Diabetes Mellitus, Type 2ICANNCT00717158
Lifestyle Intervention's Impact on Health Care Costs
A study testing Usual medical care and Lifestyle Case management in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Virginia at 1 site in United States.
Trial summary
The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Usual medical care and Lifestyle Case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Feb 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 30 kg/m2, calculated from measured weight and height.
- Type 2 diabetics on medication for their diabetes.
- Age 20 -60 years of age.
- Have phone.
- Fluency in reading, writing and comprehension of English
- Have Qualchoice as their primary health insurer.
Who cannot join
- Depression, BDI score > 20
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
About this study
Official title: Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study
The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (> 5-10%), improvement in diet quality and an increase in physical activity.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Usual medical care, Lifestyle Case management
- Keywords
- Health Behavior, Lifestyle, health care costs, quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual medical careBehavioural
Lifestyle Case managementBehavioural
Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in
| Study group | Role | What they receive |
|---|---|---|
| I | No intervention | Usual medical care. They received written healthy lifestyle information Receives: Behavioral: Usual medical care |
| 2 | Active comparator | Intervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in Receives: Behavioral: Lifestyle Case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Care utilization and costs using claims data
Measured: one year
Secondary outcomes (5)
Weight change
Measured: one year
Change in hemoglobin A1c
Measured: One Year
Work days lost
Measured: One year
Disability Days
Measured: One year
Change in quality of life
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMay 2001
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Anne M Wolf, MS, RD, Principal investigator, University of Virginia School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717158
- Sponsor's protocol ID
- 8742
- Other IDs
- Am Dietetic Assoc 9336
- Acronym
- ICAN
- Status last verified
- Aug 2007
- First submitted
- 14 Jul 2008
- Last updated
- 16 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolf AM, Conaway MR, Crowther JQ, Hazen KY, L Nadler J, Oneida B, Bovbjerg VE; Improving Control with Activity and Nutrition (ICAN) Study. Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Diabetes Care. 2004 Jul;27(7):1570-6. doi: 10.2337/diacare.27.7.1570.
PubMed 15220230Wolf AM, Siadaty M, Yaeger B, Conaway MR, Crowther JQ, Nadler JL, Bovbjerg VE. Effects of lifestyle intervention on health care costs: Improving Control with Activity and Nutrition (ICAN). J Am Diet Assoc. 2007 Aug;107(8):1365-73. doi: 10.1016/j.jada.2007.05.015.
PubMed 17659904
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Healthcare Utilization, Costs and Health-Related Outcomes of a Medical Nutrition Therapy Intervention on Obese Patients With Type 2 Diabetes - A Pilot Study
- ClinicalTrials.gov ID
- NCT00717158
- Acronym / sponsor ID
- ICAN / 8742
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- Health Behavior, Lifestyle, health care costs, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2001
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ICAN Pilot project aims to evaluate the differences in economic, clinical and quality of life outcomes of a nutrition intervention involving lifestyle case management and medical nutrition therapy by a registered dietitian compared to usual medical care in obese persons with type 2 diabetes. The intervention is aimed at moderate weight loss (> 5-10%), improvement in diet quality and an increase in physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | No intervention | Behavioral: Usual medical careUsual medical care. They received written healthy lifestyle information |
| 2 | Active comparator | Behavioral: Lifestyle Case managementIntervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI > 30 kg/m2, calculated from measured weight and height.
- Type 2 diabetics on medication for their diabetes.
- Age 20 -60 years of age.
- Have phone.
- Fluency in reading, writing and comprehension of English
Key exclusion criteria (2 listed)
- Depression, BDI score > 20
- Pregnancy
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 |
|---|---|---|
| Usual medical care | Behavioural | I |
| Lifestyle Case managementIntervention participants were assigned to one registered dietitian who they met with over a one year period for 6 session (four hours) of individual care, 6- one-hour group classes, and had monthly email contact for follow up and checking in | Behavioural | 2 |
Primary outcome
Health Care utilization and costs using claims data
Time frame: one year
5 secondary outcomes
Weight change
Time frame: one year
Change in hemoglobin A1c
Time frame: One Year
Work days lost
Time frame: One year
Disability Days
Time frame: One year
Change in quality of life
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2008.
- Results publication: PubMed 15220230Wolf AM, Conaway MR, Crowther JQ, Hazen KY, L Nadler J, Oneida B, Bovbjerg VE; Improving Control with Activity and Nutrition (ICAN) Study. Translating lifestyle intervention to practice in obese patients with type 2 diabetes: Improving Control with Activity and Nutrition (ICAN) study. Diabetes Care. 2004 Jul;27(7):1570-6. doi: 10.2337/diacare.27.7.1570.
- Results publication: PubMed 17659904Wolf AM, Siadaty M, Yaeger B, Conaway MR, Crowther JQ, Nadler JL, Bovbjerg VE. Effects of lifestyle intervention on health care costs: Improving Control with Activity and Nutrition (ICAN). J Am Diet Assoc. 2007 Aug;107(8):1365-73. doi: 10.1016/j.jada.2007.05.015.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Anne M Wolf, MS, RD principal investigator
University of Virginia School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual medical care and Lifestyle Case management in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Virginia at 1 site 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 6 inclusion and 2 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 16 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Health Care utilization and costs using claims data (time frame: one year). 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 NCT00717158, 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 16 Jul 2008.