Clinical trial NCT00302055: Feasibility of a Partnered Approach to Prevent Diabetes
Official title: Feasibility of a Partnered Approach to Prevent Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetic State
Overweight
Obesity
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2006-03-13
Enrollment: 72
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

25 years of age or older Body-mass index of \>= 24 kg/m2

1. 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

Primary outcomes:
measure: Weight Loss
timeFrame: 12 months
Secondary outcomes:
measure: Self Report Physical Activity
timeFrame: 12 months
measure: Rate of Community Program Participation
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Medical Group Westside Clinic
state: Indiana
city: Indianapolis
country: United States
facility: IU Medical Group Banta Road Clinic
state: Indiana
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Ronald T Ackermann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: