Clinical trial NCT00656682: Primary Care Community Partnerships to Prevent Diabetes
Official title: Primary Care Community Partnerships to Prevent Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Obesity
Diabetes Mellitus
Keywords: Prevention & Control
Hyperglycemia
Obesity
Diabetes Mellitus
Cost Benefit Analysis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-04-11
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: % Change in Body Weight
timeFrame: 12 months
Secondary outcomes:
measure: % Change in Blood Total Cholesterol
timeFrame: 12 months
measure: % Change in glycosylated hemoglobin
timeFrame: 12 months
measure: % Change in Blood Pressures
timeFrame: 12 months
measure: Changes in Dietary Composition
timeFrame: 12 months
measure: Changes in Physical Activity
timeFrame: 12 months
measure: Incremental Costs
timeFrame: 12 months
measure: Incremental Health State Utility
timeFrame: 12 months
measure: % Change in Body Weight
timeFrame: 6 months
measure: % Change in Body Weight
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University School of Medicine
name: Ronald T Ackermann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: