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

Primary Purpose

Diabetes Mellitus, Hyperglycemia, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Lifestyle Advice

Advice Plus Lifestyle Intervention

About this trial

This is an interventional supportive care trial for Diabetes Mellitus focused on measuring Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

YMCA of Metro Chicago
McGaw YMCA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Lifestyle Advice

Advice Plus Lifestyle Intervention

Arm Description

Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Percent Change in Body Weight

Percent Change in Blood Total Cholesterol

Percent Change in A1c

Percent Change in Blood Pressure

Percent Change in Dietary Composition

Percent Change in Physical Activity

Full Information

NCT ID

NCT01435603

First Posted

September 12, 2011

Last Updated

March 27, 2018

Sponsor

Northwestern University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01435603

Brief Title

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

Acronym

I-D-HEALTH

Official Title

Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

331 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Lifestyle Advice

Arm Type

Active Comparator

Arm Description

Arm Title

Advice Plus Lifestyle Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Standard Lifestyle Advice

Other Intervention Name(s)

Brief Lifestyle Advice

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Advice Plus Lifestyle Intervention

Other Intervention Name(s)

Plan Ahead Lifestyle Intervention, Intensive Lifestyle Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent Change in Body Weight

Description

(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.

Time Frame

Baseline to 12 months

Secondary Outcome Measure Information:

Title

Incremental Costs

Description

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.

Time Frame

6, 12, and 24 months

Title

Changes in Health State Utility

Description

Time Frame

Baseline to 6,12, and 24 months

Title

Percent Change in Body Weight

Time Frame

Baseline to 6 and 24 months

Title

Percent Change in Blood Total Cholesterol

Time Frame