Using Peer Support to Aid in Prevention and Treatment in Prediabetes

NCT ID: NCT03689530

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2022-04-15

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.

Detailed Description

The intervention seeks to address the need to test in routine primary care evidence-based approaches to increase uptake, engagement, and maintenance of healthy behaviors necessary to decrease progression to diabetes among primary care patients with prediabetes, especially low-income and racial and ethnic minority adults with prediabetes. The study will conduct a parallel, two-armed, randomized controlled pragmatic clinical trial including adults with prediabetes at two primary care centers in two different health systems: Kaiser Permanente Northern California and the University of Michigan Health System. Each health system received IRB approval from its own IRB to accommodate site-specific nuances in its implementation. The trial will evaluate whether adding a 12-month predominantly telephone-based volunteer peer support program (UPSTART) to health care provider counseling and referral to diabetes prevention programs leads to greater improvements in A1c, the weight loss, and waist circumference than health care provider counseling and referral alone (Aim 1). The study will also compare differences in reported physical activity, diet, and enrollment and engagement in diabetes prevention programs as potential mediators as well as autonomous motivation, behavior-specific self-efficacy, patient activation, and perceived support; and moderators such as health literacy (Aim 2). To enhance adoption of the intervention by the two study health systems and dissemination to other health systems if effective, the study will evaluate costs and use an integrated RE-AIM and Consolidated Framework for Implementation Research (CFIR) framework to evaluate processes of intervention implementation in the two primary care settings (Aim 3). The study duration will be 5 years, to allow for peer supporter and patient recruitment, completion of the 12-month program, and assessment of outcomes at 6 months and at 12 months.

The study will use mixed methods-i.e., the collection, analysis, and combining of both quantitative and qualitative data-to investigate elements important for implementation and dissemination. The study will gather data on how peer supporters, primary care clinic staff, and patients experience the intervention and how the experiences of participants together with the trial's results suggest the study should modify the intervention. Using this approach, the study aim to ensure that the intervention has the greatest possible likelihood of adoption in both UMHS and KPNC health systems should the study find it has positive effects on processes and outcomes of care. The UPSTART intervention is designed for peers to interact and provide support in a way that is autonomy supportive with the goal of enhancing autonomous motivation and self-efficacy for healthy behaviors. The study will hold periodic initial trainings for new peer supporters over the study period. In addition, peer supporters will receive: 1) routine, structured check-ins that will include monthly peer support group meetings (with option to call in) to allow exchange; 2) back-up support: offering peer supporters contact information for staff who they can call; and 3) continuing education and booster training at the monthly group meetings to enrich their skill sets and knowledge.

The peer supporters were included in the total number of participant numbers for the trial and in the intervention arm in the study flow portion of this record because they were consented. Demographic characteristics of the peer supporters are also reported. However, they were not randomized; they were recruited to deliver the intervention to recruited participants with prediabetes whose outcomes we aimed to improve through the delivered intervention. The peer supporters' involvement was to deliver the intervention to the participants who were randomized to either receive the peer support intervention or to enhanced usual care. The study consented the peer supporters because they completed surveys at three time points; the intent was to look at whether delivering the intervention affected the peer supporters' own reported behaviors as exploratory only. There was and is no intention to compare coach data to primary, secondary, or any other outcome measures of the randomized participants in the trial.

During the trial, another primary care center within the University of Michigan Health System was added. Because this center was within the University of Michigan Health System, and all contact information was identical, there was no reason to add another participating site.

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Peer Support Arm.

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

Group Type: EXPERIMENTAL

Peer Support

Intervention Type: 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.

Enhanced Usual Care

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

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

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

Interventions

Peer Support

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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kaiser Foundation Research Institute

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Mary Ellen Michele Heisler

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary Elllen M Heisler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Julie A Schmittdiel, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Northern California

Oakland, California, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36898949 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32497783 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R18DK113403-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00135745

Identifier Type: -

Identifier Source: org_study_id