Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare – The I-D-HEALTH Study

Overview

The purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.

Full Title of Study: “Community Translation of a Lifestyle Intervention to Improve Health in Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2016

Detailed Description

This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.

Interventions

  • Behavioral: Standard Lifestyle Advice
    • Standard clinical education is offered routinely by the participant’s usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
  • Behavioral: Advice Plus Lifestyle Intervention
    • Standard clinical education offered routinely by the participant’s usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.

Arms, Groups and Cohorts

  • Active Comparator: Standard Lifestyle Advice
    • Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant’s usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
  • Experimental: Advice Plus Lifestyle Intervention
    • Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant’s usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.

Clinical Trial Outcome Measures

Primary Measures

  • Percent Change in Body Weight
    • Time Frame: Baseline to 12 months
    • (Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.

Secondary Measures

  • Incremental Costs
    • Time Frame: 6, 12, and 24 months
    • The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.
  • Changes in Health State Utility
    • Time Frame: Baseline to 6,12, and 24 months
    • The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.
  • Percent Change in Body Weight
    • Time Frame: Baseline to 6 and 24 months
  • Percent Change in Blood Total Cholesterol
    • Time Frame: Baseline to 6, 12, and 24 months
  • Percent Change in A1c
    • Time Frame: Baseline to 6, 12, and 24 months
  • Percent Change in Blood Pressure
    • Time Frame: Baseline to 6, 12, and 24 months
  • Percent Change in Dietary Composition
    • Time Frame: Baseline to 6, 12, and 24 months
  • Percent Change in Physical Activity
    • Time Frame: Baseline to 6, 12, and 24 months

Participating in This Clinical Trial

Inclusion Criteria

1. 18 years of age or older, AND 2. Body-mass index of ≥ 24 kg/m2, AND 3. Documented Dysglycemia: Either by verification of laboratory test (Fasting Plasma Glucose 100-125 mg/dl OR 2-hour Post-challenge Plasma Glucose 140-199 mg/dl OR A1c 5.7%-10.9%) OR confirmation of Type 2 diabetes mellitus by self-report with verification Exclusion Criteria (any of the following): Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention: 1. Significant cardiovascular disease:

  • Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg – A1c > 10.9% – Heart attack, stroke, or transient ischemic attack (TIA) in the past 6 months – Chest pain, dizziness, or fainting with physical exertion 2. Lung disease: – Chronic obstructive airways disease or asthma requiring home oxygen 3. Pregnancy 4. Any other known condition that could limit ability to become physically active or limit life span to <5 years Exclusions related to metabolism: 1. Use of medications known to produce hyperglycemia 2. Known disease leading to abnormal glucose metabolism, other than diabetes mellitus, including Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis Exclusion for conditions or behaviors likely to affect the conduct of the study: 1. Unable or unwilling to provide informed consent 2. Unable to communicate with the pertinent research study staff 3. Unable to read written English or Spanish
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Northwestern University
    • Collaborator
      • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    • Provider of Information About this Clinical Study
      • Principal Investigator: Ronald Ackermann, Professor of Medicine – Northwestern University
    • Overall Official(s)
      • Ronald T. Ackermann, MD, MPH, Principal Investigator, Northwestern University (Illinois)

    Citations Reporting on Results

    Liss DT, Finch EA, Gregory DL, Cooper A, Ackermann RT. Design and participant characteristics for a randomized effectiveness trial of an intensive lifestyle intervention to reduce cardiovascular risk in adults with type 2 diabetes: The I-D-HEALTH study. Contemp Clin Trials. 2016 Jan;46:114-121. doi: 10.1016/j.cct.2015.11.016. Epub 2015 Dec 2.

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.