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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01435603
Recruitment Status : Completed
First Posted : September 16, 2011
Results First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ronald Ackermann, Northwestern University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hyperglycemia Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Behavioral: Standard Lifestyle Advice Behavioral: Advice Plus Lifestyle Intervention Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Community Translation of a Lifestyle Intervention to Improve Health in Diabetes
Study Start Date : August 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016
Arms and Interventions
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Arm Intervention/treatment
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).
 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.
Other Name: Brief Lifestyle Advice
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.
 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.
Other Name: Brief Lifestyle Advice

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.
Other Names:
  • Plan Ahead Lifestyle Intervention
  • Intensive Lifestyle Intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Percent Change in Body Weight [ Time Frame: Baseline to 6 and 24 months ]
  4. Percent Change in Blood Total Cholesterol [ Time Frame: Baseline to 6, 12, and 24 months ]
  5. Percent Change in A1c [ Time Frame: Baseline to 6, 12, and 24 months ]
  6. Percent Change in Blood Pressure [ Time Frame: Baseline to 6, 12, and 24 months ]
  7. Percent Change in Dietary Composition [ Time Frame: Baseline to 6, 12, and 24 months ]
  8. Percent Change in Physical Activity [ Time Frame: Baseline to 6, 12, and 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435603


Locations
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United States, Illinois
YMCA of Metro Chicago
Chicago, Illinois, United States, 60610
McGaw YMCA
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Northwestern University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ronald T. Ackermann, MD, MPH Northwestern University (Illinois)
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ronald Ackermann, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01435603    
Other Study ID Numbers: STU00056501
R18DK083941 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2011    Key Record Dates
Results First Posted: April 27, 2018
Last Update Posted: April 27, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ronald Ackermann, Northwestern University:
Prevention & Control
Hyperglycemia
Obesity
Diabetes Mellitus
Cost Benefit Analysis
Additional relevant MeSH terms:
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Diabetes Mellitus
Hyperglycemia
Metabolic Diseases
Glucose Metabolism Disorders
Nutrition Disorders
Overnutrition
 Endocrine System Diseases
Disease
Overweight
Body Weight
Pathologic Processes