Primary Care Community Partnerships to Prevent Diabetes - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00656682

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 YMCA is cost-effective for the prevention of type 2 diabetes.

Condition	Intervention	Phase
Hyperglycemia Obesity Diabetes Mellitus	Behavioral: Registered Dietitian Counseling Alone Behavioral: Registered Dietitian Counseling Plus YMCA Group Lifestyle Intervention	Phase II

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:

Primary Care Community Partnerships to Prevent Diabetes

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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 A1C [ 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 ]

Estimated Enrollment:

680

Study Start Date:

April 2008

Estimated Study Completion Date:

March 2011

Estimated Primary Completion Date:

March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian	Behavioral: Registered Dietitian Counseling Alone Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
2: Experimental Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based DPP lifestyle intervention offered by the YMCA	Behavioral: Registered Dietitian Counseling Plus YMCA Group Lifestyle Intervention 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 YMCA 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 YMCA 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 YMCA. 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: SBP >180 mmHg or DBP >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

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

Contacts

Contact: Emily Anderson, MA

317 278-0908

ea5@iupui.edu

Locations

United States, Indiana
IUMG Blackburn Clinic	Recruiting
Indianapolis, Indiana, United States, 46208
Contact: Kendra Murphy 317-554-4643 kedmurph@iupui.edu
IUMG Eagle Highlands Clinic	Recruiting
Indianapolis, Indiana, United States, 46254
Contact: Kendra Murphy 317-554-4643 kedmurph@iupui.edu
IUMG Epler Parke Clinic	Recruiting
Indianapolis, Indiana, United States, 46227
Contact: Kendra Murphy 317-554-4643 kedmurph@iupui.edu
IUMG Westside Clinic	Recruiting
Indianapolis, Indiana, United States, 46222
Contact: Kendra Murphy 317-554-4643 kedmurph@iupui.edu
IUMG Grassy Creek Clinic	Recruiting
Indianapolis, Indiana, United States, 46236
Contact: Jason Dority 317-278-0929 jdority@iupui.edu
IUMG Cottage Corner Clinic	Recruiting
Indianapolis, Indiana, United States, 46203
Contact: Jason Dority 317-278-0929 jdority@iupui.edu
IUMG Forest Manor Clinic	Recruiting
Indianapolis, Indiana, United States, 46226
Contact: Jason Dority 317-278-0929 jdority@iupui.edu
IUMG Castleton Clinic	Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Jason Dority 317-278-0929 jdority@iupui.edu

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Ronald T Ackermann, MD, MPH

Indiana University School of Medicine

More Information

Responsible Party:

Indiana University School of Medicine ( Ronald T. Ackermann, MD, MPH )

Study ID Numbers:

DK79855

First Received:

April 10, 2008

Last Updated:

October 7, 2008

ClinicalTrials.gov Identifier:

NCT00656682

Health Authority:

United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Prevention & Control
Hyperglycemia
Obesity
Diabetes Mellitus
Cost Benefit Analysis

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms

Hyperglycemia
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

ClinicalTrials.gov processed this record on January 07, 2009