Primary Care Community Partnerships to Prevent Diabetes (RAPID)

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Obesity; Diabetes Mellitus
• Intervention / Treatment: Behavioral: Dietitian Counseling Alone; Behavioral: Dietitian Plus Community Group Lifestyle

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 Type: Interventional
• Enrollment (Actual): 509
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dietitian Counseling Alone; Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone	Behavioral: Dietitian Counseling Alone; Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
Experimental: 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% Change in Body Weight	(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% 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
% Change in glycosylated hemoglobin	(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)	12 months
% 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
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
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
Incremental Costs		12 months
Incremental Health State Utility		12 months
% Change in Body Weight	(weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline)	6 months
% Change in Body Weight	(weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)	24 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ronald T Ackermann, MD, MPH, Northwestern University School of Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: April 10, 2008
• First Submitted That Met QC Criteria: April 10, 2008
• First Posted (Estimate): April 11, 2008

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Diabetes Mellitus; Hyperglycemia; Prevention & Control; Cost Benefit Analysis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus
• Other Study ID Numbers: R18DK079855 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No