Feasibility of a Paternered Approach to Prevent Diabetes

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00302055
First received: March 10, 2006
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 YMCA 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 YMCA 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 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 YMCA 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 YMCA 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 YMCA sites, and a 3-year follow-up period.


Condition Intervention Phase
Pre-diabetic State
Overweight
Obesity
Behavioral: Clinical referral to research facility for traditional DPP lifestyle intervention
Behavioral: Clinical referral to YMCA site for group-based adaptation of DPP lifestyle intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Total costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self report physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of community program participation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: March 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
One-on-one intensive lifestyle program at School of Medicine campus
Behavioral: Clinical referral to research facility for traditional DPP lifestyle intervention
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: 2
Group-based lifestyle intervention program
Behavioral: Clinical referral to YMCA site for group-based adaptation of DPP lifestyle intervention
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: SBP >180 mmHg or DBP >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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302055

Locations
United States, Indiana
IU Medical Group Banta Road Clinic
Indianapolis, Indiana, United States
IU Medical Group Westside Clinic
Indianapolis, Indiana, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Ronald T Ackermann, MD, MPH Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Ronald T. Ackermann, MD, MPH, Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00302055     History of Changes
Other Study ID Numbers: DK71527 (completed)
Study First Received: March 10, 2006
Last Updated: January 14, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Prediabetic State
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014