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Feasibility of a Partnered Approach to Prevent Diabetes

Primary Purpose

Pre-diabetic State, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical referral to diabetes prevention lifestyle
Clinical referral to group diabetes prevention lifestyle
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetic State

Eligibility Criteria

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

Inclusion Criteria: 25 years of age or older Body-mass index of >= 24 kg/m2 or more additional risk factors if age is <45 - Parent or sibling with diabetes Minority race or ethnicity History of gestational diabetes Delivery of infant >= 9 lbs. History of high blood pressure History of dyslipidemia Polycystic Ovarian Syndrome History of vascular disease Fasting Capillary Glucose 95 - 125 mg/dl 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl Exclusion Criteria: Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years - Significant Cardiovascular Disease - A "Yes" response to any item on the modified Physical Activity Readiness Questionnaire - Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg Heart attack, stroke, or transient ischemic attack within 6 months Chest pain or unexplained dizziness or fainting with physical exertion Chronic obstructive pulmonary disease or asthma needing 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 Any other known reason for not participating in regular physical activity Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes - Use of a medications known to produce hyperglycemia - Known disease leading to abnormal glucose metabolism Exclusions for conditions / behaviors likely to affect study conduct - Unable or unwilling to provide informed consent Unable to communicate with the pertinent clinic staff Unable to read written English or Spanish

Sites / Locations

  • IU Medical Group Westside Clinic
  • IU Medical Group Banta Road Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

one-on-one lifestyle

group-based community lifestyle

Arm Description

Clinical referral to diabetes prevention lifestyle intervention at School of Medicine campus

Clinical referral to group diabetes prevention lifestyle intervention program in community

Outcomes

Primary Outcome Measures

Weight Loss
We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)

Secondary Outcome Measures

Self Report Physical Activity
Rate of Community Program Participation

Full Information

First Posted
March 10, 2006
Last Updated
October 6, 2016
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00302055
Brief Title
Feasibility of a Partnered Approach to Prevent Diabetes
Official Title
Feasibility of a Partnered Approach to Prevent Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention resulting in modest weight loss and increased physical activity can delay or prevent the development of type 2 diabetes in those at increase risk for the disease. The lifestyle program used, however, was not designed for delivery on a public health scale. Successful DPP translation will require a sustainable partnership between a health care system and an established community organization committed to community health and experienced in implementing sustainable health and wellness programs. We have been collaborating with local health system and community administrators for over a year to design a 'real-world' clinic-based screening model to identify and refer high-risk patients for a group-based adaptation of the DPP lifestyle intervention in community facilities. We have designed this study to develop preliminary data about the feasibility and yield of clinic-based screening and referral, as well as the effectiveness of the adapted lifestyle intervention. This pilot study seeks to: 1) evaluate the feasibility of a strategy to implement American Diabetes Association (ADA) recommendations for clinic-based diabetes-risk testing and to refer high-risk patients for a community-based lifestyle intervention; 2) compare two strategies to enhance community-based program participation by referred patients; 3) demonstrate the capability of community facilities to schedule and enroll referred clinic patients at high-risk for diabetes and to deliver a modified, group-based DPP lifestyle intervention consistently; and 4) compare levels of weight loss and physical activity achieved by referred clinic patients with pre-diabetes who participate in a free-of-charge, group-based DPP lifestyle intervention at community facilities compared to a free-of-charge, traditional, one-on-one DPP lifestyle intervention at a DPP research site. Addressing these issues now will enable us to evaluate this partnered DPP translation model with a larger, more robust future study that will involve referral by multiple primary care clinics, program delivery at more community sites, and a 3-year follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetic State, Overweight, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one-on-one lifestyle
Arm Type
Active Comparator
Arm Description
Clinical referral to diabetes prevention lifestyle intervention at School of Medicine campus
Arm Title
group-based community lifestyle
Arm Type
Experimental
Arm Description
Clinical referral to group diabetes prevention lifestyle intervention program in community
Intervention Type
Behavioral
Intervention Name(s)
Clinical referral to diabetes prevention lifestyle
Intervention Description
16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
Intervention Type
Behavioral
Intervention Name(s)
Clinical referral to group diabetes prevention lifestyle
Intervention Description
16 one-hour lifestyle program sessions (diet and physical activity skill building and problem solving) delivered about once weekly over 20-24 weeks, followed by monthly lifestyle maintenance sessions
Primary Outcome Measure Information:
Title
Weight Loss
Description
We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Self Report Physical Activity
Time Frame
12 months
Title
Rate of Community Program Participation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 25 years of age or older Body-mass index of >= 24 kg/m2 or more additional risk factors if age is <45 - Parent or sibling with diabetes Minority race or ethnicity History of gestational diabetes Delivery of infant >= 9 lbs. History of high blood pressure History of dyslipidemia Polycystic Ovarian Syndrome History of vascular disease Fasting Capillary Glucose 95 - 125 mg/dl 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl Exclusion Criteria: Diseases that could limit lifespan or increase risk with a lifestyle intervention - Cancer diagnosed in the past 5 years - Significant Cardiovascular Disease - A "Yes" response to any item on the modified Physical Activity Readiness Questionnaire - Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg Heart attack, stroke, or transient ischemic attack within 6 months Chest pain or unexplained dizziness or fainting with physical exertion Chronic obstructive pulmonary disease or asthma needing 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 Any other known reason for not participating in regular physical activity Exclusions related to metabolism - Past anti-diabetes medication use, except during gestational diabetes - Use of a medications known to produce hyperglycemia - Known disease leading to abnormal glucose metabolism Exclusions for conditions / behaviors likely to affect study conduct - Unable or unwilling to provide informed consent Unable to communicate with the pertinent clinic staff Unable to read written English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald T Ackermann, MD, MPH
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Medical Group Westside Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
Facility Name
IU Medical Group Banta Road Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of a Partnered Approach to Prevent Diabetes

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