Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Hyperglycemia, Obesity, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Overnutrition, Nutrition Disorders, Overweight, Body Weight, Signs and Symptoms
In brief
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.
Key facts
- Study ID
- NCT01435603
- Run by
- Northwestern University
- People needed
- 331
- Starts
- 2011-08-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-04-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- YMCA of Metro Chicago — Chicago, Illinois, United States
- McGaw YMCA — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.