Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
296

Summary

Conditions
Prediabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

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 e...

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. 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.

Tracking Information

NCT #
NCT03689530
Collaborators
  • Kaiser Foundation Research Institute
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Mary Elllen M Heisler, MD University of Michigan Principal Investigator: Julie A Schmittdiel, PhD Kaiser Permanente