Jump Start Shared Medical Appointments for Diabetes With Weight Management
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The proposed research will test a novel program that combines intensive weight management
      with shared (group) medical appointments for patients with diabetes. This research is
      important because diabetes is increasingly prevalent, it requires complex management by the
      provider and the patient, and weight loss is a critical component of its management. Adding
      weight management to shared medical appointments could potentially improve blood sugar
      control while reducing medications and their side effects such as low blood sugar.
    

Detailed description: 
      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.
    

Intervention name(s): Weight management; Shared medical appointments (SMA)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weight management group visits using low-carbohydrate diet followed for weight management.; Diabetes management group visits for diabetes management.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes; Obesity; Complex Care; Primary Care; Chronic Disease