Using Peer Support to Aid in Prevention and Treatment in Prediabetes

NCT03689530 | Completed Results

• 2 other identifiers: HUM001357451R18DK113403-01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PreDiabetes

Keywords

peer support

Outcome Measures

Primary Outcomes (2)

• Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months

  An A1C test measures the percentage of red blood cells that have glucose-coated hemoglobin. This percentage indicates average blood sugar levels over the last 2-3 months. Higher percentages indicate higher levels of blood sugar levels, and an A1c between 5.7% and 6.4% is considered in the prediabetes range. The negative numbers for change over time indicate an improvement because they show a drop in percentages from the baseline percentages.

  baseline to 6 months

• Change in Body Weight at 6 Months

  body weight in kilograms

  baseline to 6 months

Secondary Outcomes (22)

• Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Months

  baseline through 12 months

• Change in Body Weight at 12 Months

  baseline through 12 months

• Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetes

  baseline through 12 months

• Change in Number of Sessions Participant Attended in a Formal Program to Prevent Diabetes

  baseline through 12 months

• Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Week

  baseline through 12 months

Study Arms (2)

Peer Support Arm.

EXPERIMENTAL

Participants randomized to peer support will be matched with a peer supporter.

Behavioral: Peer Support

Enhanced Usual Care

ACTIVE COMPARATOR

Participants randomized to enhanced usual care will receive brief education and folder of information and resources.

Behavioral: Enhanced Usual Care

Interventions

Peer Support BEHAVIORAL

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.

Peer Support Arm.

Enhanced Usual Care BEHAVIORAL

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

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peer supporter:
• prior A1c 5.7 - 6.4 in last 3 years, with most recent being either lass than 5.7 or 0.4 points less than prior; AND/OR
• prior BMI \>=25 or \>=23 if Asian American in last three years with most recent 2% lower body weight;AND/OR
• prior completion of a wellness or diabetes prevention program; AND/OR
• completion of initial 6 months of UPSTART intervention as participant.
• Patient participant:
• no prior dx of DM or current use of anti-hyperglycemic medication;
• BMI \>=25 m2/kg or \>=23 if Asian; and
• A1c 5.7 - 6.4.

You may not qualify if:

• serious psychiatric disorder in past 24 months
• pregnant or planning pregnancy
• substance abuse in past 12 months
• diagnosis of dementia, bipolar, schizophrenia, personality disorder
• other serious concerns rendering possible development of diabetes unimportant to potential participant.

Sponsors & Collaborators

• University of Michigan: lead
• Kaiser Foundation Research Institute: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Kaiser Permanente Northern California

Oakland, California, 94611, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-2800, United States

Location

Related Publications (2)

• Heisler M, Dyer WT, Finertie H, Stoll SC, Wiley D, Turner CD, Sedgwick T, Kullgren J, Richardson CR, Hedderson M, Schmittdiel JA. Using Peer Support to Prevent Diabetes: Results of a Pragmatic RCT. Am J Prev Med. 2023 Aug;65(2):239-250. doi: 10.1016/j.amepre.2023.02.015. Epub 2023 Mar 8.

  PMID: 36898949 DERIVED

• Heisler M, Kullgren J, Richardson C, Stoll S, Alvarado Nieves C, Wiley D, Sedgwick T, Adams A, Hedderson M, Kim E, Rao M, Schmittdiel JA. Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART). Contemp Clin Trials. 2020 Aug;95:106048. doi: 10.1016/j.cct.2020.106048. Epub 2020 Jun 1.

  PMID: 32497783 DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Michele Heisler
• Organization: University of Michigan

mheisler@med.umich.edu

(734) 845-3504

Study Officials

• Mary Elllen M Heisler, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Julie A Schmittdiel, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 28, 2018
• Study Start: October 2, 2018
• Primary Completion: October 25, 2021
• Study Completion: April 15, 2022
• Last Updated: March 3, 2023
• Results First Posted: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)