Clinical trial NCT03689530: Using Peer Support to Aid in Prevention and Treatment in Prediabetes
Official title: UPSTART: Using Peer Support to Aid in Prevention and Treatment in Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: peer support
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-09-28
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 Months
timeFrame: baseline to 6 months
measure: Change in Body Weight at 6 Months
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 Months
timeFrame: baseline through 12 months
measure: Change in Body Weight at 12 Months
timeFrame: baseline through 12 months
measure: Change in Whether Participant Enrolled in a Formal Program to Prevent Diabetes
timeFrame: baseline through 12 months
measure: Change in Number of Sessions Participant Attended in a Formal Program to Prevent Diabetes
timeFrame: baseline through 12 months
measure: Change in Frequency and Duration Participant Engages in Moderate to Vigorous Physical Activity as Shown by Minutes Per Week
timeFrame: baseline through 12 months
measure: Change in the Number of Times Drinking Regular Soda or Pop That Contains Sugar
timeFrame: baseline through 12 months
measure: Change in Patient Activation as Measured by the Patient Activation Measure 13 (PAM-13)
timeFrame: baseline through 12 months
measure: Change in Participant's Perceived Confidence in Their Ability to Take Steps to Prevent Diabetes Using the Williams Perceived Competence Scale
timeFrame: baseline through 12 months
measure: Change in Autonomous Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Autonomous)
timeFrame: baseline through 12 months
measure: Change in the Participant's Level of Social Support Related to Improving Their Own Health Behaviors Using the Change in Health-Specific Social Support Scale
timeFrame: baseline through 12 months
measure: The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 6 Months
timeFrame: 6 months
measure: The Role a Participant's Peer Supporter Played in Assisting Them to Set and Reach Their Goals Using the Goal Setting and Intervention Tailoring Subscale of the Patient Assessment of Chronic Illness Care (PACIC) at 12 Months
timeFrame: 12 months
measure: Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 6 Months
timeFrame: 6 months
measure: Participant's Perceived Autonomy Support From Their Peer Supporter Using the Health Care Climate Questionnaire (HCCQ, Long Form) at 12 Months
timeFrame: 12 months
measure: Change in the Number of Times Drinking Sugary Drinks Besides Pop or Soda
timeFrame: baseline through 12 months
measure: Change in the Number of Times Eating Fruit
timeFrame: baseline through 12 months
measure: Change in the Number of Times Eating Vegetables
timeFrame: baseline through 12 months
measure: Change in the Number of Times Eating Meals Cooked With Olive Oil
timeFrame: baseline through 12 months
measure: Change in the Number of Times Eating Sweets or Desserts
timeFrame: baseline through 12 months
measure: Change in the Number of Times Eating Whole Grain Breads, Whole Grain Pasta, or Brown Rice
timeFrame: baseline through 12 months
measure: Change in the Number of Times Eating Breads, Pasta, Rolls, or Rice Made From White, Refined Grains
timeFrame: baseline through 12 months
measure: Change in Controlled Motivation to Prevent Diabetes Using the Treatment Self-Regulation Questionnaire (TSRQ - Controlled)
timeFrame: baseline through 12 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mary Elllen M Heisler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Julie A Schmittdiel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.