Lifestyle Intervention For Effective Diabetes Management

NCT00813930 | Unknown

• 1 other identifier: SMH-LKSKI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

Chronic disease management programs are shown to reduce mortality, recurrent hospitalizations, and improve indirect societal costs among specific subgroups of the population. INTERxVENT is one such individualized chronic cardiovascular and lifestyle management program, comprised of several individualized modules - diet, exercise, stress management, smoking cessation, chronic disease - prescribed algorithmically according to patient risk profile, environmental surroundings, and behavioural readiness-to-change. Nonrandomized studies assessing INTERxVENT in diabetic, pre-diabetic, and metabolic syndrome populations have demonstrated improvement in several intermediary endpoints, including reductions in fasting glucose, lipids, and blood pressure. However, no randomized controlled clinical trials in these populations have been conducted. This pilot study is a randomized clinical trial evaluating the effectiveness of INTERxVENT as compared with 'usual medical care' in improving cardiovascular risk-factor profiles among individuals with diabetes. Additionally, the extent to which such findings are generalizable to diabetic, socially vulnerable, populations is unknown, thus this will be examined also.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Lifestyle Intervention; Cardiovascular risk reduction

Outcome Measures

Primary Outcomes (1)

• Six-month United Kingdom Prospective Diabetes Study (UKPDS) risk engine score. The UKPDS risk engine is a validated scoring system that uses multiple clinical characteristics to predict new coronary heart disease risks in patients with type 2 diabetes.

  6 months

Secondary Outcomes (1)

• Six-month: HbA1c, seated systolic blood pressure, serum Total Cholesterol concentration, serum HDL-C concentration, Total/HDL-C ratio value, LDL-C concentration, self-reported smoking status, adherence to medications and lifestyle measures.

  6 months

Study Arms (2)

INTERxVENT Program

EXPERIMENTAL

Participants in INTERxVENT will complete a 'Baseline Assessment' and 'Follow-up' questionnaire, and will have a health professional visit his/her home for an initial assessment (BP,height,weight,waist measurement) and blood collection (blood glucose and cholesterol levels). As part of the program, each participant will also complete a self-reported 'Health History Questionnaire' (HHQ); a follow-up HHQ will be completed about 12 weeks into the program to monitor progress. Each participant randomized to INTERxVENT receives educational articles which address diabetes management issues. A structured, individualized program, consisting of educational materials and 12 live mentoring/coaching telephone calls will take place over 6 months. The mentors consist of allied health professionals. The sequence by which educational content is administered will be both self-directed and guided by the mentors using an algorithmic approach according to the participant's readiness-to-change scores.

Behavioral: INTERxVENT lifestyle modification program

Usual medical care

NO INTERVENTION

Each participant randomized to this group will not receive any formal intervention but will receive the same care over the 6-month period as he/she usually receives from his/her health care team. Participants in this group will undergo the same baseline and outcome assessment as those in the intervention group, including blood pressure (BP) measurement, physical assessment (height, weight, waist measurement) and blood collection (blood glucose and cholesterol levels), as well as completion of the 'Baseline Assessment' and 'Follow-up' questionnaires.

Interventions

INTERxVENT lifestyle modification program BEHAVIORAL

It is a lifestyle behavior modification program which helps Type 2 diabetics manage diabetes better and reduce cardiovascular risk factors. The program involves up to 12 telephone mentor/coaching sessions with a certified health professional.

Also known as: INTERxVENT

INTERxVENT Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes
• Age 18 years or older

You may not qualify if:

• Documented history of myocardial infarction, stroke, angina, angioplasty, or bypass surgery
• Unable to understand written and spoken English
• Presence of cognitive impairment (e.g., dementia) or significant psychological problems (e.g., schizophrenia, schizoaffective disorders) that, in the investigators' opinion, may prohibit the participant from following study protocols
• Unavailable to participate (e.g., incarceration, no access to a telephone)
• HIV / AIDS
• Estimated life expectancy less than one year in the opinion of the clinician
• Participation in any other clinical study

Sponsors & Collaborators

• Unity Health Toronto: lead
• St. Joseph's Health Centre Toronto: collaborator
• University Health Network, Toronto: collaborator

Study Sites (3)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

Related Publications (12)

• Booth GL, Kapral MK, Fung K, Tu JV. Recent trends in cardiovascular complications among men and women with and without diabetes. Diabetes Care. 2006 Jan;29(1):32-7. doi: 10.2337/diacare.29.01.06.dc05-0776.

