Primary Care Community Partnerships to Prevent Diabetes

Obesity Clinical Trial

— RAPID  

Official title:

Primary Care Community Partnerships to Prevent Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656682
• Other study ID #: R18DK079855
• Secondary ID: R18DK079855
• Status: Completed
• Phase: N/A
• First received: April 10, 2008
• Last updated: March 27, 2018
• Start date: April 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hyperglycemia
• Obesity

Intervention

Behavioral:
• Dietitian Counseling Alone
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 lifestyle intervention offered by the Community to prevent diabetes

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Change in Body Weight	(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)	12 months
Secondary	% Change in Blood Total Cholesterol	(total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline)	12 months
Secondary	% Change in glycosylated hemoglobin	(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)	12 months
Secondary	% Change in Blood Pressures	(mean SBP at 12 months - mean SBP at baseline) / (mean SBP at baseline); (mean DBP at 12 months - mean DBP at baseline) / (mean DBP at baseline)	12 months
Secondary	Changes in Dietary Composition	NHIS Multifactor Screener: Change in % dietary kcal from fat at 12 months (est % dietary Kcal from fat at 12 months - est % dietary Kcal from fat at baseline)	12 months
Secondary	Changes in Physical Activity	Paffenbarger PAQ: (Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at 12 months - Total Kcal/week energy expenditure from walking, stairs, and leisure time activity at Baseline)	12 months
Secondary	Incremental Costs		12 months
Secondary	Incremental Health State Utility		12 months
Secondary	% Change in Body Weight	(weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline)	6 months
Secondary	% Change in Body Weight	(weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)	24 months