Full Text View
Tabular View
No Study Results Posted
Related Studies
Primary Care Community Partnerships to Prevent Diabetes (RAPID)
This study is currently recruiting participants.
Study NCT00656682   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: April 10, 2008   Last Updated: October 5, 2009   History of Changes

April 10, 2008
October 5, 2009
April 2008
March 2010   (final data collection date for primary outcome measure)
% Change in Body Weight [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00656682 on ClinicalTrials.gov Archive Site
  • % 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 ]
Same as current
 
Primary Care Community Partnerships to Prevent Diabetes
Primary Care Community Partnerships to Prevent Diabetes

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.

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.

Phase II
Interventional
Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Hyperglycemia
  • Obesity
  • Diabetes Mellitus
  • Behavioral: Registered Dietitian Counseling Alone
  • Behavioral: Registered Dietitian Counseling Plus YMCA Group Lifestyle Intervention
  • Active Comparator: Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
  • 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
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
680
March 2011
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Emily Anderson, MA 317 278-0908 ea5@iupui.edu
United States
 
NCT00656682
Ronald T. Ackermann, MD, MPH, Indiana University School of Medicine
DK79855
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
Principal Investigator: Ronald T Ackermann, MD, MPH Indiana University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP