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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RAckermann, Northwestern University
ClinicalTrials.gov Identifier:
NCT01435603
First received: September 12, 2011
Last updated: October 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Hyperglycemia
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Behavioral: Standard Lifestyle Advice
Behavioral: Advice PLUS Lifestyle Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Community Translation of a Lifestyle Intervention to Improve Health in Diabetes

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • % Change in Body Weight [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incremental Costs [ Time Frame: 6, 12, and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 6,12, and 24 months ] [ Designated as safety issue: No ]
    The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life (HRQL) questionnaire. Responses from the SF-12 are used to construct a validated numerical score (the SF-6D) that expresses global HRQL across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.

  • % Change in Body Weight [ Time Frame: Baseline to 6 and 24 months ] [ Designated as safety issue: No ]
  • % Change in Blood Total Cholesterol [ Time Frame: Baseline to 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • % Change in A1c [ Time Frame: Baseline to 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • % Change in Blood Pressure [ Time Frame: Baseline to 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • % Change in Dietary Composition [ Time Frame: Baseline to 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • % Change in Physical Activity [ Time Frame: Baseline to 6, 12, and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Lifestyle Advice
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).
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 CVD risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
Other Name: Brief Lifestyle Advice
Experimental: Advice PLUS Lifestyle Intervention
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) PLUS access to an intensive group-based lifestyle intervention offered in a community setting.
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 CVD risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
Other Name: Brief Lifestyle Advice
Behavioral: 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 CVD 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. Participants with prediabetes are offered a group-based adaption of the DPP intensive lifestyle intervention; participants with type 2 diabetes are offered a group-based adaption of the LookAHEAD intensive lifestyle intervention. Both interventions are delivered in community settings by lay instructors from the YMCA who are centrally trained by the study team.
Other Names:
  • PlanAHEAD Lifestyle Intervention
  • Intensive Lifestyle Intervention

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.

The Look AHEAD (Action for Health in Diabetes) study demonstrated the effectiveness of a structured diet and physical activity interventions achieving modest weight loss can improve lipid, blood pressure, and glycemic control for adults who have type 2 diabetes. Our intervention will integrate core components of Look AHEAD into a community-based group delivery framework and will employ formal feedback approaches to help primary providers incorporate the effects of lifestyle interventions with ongoing clinical care to optimize cardiovascular and metabolic risk factor control in diabetes.

The study will include a 2-arm, randomized comparative effectiveness trial using a 1:1 individual randomization scheme. All participants will receive standard clinical education & behavioral counseling with information about community resources to help improve cardiovascular and metabolic risk factor control through healthy eating and regular physical activity. One half of participants will receive only these basic interventions; the remainder will be allocated to also receive access to a group-based adaption of the Look AHEAD lifestyle intervention delivered in a community setting by lay group instructors who are centrally trained by experts at Northwestern University, the University of Minnesota, and the YMCA. Data collection will occur in both treatment groups at baseline, 6, 12, and 24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: SBP >180 mmHg or DBP >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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435603

Locations
United States, Illinois
YMCA of Metro Chicago
Chicago, Illinois, United States, 60610
McGaw YMCA
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Ronald T. Ackermann, MD, MPH Northwestern University (Illinois)
  More Information

No publications provided

Responsible Party: RAckermann, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01435603     History of Changes
Other Study ID Numbers: STU00056501, R18DK083941
Study First Received: September 12, 2011
Last Updated: October 2, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Northwestern University:
Prevention & Control
Hyperglycemia
Obesity
Diabetes Mellitus
Cost Benefit Analysis

Additional relevant MeSH terms:
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia
Metabolic Diseases
Nutrition Disorders
Obesity
Signs and Symptoms
Overweight
Overnutrition
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on July 24, 2014