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

Obesity Clinical Trial

— I-D-HEALTH  

Official title:

Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435603
• Other study ID #: STU00056501
• Secondary ID: R18DK083941
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: March 27, 2018
• Start date: August 2011
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Disease
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Hyperglycemia
• Metabolic Diseases
• Nutrition Disorders
• Obesity
• Overnutrition
• Overweight
• Signs and Symptoms

Intervention

Behavioral:
• Standard Lifestyle Advice
Standard clinical education is offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
• Advice Plus Lifestyle Intervention
Standard clinical education offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.

Locations

Country	Name	City	State
United States	YMCA of Metro Chicago	Chicago	Illinois
United States	McGaw YMCA	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Body Weight	(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.	Baseline to 12 months
Secondary	Incremental Costs	The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.	6, 12, and 24 months
Secondary	Changes in Health State Utility	The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.	Baseline to 6,12, and 24 months
Secondary	Percent Change in Body Weight		Baseline to 6 and 24 months
Secondary	Percent Change in Blood Total Cholesterol		Baseline to 6, 12, and 24 months
Secondary	Percent Change in A1c		Baseline to 6, 12, and 24 months
Secondary	Percent Change in Blood Pressure		Baseline to 6, 12, and 24 months
Secondary	Percent Change in Dietary Composition		Baseline to 6, 12, and 24 months
Secondary	Percent Change in Physical Activity		Baseline to 6, 12, and 24 months