The DPP group is led by the Community Health and Social Services Center (CHASS) community health workers (CHWs). For this study, the workers will deliver 16 weekly sessions (core phase) followed by two monthly sessions (maintenance phase). Each session lasts one hour plus the time required to weigh each participant and review food and activity logs. This program will help participants make healthy lifestyle changes. Examples are improvements in eating and physical activity. The goal is that participants lose some weight and eat healthier food. Sessions will be offered in-person in a room with video capacity to allow attendance of participants that cannot attend in person. For those participating virtually, the CHWs will briefly review with them what participants logged. Participation in this project should last approximately 6-months.
Intervention Type
Behavioral
Intervention Name(s)
INSPIRA
Intervention Description
This intervention will include the DPP plus additional interventions. The additional interventions include: participants to stay for an extra 30 minutes following the regular DPP sessions. In these INSPIRA sessions, participants will be trained in providing mutual peer support, be matched with a peer partner and asked to talk at least once a week, receive vouchers or gift cards, discuss participants action plans with the peer partner, and share challenges, successes, and tips from the CHW and others in the session. CHWs will provide brief trainings on autonomy-supportive peer support approaches over the first three weeks of sessions. Participation in this project should last approximately 6-months.
Primary Outcome Measure Information:
Title
Change in weight
Description
Weight will be measured in pounds.
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in hemoglobin A1c
Time Frame
baseline, 6 months
Title
Change in waist circumference
Description
This will be measured in centimeters.
Time Frame
baseline, 6 months
Title
Number of group sessions attended by participants
Time Frame
6 months
Title
Change in reported diet quality
Description
measured by comparing baseline and six month survey responses
Time Frame
baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English or Spanish-speaking Body Mass Index (BMI) > 24.9 kilograms/meters squared (kg/m2) The most recent A1c test, completed in 60 days or fewer prior to enrollment, is 5.7%-6.4% Exclusion Criteria: Diagnosed with schizophrenia Active alcohol or other drug abuse Are pregnant or planning pregnancy in next 6 months Will not be in local area in six months Will not be able to attend sessions, in-person or remotely, for three more weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Ellen M Heisler, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health and Social Services Center, Incorporated
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Inspiring Action to Prevent Diabetes Intervention

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