NCT00302055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

December 18, 2014

Completed
Last Updated

December 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 10, 2006

Results QC Date

December 10, 2014

Last Update Submit

October 6, 2016

Conditions

Pre-diabetic StateOverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

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

    12 months

Secondary Outcomes (2)

  • Self Report Physical Activity

    12 months

  • Rate of Community Program Participation

    6 months

Study Arms (2)

one-on-one lifestyle

ACTIVE COMPARATOR

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

Behavioral: Clinical referral to diabetes prevention lifestyle

group-based community lifestyle

EXPERIMENTAL

Clinical referral to group diabetes prevention lifestyle intervention program in community

Behavioral: Clinical referral to group diabetes prevention lifestyle

Interventions

Clinical referral to diabetes prevention lifestyleBEHAVIORAL

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

one-on-one lifestyle
Clinical referral to group diabetes prevention lifestyleBEHAVIORAL

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

group-based community lifestyle

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • \- Use of a medications known to produce hyperglycemia
  • \- Known disease leading to abnormal glucose metabolism
  • \- Unable or unwilling to provide informed consent
  • Unable to communicate with the pertinent clinic staff
  • Unable to read written English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IU Medical Group Westside Clinic

Indianapolis, Indiana, 46222, United States

Location

IU Medical Group Banta Road Clinic

Indianapolis, Indiana, 46227, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Ronald T Ackermann
Organization
Northwestern University
r.ackermann@northwestern.edu
(312) 503-6400

Study Officials

  • Ronald T Ackermann, MD, MPH

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 13, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

December 1, 2016

Results First Posted

December 18, 2014

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)