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Active, Not Recruiting

NCT Number: NCT06001801

The Inspiring Action to Prevent Diabetes Intervention

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

PreDiabetes Behavior Body Weight Body Weight Changes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Health and Social Services Center, Incorporated

Detroit, Michigan, 48209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Prevention Program

Behavioral

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.

INSPIRA

Behavioral

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 outcomes

  1. Number of group sessions attended by participants

    Time frame: 6 months

    This count will be out of 16 possible weekly group sessions.

Secondary outcomes

  1. Change in weight

    Time frame: baseline, 6 months

    Weight will be measured in pounds to the nearest tenth.

  2. Change in hemoglobin A1c

    Time frame: baseline, 6 months

  3. Change in waist circumference

    Time frame: baseline, 6 months

    This will be measured in centimeters.

  4. Change in reported diet quality

    Time frame: baseline, 6 months

    measured by comparing baseline and six month survey responses

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • American Diabetes Association

Registry information

Official study 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

Acronym: INSPIRA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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