Feasibility of a Partnered Approach to Prevent Diabetes

Not Applicable

Completed

Conditions: Obesity
Pre-diabetic State
Overweight

Interventions: Behavioral: Clinical referral to group diabetes prevention lifestyle
Behavioral: Clinical referral to diabetes prevention lifestyle

Registration Number: NCT00302055

Lead Sponsor: Northwestern University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group-based community lifestyle	Clinical referral to group diabetes prevention lifestyle	Clinical referral to group diabetes prevention lifestyle intervention program in community
one-on-one lifestyle	Clinical referral to diabetes prevention lifestyle	Clinical referral to diabetes prevention lifestyle intervention at School of Medicine campus

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self Report Physical Activity	12 months
Rate of Community Program Participation	6 months

Trial Locations

Locations (2): IU Medical Group Banta Road Clinic
🇺🇸
Indianapolis, Indiana, United States
IU Medical Group Westside Clinic
🇺🇸
Indianapolis, Indiana, United States