Diabetes MellitusI-D-HEALTHNCT01435603
Intervening in Diabetes With Healthy Eating, Activity, and Linkages To Healthcare - The I-D-HEALTH Study
A study testing Standard Lifestyle Advice and Advice Plus Lifestyle Intervention in people with Diabetes Mellitus and Hyperglycemia, run by Northwestern University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hyperglycemia, Obesity
- What is being tested?
- Standard Lifestyle Advice and Advice Plus Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
YMCA of Metro Chicago
Chicago, Illinois, 60610
McGaw YMCA
Evanston, Illinois, 60201
About this study
Official title: Community Translation of a Lifestyle Intervention to Improve Health in Diabetes
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hyperglycemia, Obesity, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
- Being tested
- Standard Lifestyle Advice, Advice Plus Lifestyle Intervention
- Keywords
- Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Obesity, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Overnutrition, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Lifestyle AdviceBehavioural
Also called Brief 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 InterventionBehavioural
Also called Plan Ahead Lifestyle Intervention, Intensive 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Lifestyle Advice | Active comparator | 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). Receives: Behavioral: Standard Lifestyle Advice |
| Advice Plus Lifestyle Intervention | Experimental | 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. Receives: Behavioral: Standard Lifestyle Advice; Behavioral: Advice Plus Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (8)
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.
Measured: 6, 12, and 24 months
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.
Measured: Baseline to 6,12, and 24 months
Percent Change in Body Weight
Measured: Baseline to 6 and 24 months
Percent Change in Blood Total Cholesterol
Measured: Baseline to 6, 12, and 24 months
Percent Change in A1c
Measured: Baseline to 6, 12, and 24 months
Percent Change in Blood Pressure
Measured: Baseline to 6, 12, and 24 months
Percent Change in Dietary Composition
Measured: Baseline to 6, 12, and 24 months
Percent Change in Physical Activity
Measured: Baseline to 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Ackermann, Northwestern University
- Investigators
- Ronald T. Ackermann, MD, MPH, Principal investigator, Northwestern University (Illinois)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435603
- Sponsor's protocol ID
- STU00056501
- Other IDs
- R18DK083941
- Acronym
- I-D-HEALTH
- Status last verified
- Oct 2016
- First submitted
- 12 Sep 2011
- Last updated
- 27 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26611433Liss 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.
PubMed 29596950
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Translation of a Lifestyle Intervention to Improve Health in Diabetes
- ClinicalTrials.gov ID
- NCT01435603
- Acronym / sponsor ID
- I-D-HEALTH / STU00056501
- Conditions
- Diabetes Mellitus, Hyperglycemia, Obesity, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
- Keywords
- Prevention & Control, Hyperglycemia, Obesity, Diabetes Mellitus, Cost Benefit Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Posted 27 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Lifestyle Advice | Active comparator | Behavioral: Standard Lifestyle AdvicePrimary 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 | Experimental | Behavioral: Standard Lifestyle Advice, Behavioral: Advice Plus Lifestyle InterventionPrimary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention:
- Significant cardiovascular disease:
- Lung disease:
- Pregnancy
- Any other known condition that could limit ability to become physically active or limit life span to <5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Lifestyle AdviceAlso: Brief Lifestyle AdviceStandard 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. | Behavioural | Advice Plus Lifestyle Intervention, Standard Lifestyle Advice |
| Advice Plus Lifestyle InterventionAlso: Plan Ahead Lifestyle Intervention, Intensive Lifestyle InterventionStandard 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. | Behavioural | Advice Plus Lifestyle Intervention |
Primary outcome
Percent Change in Body Weight
Time frame: Baseline to 12 months
(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.
8 secondary outcomes
Incremental Costs
Time frame: 6, 12, and 24 months
Changes in Health State Utility
Time frame: Baseline to 6,12, and 24 months
Percent Change in Body Weight
Time frame: Baseline to 6 and 24 months
Percent Change in Blood Total Cholesterol
Time frame: Baseline to 6, 12, and 24 months
Percent Change in A1c
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Blood Pressure
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Dietary Composition
Time frame: Baseline to 6, 12, and 24 months
Percent Change in Physical Activity
Time frame: Baseline to 6, 12, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26611433Liss 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.
- Derived from this study: PubMed 29596950Liss 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald T. Ackermann, MD, MPH principal investigator
Northwestern University (Illinois)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Lifestyle Advice and Advice Plus Lifestyle Intervention in people with Diabetes Mellitus and Hyperglycemia, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Body Weight (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.