Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
I-D-HEALTH
Community Translation of a Lifestyle Intervention to Improve Health in Diabetes
2 other identifiers
interventional
331
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Aug 2011
Longer than P75 for not_applicable diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 12, 2011
CompletedFirst Posted
Study publicly available on registry
September 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
April 27, 2018
CompletedApril 27, 2018
October 1, 2016
5.1 years
September 12, 2011
March 27, 2018
March 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Incremental Costs
6, 12, and 24 months
Changes in Health State Utility
Baseline to 6,12, and 24 months
Percent Change in Body Weight
Baseline to 6 and 24 months
Percent Change in Blood Total Cholesterol
Baseline to 6, 12, and 24 months
Percent Change in A1c
Baseline to 6, 12, and 24 months
- +3 more secondary outcomes
Study Arms (2)
Standard Lifestyle Advice
ACTIVE COMPARATORPrimary 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).
Advice Plus Lifestyle Intervention
EXPERIMENTALPrimary 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- Unable or unwilling to provide informed consent
- Unable to communicate with the pertinent research study staff
- Unable to read written English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
YMCA of Metro Chicago
Chicago, Illinois, 60610, United States
McGaw YMCA
Evanston, Illinois, 60201, United States
Related Publications (2)
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.
PMID: 26611433RESULTLiss 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.
PMID: 29596950DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Over the 1 year measurement period, we experienced significant loss to follow-up in this diverse, predominantly low-income sample. We were only able to measure the primary outcome, body weight, on 257 of 331 participants at the 12 month visit.
Results Point of Contact
- Title
- Research Project Manager
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald T. Ackermann, MD, MPH
Northwestern University (Illinois)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
September 12, 2011
First Posted
September 16, 2011
Study Start
August 1, 2011
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
April 27, 2018
Results First Posted
April 27, 2018
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share