Using Peer Support to Aid in Prevention and Treatment in Prediabetes
Status: | Enrolling by invitation |
---|---|
Conditions: | Endocrine, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 10/24/2018 |
Start Date: | October 2, 2018 |
End Date: | June 30, 2022 |
UPSTART: Using Peer Support to Aid in Prevention and Treatment in Prediabetes
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.
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.
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.
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.
Inclusion Criteria:
Peer supporter:
- prior A1c 5.7 - 6.4
- current A1c improved
- prior BMI >=25 or >=23 if Asian American 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 as participant.
Patient participant:
- no prior dx of DM or 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
- dementia
- other serious concerns rendering possible development of diabetes unimportant to
potential participant.
We found this trial at
2
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials