Primary Care Community Partnerships to Prevent Diabetes

NCT ID: NCT00656682

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 509 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2013-08-31

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.

Conditions

Hyperglycemia; Obesity; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dietitian Counseling Alone

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone

Group Type: ACTIVE_COMPARATOR

Dietitian Counseling Alone

Intervention Type: BEHAVIORAL

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian

Dietitian 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 diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention.

Group Type: EXPERIMENTAL

Dietitian Plus Community Group Lifestyle

Intervention Type: BEHAVIORAL

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

Interventions

Dietitian Counseling Alone

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian

Intervention Type: BEHAVIORAL

Dietitian 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Ronald Ackermann

Senior Associate Dean for Public Health Director, Institute for Public Health and Medicine, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald T Ackermann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University School of Medicine

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R18DK079855

Identifier Type: NIH

Identifier Source: secondary_id

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R18DK079855

Identifier Type: NIH

Identifier Source: org_study_id

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