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Primary Care Community Partnerships to Prevent Diabetes (RAPID)

Primary Purpose

Hyperglycemia, Obesity, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietitian Counseling Alone
Dietitian Plus Community Group Lifestyle
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dietitian Counseling Alone

Dietitian Plus Community Group Lifestyle

Arm Description

Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

% Change in Blood Total Cholesterol
(total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline)
% Change in glycosylated hemoglobin
(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)
% 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)
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)
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)
Incremental Costs
Incremental Health State Utility
% Change in Body Weight
(weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline)
% Change in Body Weight
(weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)

Full Information

First Posted
April 10, 2008
Last Updated
March 27, 2018
Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00656682
Brief Title
Primary Care Community Partnerships to Prevent Diabetes
Acronym
RAPID
Official Title
Primary Care Community Partnerships to Prevent Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Obesity, Diabetes Mellitus
Keywords
Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietitian Counseling Alone
Arm Type
Active Comparator
Arm Description
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone
Arm Title
Dietitian Plus Community Group Lifestyle
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietitian Counseling Alone
Intervention Description
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian
Intervention Type
Behavioral
Intervention Name(s)
Dietitian Plus Community Group Lifestyle
Intervention Description
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
Primary Outcome Measure Information:
Title
% Change in Body Weight
Description
(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
% Change in Blood Total Cholesterol
Description
(total blood cholesterol concentration at 12 months - total blood cholesterol concentration at baseline) / (total blood cholesterol concentration at baseline)
Time Frame
12 months
Title
% Change in glycosylated hemoglobin
Description
(HbA1c % at 12 months - HbA1c % at baseline) / (HbA1c % at baseline)
Time Frame
12 months
Title
% Change in Blood Pressures
Description
(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)
Time Frame
12 months
Title
Changes in Dietary Composition
Description
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)
Time Frame
12 months
Title
Changes in Physical Activity
Description
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)
Time Frame
12 months
Title
Incremental Costs
Time Frame
12 months
Title
Incremental Health State Utility
Time Frame
12 months
Title
% Change in Body Weight
Description
(weight in kg at 6 months - weight in kg at baseline) / (weight in kg at baseline)
Time Frame
6 months
Title
% Change in Body Weight
Description
(weight in kg at 24 months - weight in kg at baseline) / (weight in kg at baseline)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald T Ackermann, MD, MPH
Organizational Affiliation
Northwestern University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Primary Care Community Partnerships to Prevent Diabetes

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