Primary Care Community Partnerships to Prevent Diabetes

Not Applicable

Completed

• Conditions: Hyperglycemia; Diabetes Mellitus; Obesity
• Interventions: Behavioral: Dietitian Counseling Alone; Behavioral: Dietitian Plus Community Group Lifestyle

• Registration Number: NCT00656682
• Lead Sponsor: Northwestern University

Brief 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.

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-11
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-08
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietitian Counseling Alone	Dietitian Counseling Alone	Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone
Dietitian Plus Community Group Lifestyle	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.

Primary Outcome Measures

Name	Time	Method
% Change in Body Weight	12 months	(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)

Secondary Outcome Measures

Name	Time	Method
% Change in Blood Pressures	12 months	(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)
Changes in Physical Activity	12 months	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)
Changes in Dietary Composition	12 months	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)
Incremental Health State Utility	12 months
% Change in Blood Total Cholesterol	12 months	(total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline)
% Change in glycosylated hemoglobin	12 months	(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)
Incremental Costs	12 months
% Change in Body Weight	24 months	(weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States