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

Not Applicable

Completed

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

Interventions: Behavioral: Standard Lifestyle Advice
Behavioral: Advice Plus Lifestyle Intervention

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.

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.

Recruitment & Eligibility

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:

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Advice Plus Lifestyle Intervention	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) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
Advice Plus Lifestyle Intervention	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.
Standard Lifestyle Advice	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).

Primary Outcome Measures

Name	Time	Method
Percent Change in Body Weight	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

Name	Time	Method
Changes in Health State Utility	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.
Incremental Costs	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.
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