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

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