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Using Peer Support to Aid in Prevention and Treatment in Prediabetes (UPSTART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689530
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2018
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
Kaiser Foundation Research Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mary Ellen Michele Heisler, University of Michigan

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.

Condition or disease Intervention/treatment Phase
PreDiabetes Behavioral: Peer Support Behavioral: Enhanced Usual Care Not Applicable

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. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: UPSTART: Using Peer Support to Aid in Prevention and Treatment in Prediabetes
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Experimental: Peer Support Arm.
Participants randomized to peer support will be matched with a peer supporter.
Behavioral: 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.


Active Comparator: Enhanced Usual Care
Participants randomized to enhanced usual care will receive brief education and folder of information and resources.
Behavioral: Enhanced Usual Care
Participants will receive brief education and folder of information and resources.




Primary Outcome Measures :
  1. Change in Glycosylated Hemoglobin A1c (HbA1c) at 6 months [ Time Frame: baseline to 6 months ]
    HbA1c is a blood test that measures that average percent of glucose in blood

  2. Change in body weight at 6 months [ Time Frame: baseline to 6 months ]
    body weight in kilograms


Secondary Outcome Measures :
  1. Change in Glycosylated Hemoglobin A1c (HbA1c) at 12 months [ Time Frame: baseline through 12 months ]
    HbA1c is a blood test that measures that average percent of glucose in blood

  2. Change in body weight at 12 months [ Time Frame: baseline through 12 months ]
    body weight in kilograms

  3. Change in whether participant enrolled in a formal program to prevent diabetes [ Time Frame: baseline through 12 months ]
    one item with yes/no response

  4. Change in number of sessions participant attended in a formal program to prevent diabetes [ Time Frame: baseline through 12 months ]
    one item that asks participant to report number of sessions attended

  5. Change in frequency participant engages in moderate to vigorous physical activity [ Time Frame: baseline through 12 months ]
    one item that asks participant number of days in week, on average, participant engages in moderate to vigorous physical activity

  6. Change in duration participant engages in moderate to vigorous physical activity [ Time Frame: baseline through 12 months ]
    one item that asks participant number of minutes per week, on average, participant engages in moderate to vigorous physical activity

  7. Change in diet [ Time Frame: baseline through 12 months ]
    Participants will self-report diet using a 10 item custom survey developed by the study team

  8. Change in patient activation as measured by the Patient Activation Measure 13 (PAM-13) [ Time Frame: baseline through 12 months ]
    PAM-13 is a 13 item scale that measures participant beliefs, perceived knowledge, and confidence for engaging in behaviors related participant's health condition. It has a 0-100 scale, where a low score indicates low activation (disengaged and overwhelmed) and a high score indicates high activation (patient considers self their own advocate).

  9. Change in participant's perceived confidence in their ability to take steps to prevent diabetes using the Williams Perceived Competence Scale [ Time Frame: baseline through 12 months ]
    Williams Perceived Competence Scale comprises 4 items measuring the participant's perception of their own ability to take steps to prevent diabetes

  10. Change in participant's reasons for starting or continuing steps to prevent diabetes using the Treatment Self-Regulation Questionnaire (TSRQ) [ Time Frame: baseline through 12 months ]
    The Treatment Self-Regulation Questionnaire (TSRQ) consists of 11 items that measure participants' perceptions of how true various reasons to take steps to help prevent diabetes may be to the participants

  11. 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 [ Time Frame: baseline through 12 months ]
    12 items that ask the participant to indicate their level of agreement with statements regarding accessibility of others who could provide social support in attempts to prevent diabetes via healthy lifestyle changes. It includes items about others who also are at risk for developing diabetes.

  12. The role a participant's peer supporter played in assisting them to set and reach their goals using the Patient Assessment of Chronic Illness Care (PACIC) at 6 months [ Time Frame: 6 months ]
    The Patient Assessment of Chronic Illness Care (PACIC) consists of 5 items that ask the participant to state how often their peer supporter engaged in supportive behaviors regarding setting and achieving goals in order to make healthy lifestyle changes.

  13. The role a participant's peer supporter played in assisting them to set and reach their goals using the Patient Assessment of Chronic Illness Care (PACIC) at 12 months [ Time Frame: 12 months ]
    The Patient Assessment of Chronic Illness Care (PACIC) consists of 5 items that ask the participant to state how often their peer supporter engaged in supportive behaviors regarding setting and achieving goals in order to make healthy lifestyle changes.

  14. Participant's perceived autonomy support from their peer supporter using the Health Care Climate Questionnaire (HCCQ, long form) at 6 months [ Time Frame: 6 months ]
    The Health Care Climate Questionnaire (HCCQ, long form) consists of 15 items that ask the participant to rank their agreement with statements that indicate degree of autonomy support

  15. participant's perceived autonomy support from their peer supporter using the Health Care Climate Questionnaire (HCCQ, long form) at 12 months [ Time Frame: 12 months ]
    The Health Care Climate Questionnaire (HCCQ, long form) consists of 15 items that ask the participant to rank their agreement with statements that indicate degree of autonomy support



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689530


Locations
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United States, California
Kaiser Permanente Northern California
Oakland, California, United States, 94611
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-2800
Sponsors and Collaborators
University of Michigan
Kaiser Foundation Research Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Mary Elllen M Heisler, MD University of Michigan
Principal Investigator: Julie A Schmittdiel, PhD Kaiser Permanente
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary Ellen Michele Heisler, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03689530    
Other Study ID Numbers: HUM00135745
1R18DK113403-01 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Ellen Michele Heisler, University of Michigan:
peer support
Additional relevant MeSH terms:
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Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia