Feasibility of a Partnered Approach to Prevent Diabetes
October 6, 2016 updated by: Ronald Ackermann, Northwestern University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46222
- IU Medical Group Westside Clinic
-
Indianapolis, Indiana, United States, 46227
- IU Medical Group Banta Road Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: one-on-one lifestyle
Clinical referral to diabetes prevention lifestyle intervention at School of Medicine campus
|
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
|
|
Experimental: group-based community lifestyle
Clinical referral to group diabetes prevention lifestyle intervention program in community
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Loss
Time Frame: 12 months
|
We analyzed repeated outcome measures using longitudinal linear regression with 3 observations per participant (baseline, 6 months, and 12 months)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self Report Physical Activity
Time Frame: 12 months
|
12 months
|
|
Rate of Community Program Participation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronald T Ackermann, MD, MPH, Northwestern University Feinberg School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
March 10, 2006
First Submitted That Met QC Criteria
March 10, 2006
First Posted (Estimate)
March 13, 2006
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
October 6, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK71527 (completed)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.