Diabetes Mellitus, Hyperglycemia, Obesity
Conditions
Keywords
Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis
Brief summary
The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.
Detailed description
Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.
Interventions
BEHAVIORALDietitian Counseling Alone
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
BEHAVIORALDietitian Plus Community Group Lifestyle
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based lifestyle intervention offered by the Community to prevent diabetes
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Body-mass index of 24 kg/m2 or greater * Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
Exclusion criteria
* Cancer requiring treatment in the past 5 years * Uncontrolled hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg * Heart attack, stroke, or transient ischemic attack in the past 6 months, * Chronic obstructive airways disease or asthma requiring home oxygen * Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to \<5 years * Pregnancy * Existing diagnosis of diabetes mellitus * Fasting capillary blood glucose \> 125 mg/dl * 2-hour post-challenge capillary blood glucose \> 199 mg/dl * History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes * Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics) * Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Change in Body Weight | 12 months | (weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Change in glycosylated hemoglobin | 12 months | (HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline) |
| % Change in Blood Pressures | 12 months | (mean SBP at 12 months - mean SBP at baseline) / (mean SBP at baseline); (mean DBP at 12 months - mean DBP at baseline) / (mean DBP at baseline) |
| Changes in Dietary Composition | 12 months | NHIS Multifactor Screener: Change in % dietary kcal from fat at 12 months (est % dietary Kcal from fat at 12 months - est % dietary Kcal from fat at baseline) |
| % Change in Blood Total Cholesterol | 12 months | (total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline) |
| Incremental Costs | 12 months | — |
| Incremental Health State Utility | 12 months | — |
| % Change in Body Weight | 6 months | (weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline) |
| Changes in Physical Activity | 12 months | Paffenbarger PAQ: (Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at 12 months - Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at Baseline) |
Countries
United States
Outcome results
None listed