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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

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

Intervention / Treatment
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* Behavioral: Standard Lifestyle Advice
* Behavioral: Advice Plus Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Lifestyle Advice<br>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<br>* 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.<br>* Other names: Brief Lifestyle Advice;|
| Experimental: Advice Plus Lifestyle Intervention<br>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<br>* 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.<br>* Other names: Brief Lifestyle Advice;Behavioral: Advice Plus Lifestyle Intervention<br>* 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.<br>* Other names: Intensive Lifestyle Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Body Weight | (Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Costs | 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. | 6, 12, and 24 months | 
| Changes in Health State Utility | 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. | Baseline to 6,12, and 24 months | 
| Percent Change in Body Weight |  | Baseline to 6 and 24 months | 
| Percent Change in Blood Total Cholesterol |  | Baseline to 6, 12, and 24 months | 
| Percent Change in A1c |  | Baseline to 6, 12, and 24 months | 
| Percent Change in Blood Pressure |  | Baseline to 6, 12, and 24 months | 
| Percent Change in Dietary Composition |  | Baseline to 6, 12, and 24 months | 
| Percent Change in Physical Activity |  | Baseline to 6, 12, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis