| 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
|
| |
| |
| 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 |
|
|
| 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 |