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Completed

NCT Number: NCT01435603

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

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.

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Key information

Conditions

Diabetes Mellitus Body Weight Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YMCA of Metro Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older, AND
  • Body-mass index of ≥ 24 kg/m2, AND
  • 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:

  • 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
  • Lung disease:
  • Chronic obstructive airways disease or asthma requiring home oxygen
  • Pregnancy
  • Any other known condition that could limit ability to become physically active or limit life span to <5 years

Exclusions related to metabolism:

  • Use of medications known to produce hyperglycemia
  • 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:

  • Unable or unwilling to provide informed consent
  • Unable to communicate with the pertinent research study staff
  • Unable to read written English or Spanish

Treatment and study plan

Standard Lifestyle Advice

Behavioral

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 names: Brief Lifestyle Advice

Advice Plus Lifestyle Intervention

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

Acronym: I-D-HEALTH

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2011
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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