Primary Care Community Partnerships to Prevent Diabetes (RAPID)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RAckermann, Northwestern University
ClinicalTrials.gov Identifier:
NCT00656682
First received: April 10, 2008
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hyperglycemia
Obesity
Diabetes Mellitus
Behavioral: Dietitian Counseling Alone
Behavioral: Dietitian Plus Community Group Lifestyle

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Primary Care Community Partnerships to Prevent Diabetes

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • % Change in Body Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % Change in Blood Total Cholesterol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • % Change in glycosylated hemoglobin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • % Change in Blood Pressures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in Dietary Composition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in Physical Activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incremental Costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incremental Health State Utility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • % Change in Body Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • % Change in Body Weight [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 509
Study Start Date: April 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dietitian Counseling Alone
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone
Behavioral: Dietitian Counseling Alone
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
Experimental: 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.
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656682

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Ronald T Ackermann, MD, MPH Northwestern University School of Medicine
  More Information

No publications provided

Responsible Party: RAckermann, Associate Professor in Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT00656682     History of Changes
Other Study ID Numbers: R18 DK79855, R18DK079855
Study First Received: April 10, 2008
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
Prevention & Control
Hyperglycemia
Obesity
Diabetes Mellitus
Cost Benefit Analysis

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014