Using Peer Support to Aid in Prevention and Treatment in Prediabetes
Condition: PreDiabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

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.
    

Intervention name(s): Peer Support; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Participants will receive brief education and folder of information and resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: peer support