Clinical trial NCT01435603: Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
Official title: Community Translation of a Lifestyle Intervention to Improve Health in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hyperglycemia
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Keywords: Prevention & Control
Hyperglycemia
Obesity
Diabetes Mellitus
Cost Benefit Analysis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-09-16
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility 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

Primary outcomes:
measure: Percent Change in Body Weight
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Incremental Costs
timeFrame: 6, 12, and 24 months
measure: Changes in Health State Utility
timeFrame: Baseline to 6,12, and 24 months
measure: Percent Change in Body Weight
timeFrame: Baseline to 6 and 24 months
measure: Percent Change in Blood Total Cholesterol
timeFrame: Baseline to 6, 12, and 24 months
measure: Percent Change in A1c
timeFrame: Baseline to 6, 12, and 24 months
measure: Percent Change in Blood Pressure
timeFrame: Baseline to 6, 12, and 24 months
measure: Percent Change in Dietary Composition
timeFrame: Baseline to 6, 12, and 24 months
measure: Percent Change in Physical Activity
timeFrame: Baseline to 6, 12, and 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: YMCA of Metro Chicago
state: Illinois
city: Evanston
country: United States
facility: McGaw YMCA
state: Illinois
Study officials:
affiliation: Northwestern University (Illinois)
name: Ronald T. Ackermann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liss DT, Finch EA, Gregory DL, Cooper A, Ackermann RT. Design and participant characteristics for a randomized effectiveness trial of an intensive lifestyle intervention to reduce cardiovascular risk in adults with type 2 diabetes: The I-D-HEALTH study. Contemp Clin Trials. 2016 Jan;46:114-121. doi: 10.1016/j.cct.2015.11.016. Epub 2015 Dec 2.
citation: Liss DT, Finch EA, Cooper A, Sheth A, Tejuosho AD, Lancki N, Ackermann RT. One-year effects of a group-based lifestyle intervention in adults with type 2 diabetes: A randomized encouragement trial. Diabetes Res Clin Pract. 2018 Jun;140:36-44. doi: 10.1016/j.diabres.2018.03.030. Epub 2018 Mar 27.