Status:
COMPLETED
Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus
Hyperglycemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 bod...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01435603
Start Date
August 1 2011
End Date
September 1 2016
Last Update
April 27 2018
Active Locations (2)
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1
YMCA of Metro Chicago
Chicago, Illinois, United States, 60610
2
McGaw YMCA
Evanston, Illinois, United States, 60201