N/A
N=331
Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
Diabetes Mellitus · Hyperglycemia · Obesity · Glucose Metabolism Disorders · Metabolic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01435603 ↗Enrolled (actual)
331
Serious AEs
6.0%
Results posted
Apr 2018
Primary outcome: Primary: Percent Change in Body Weight — -0.15; -1.42 percentage of change — p=0.017
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Lifestyle Advice (Behavioral); Advice Plus Lifestyle Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Body Weight |
— | — |
| SECONDARY Incremental Costs |
— | — |
| SECONDARY Changes in Health State Utility |
— | — |
| SECONDARY Percent Change in Body Weight |
— | — |
| SECONDARY Percent Change in Blood Total Cholesterol |
— | — |
| SECONDARY Percent Change in A1c |
— | — |
| SECONDARY Percent Change in Blood Pressure |
— | — |
| SECONDARY Percent Change in Dietary Composition |
— | — |
| SECONDARY Percent Change in Physical Activity |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01435603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.