Diabetes Risk Education and Communication Trial
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/18/2018 |
| Start Date: | November 1, 2017 |
| End Date: | March 31, 2019 |
Diabetes Risk Education and Communication Trial (DiRECT)
A large body of research has demonstrated that intensive lifestyle interventions and
metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet
neither treatment is routinely used in practice. This pilot study will develop and evaluate
the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates
information about diabetes risk and treatment options for preventing diabetes among primary
care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project
has large potential to impact public health by developing a scalable intervention to promote
the use of evidence-based treatments that lower diabetes risk in this population.
metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet
neither treatment is routinely used in practice. This pilot study will develop and evaluate
the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates
information about diabetes risk and treatment options for preventing diabetes among primary
care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project
has large potential to impact public health by developing a scalable intervention to promote
the use of evidence-based treatments that lower diabetes risk in this population.
Landmark clinical trials have found that intensive lifestyle interventions (ILI) and
metformin are safe and effective treatment options for preventing diabetes among adults with
prediabetes and overweight/obesity. Despite being included in expert clinical guidelines,
these treatments are rarely used in practice and little existing research has focused on
approaches for promoting their use.
This novel intervention, delivered by medical assistants before patients' routinely scheduled
office visits, consists of the following 3 components intended to promote initiation of ILI
and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options
for preventing diabetes; 2) a "think aloud" exercise; and 3) formulating a preliminary
treatment plan. Previous studies report that medical assistants can improve uptake of some
preventive health services in primary care, which may also be true for ILI and metformin.
metformin are safe and effective treatment options for preventing diabetes among adults with
prediabetes and overweight/obesity. Despite being included in expert clinical guidelines,
these treatments are rarely used in practice and little existing research has focused on
approaches for promoting their use.
This novel intervention, delivered by medical assistants before patients' routinely scheduled
office visits, consists of the following 3 components intended to promote initiation of ILI
and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options
for preventing diabetes; 2) a "think aloud" exercise; and 3) formulating a preliminary
treatment plan. Previous studies report that medical assistants can improve uptake of some
preventive health services in primary care, which may also be true for ILI and metformin.
Inclusion Criteria:
- Overweight or obesity
- documentation of prediabetes in medical chart or
- A1c 5.7-6.4
Exclusion Criteria:
- Age < 18; individuals who are not yet adults (infants, children, teenagers)
- Patient's primary care physician did not provide permission to participate in the
study
- Pregnancy status: current or planned pregnancy during study period
- Serum creatinine >1.4mg/dL in women and >1.5mg/dL in men
- Patients that are blind, deaf, or otherwise unable to review study materials
- Prior diagnosis of diabetes mellitus type 1 or type 2 or on antidiabetic medication
- Diagnosis of post-surgical hypoinsulinemia
- Diagnosis of dementia
- Uncontrolled hypertension (≥160/100 mm Hg)
- No office visit in past 12 months
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