Primary Care Community Partnerships to Prevent Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Primary Care Community Partnerships to Prevent Diabetes

Conditions
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Hyperglycemia, Obesity, Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Dietitian Counseling Alone
* Behavioral: Dietitian Plus Community Group Lifestyle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietitian Counseling Alone<br>Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone | Behavioral: Dietitian Counseling Alone<br>* Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian<br>|
| Experimental: Dietitian Plus Community Group Lifestyle<br>Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention. | Behavioral: Dietitian Plus Community Group Lifestyle<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change in Body Weight | (weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change in Blood Total Cholesterol | (total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline) | 12 months | 
| % Change in glycosylated hemoglobin | (HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline) | 12 months | 
| % Change in Blood Pressures | (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) | 12 months | 
| Changes in Dietary Composition | 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) | 12 months | 
| Changes in Physical Activity | 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) | 12 months | 
| Incremental Costs |  | 12 months | 
| Incremental Health State Utility |  | 12 months | 
| % Change in Body Weight | (weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline) | 6 months | 
| % Change in Body Weight | (weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis