Jump Start Shared Medical Appointments for Diabetes With Weight Management

Anticipated Impacts on Veteran's Healthcare: Weight management is an important focus of VA as
evidenced by its VA/DoD Clinical Practice Guideline and MOVE! program targeting
overweight/obesity. VA is also committed to using group visits to increase the efficiency and
effectiveness of health care delivery. The investigators aim to test a novel intervention
that combines intensive weight and diabetes management using the SMA platform. This research
addresses important missions to VA because diabetes is more prevalent in Veterans than in the
general population, and because weight management is more challenging and complex in patients
with diabetes. Project Background: SMAs involve groups of patients who share a common chronic
condition and meet over time to receive education, self-management enhancement, and
medication management to improve clinical outcomes. A systematic review by VA found that SMAs
modestly improve glycemia in patients with diabetes. Although these SMA programs sometimes
included diet and physical activity counseling, weight management was not a primary goal, and
weight typically was not reduced. Instead, medication intensification was the primary
strategy for improving glycemia, and this strategy can lead to weight gain.

For overweight patients with diabetes, weight loss is first-line therapy because it can
improve glycemic control and because excess weight leads to poorer outcomes. Moreover, many
antiglycemic medications cause weight gain and hypoglycemic events, which may counteract the
potential macrovascular benefits of glycemic control. Dietary interventions, however, can
lower weight and improve glycemic control while reducing antiglycemic medication needs and,
therefore, subsequent risk for hypoglycemic episodes.

In prior research, the investigators induced weight loss and improved glycemic control while
decreasing antiglycemic medications. A combination of an intensive weight management program
with the diabetes management offered in SMAs has potential to further improve diabetes
outcomes, reduce complications, decrease costs and increase health-related quality of life.
Such a combined intervention is ideal for patients with diabetes because of their unique
dietary considerations, and their need for careful glycemic and medication management during
weight loss. Project Objectives: The investigators will examine whether an intensive,
group-based weight management program followed by an SMA intervention (WM/SMA arm) is
comparably effective (non-inferior) to the SMA intervention alone for improving glycemic
control while using less antiglycemic medication and resulting in fewer hypoglycemic events
and lower healthcare costs. Project Methods: 308 overweight VA outpatients with uncontrolled
(hemoglobin A1c 8.0% or 7.5% or greater for those under 50) type 2 diabetes will participate
in this RCT. Similar to prior SMAs, the SMA visits will occur every 4 weeks for 16 weeks and
then every 8 weeks for 32 weeks for a total of 9 visits. Sessions will be led by a physician
and trained interventionists, and will include educational topics related to diabetes
management (including diet and physical activity), self-management training, and medication
adjustment. Similar to the investigators' prior weight management trials, the WM/SMA group
will meet every 2 weeks for 16 weeks and then every 8 weeks for 32 weeks for a total of 13
visits. The weight management program will focus on a low carbohydrate dietary pattern
because of its potential to lower glycemia, leading to reduced antiglycemic medication needs.
After 16 weeks, meeting content will shift to the SMA intervention content but weight
management will continue to be addressed at the meetings. The primary outcome is glycemic
control assessed by hemoglobin A1c assessed at baseline and at 16, 32, and 48 weeks.
Secondary outcomes include hypoglycemic events, changes in the antiglycemic medication
regimen as assessed by a summary score, weight and healthcare costs. Diabetes-specific
health-related quality of life and medication adherence will also be assessed.

Inclusion Criteria:

- Diagnosis of type 2 diabetes,

- Hemoglobin A1c >= 8.0% or , >= for those less than 50

- BMI >= 27 kg/m2,

- Interest in losing weight,

- Agrees to attend regular visits per study protocol,

- Has access to reliable transportation,

- Has a VAMC provider.

Exclusion Criteria:

- Age >= 75 years old,

- Hemoglobinopathy that interferes with measurement of hemoglobin A1c,

- Certain chronic or unstable diseases that may put the participant at increased risk.
These include the following:

- Kidney disease (serum creatinine >1.5 mg/dL in men, >1.3 mg/dL in women),

- Type 1 diabetes,

- Unstable CHD (unstable angina, current/active coronary ischemia workup),

- Blood pressure 160/100 mm Hg,

- Fasting triglycerides 600 mg/dL,

- Fasting serum LDL-C 190 mg/dL,

- Pregnancy, breastfeeding, or lack of birth control if premenopausal,

- Dementia, psychiatric illness, or substance abuse that may interfere with adherence
(e.g. illness that is currently unstable or resistant to first-line therapy; substance
abuse in the past year),

- Enrollment in another research study that might affect the main outcomes of this
study.