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

Northwestern University

Status: Completed

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

Treatments: Behavioral: Advice Plus Lifestyle Intervention; Behavioral: Standard Lifestyle Advice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01435603

R18DK083941 (U.S. NIH Grant/Contract)

STU00056501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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331 participants in 2 patient groups

Standard Lifestyle Advice

Active Comparator group

Description:

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).

Treatment:

Behavioral: Standard Lifestyle Advice

Advice Plus Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Lifestyle Advice

Behavioral: Advice Plus Lifestyle Intervention