CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 450 enrolled
Drug / intervention
Peer Support +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03689530
NCT03689530N/ACompleted

UPSTART: Using Peer Support to Aid in Prevention and Treatment in Prediabetes

University of Michigan·interventional·Posted Sep 28, 2018·Updated Mar 3, 2023

In Brief

A clinical study evaluating Peer Support and Enhanced Usual Care for PreDiabetes. Completed, enrolled 450 participants across 2 sites.

Detailed Summary

An estimated 86 million adults in the United States have prediabetes, and low-income Latino and African American adults have disproportionately high rates compared to non-Hispanic adults. Structured lifestyle interventions can prevent or delay type 2 diabetes in these at-risk populations and now are widely offered at community organizations and health systems. Yet, uptake of and engagement in available formal programs is very low. Low-income adults in particular face multiple barriers to navigating, engaging in, and sustaining involvement in available programs and lifestyle behaviors found to decrease progression to diabetes. It is critically important to develop and evaluate innovative approaches to increase uptake, engagement, and maintenance of gains in diabetes prevention activities. Peer support has been shown in the investigators' and others' effectiveness trials to be a sustainable, effective approach for positive behavior change and improved outcomes in adults with diabetes and other chronic conditions. The study team's pilot work suggests such approaches are feasible and acceptable among low-income Latino and African American patients with prediabetes to prevent chronic disease and better navigate their health care systems to obtain healthy lifestyle counseling and support. However, such peer support models among Latino, African American, and other low-income adults with prediabetes have not yet been rigorously evaluated. Accordingly, the study will conduct a parallel, two-arm randomized controlled trial in primary care centers in two different health systems that serve multi-ethnic communities with a high concentration of Latinos and African Americans and diverse socio-economic backgrounds. The study will compare enhanced usual care (providing referrals to diabetes prevention programs and resources) with a model of a structured behavioral change intervention supplementing enhanced referral to programs and resources with peer support to help link adults with prediabetes to existing health system and community diabetes prevention programs, to support their engagement in formal programs, maintain achieved gains, and support participants to initiate and sustain healthy behaviors to prevent diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreDiabetes
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 28, 2018
Enrollment StartOct 2, 2018
Primary CompletionOct 25, 2021
Study CompletionApr 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.8 years ago

Interventions

Peer Supportbehavioral

Participants will be paired with a peer supporter. They will meet in person one time and then be in contact by phone or texting on a weekly basis for the first 6 months of a year. During the final six months of the year, the peer supporter and participant will be in touch at least monthly. The peer supporter will help link participants to existing health system and community diabetes prevention programs, support their engagement in formal programs, maintain achieved gains, and support participants to initiate and sustain healthy behaviors to prevent diabetes. The 95 peer supporters who consented to participate in the study are included in this arm, along with the participants who were randomized to this arm, in the participant flow. The peer supporters were not randomized to the arm; rather, they consented to deliver the intervention. Although 95 consented, only 68 met with at least one peer, the first step in intervention delivery.

Enhanced Usual Carebehavioral

Participants will receive brief education and folder of information and resources.