  PMID: 16373892 BACKGROUND

• Booth GL, Kapral MK, Fung K, Tu JV. Relation between age and cardiovascular disease in men and women with diabetes compared with non-diabetic people: a population-based retrospective cohort study. Lancet. 2006 Jul 1;368(9529):29-36. doi: 10.1016/S0140-6736(06)68967-8.

  PMID: 16815377 BACKGROUND

• Simpson SH, Corabian P, Jacobs P, Johnson JA. The cost of major comorbidity in people with diabetes mellitus. CMAJ. 2003 Jun 24;168(13):1661-7.

  PMID: 12821619 BACKGROUND

• Bonow RO, Gheorghiade M. The diabetes epidemic: a national and global crisis. Am J Med. 2004 Mar 8;116 Suppl 5A:2S-10S. doi: 10.1016/j.amjmed.2003.10.014.

  PMID: 15019858 BACKGROUND

• Buhrmann R, Asaad D, Hux JE, Tang M, Sykora K: Diabetes and the Eye. In Diabetes in Ontario: an ICES practice atlas. Hux JE, Booth GL, Slaughter P, Laupacis A, Eds. Toronto, Institute for Clinical Evaluative Sciences, 2003.

  BACKGROUND

• Shah BR, Mamdani M, Kopp A: Drug Use in Older People with Diabetes. In Diabetes in Ontario: an ICES practice atlas. Hux JE, Booth GL, Slaughter P, Laupacis A, Eds. Toronto, Insitute for Clinical Evaluative Sciences, 2003.

  BACKGROUND

• Markle-Reid M, Weir R, Browne G, Roberts J, Gafni A, Henderson S. Health promotion for frail older home care clients. J Adv Nurs. 2006 May;54(3):381-95. doi: 10.1111/j.1365-2648.2006.03817.x.

  PMID: 16629922 BACKGROUND

• Markle-Reid M, Browne G, Weir R, Gafni A, Roberts J, Henderson SR. The effectiveness and efficiency of home-based nursing health promotion for older people: a review of the literature. Med Care Res Rev. 2006 Oct;63(5):531-69. doi: 10.1177/1077558706290941.

  PMID: 16954307 BACKGROUND

• Gordon NF, Salmon RD, Mitchell BS, Faircloth GC, Levinrad LI, Salmon S, Saxon WE, Reid KS. Innovative approaches to comprehensive cardiovascular disease risk reduction in clinical and community-based settings. Curr Atheroscler Rep. 2001 Nov;3(6):498-506. doi: 10.1007/s11883-001-0040-9.

  PMID: 11602070 BACKGROUND

• Gordon NF, English CD, Contractor AS, Salmon RD, Leighton RF, Franklin BA, Haskell WL. Effectiveness of three models for comprehensive cardiovascular disease risk reduction. Am J Cardiol. 2002 Jun 1;89(11):1263-8. doi: 10.1016/s0002-9149(02)02323-8.

  PMID: 12031725 BACKGROUND

• Gordon NF, Salmon RD, Franklin BA, Sperling LS, Hall L, Leighton RF, Haskell WL. Effectiveness of therapeutic lifestyle changes in patients with hypertension, hyperlipidemia, and/or hyperglycemia. Am J Cardiol. 2004 Dec 15;94(12):1558-61. doi: 10.1016/j.amjcard.2004.08.039.

  PMID: 15589017 BACKGROUND

• Stevens RJ, Kothari V, Adler AI, Stratton IM; United Kingdom Prospective Diabetes Study (UKPDS) Group. The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56). Clin Sci (Lond). 2001 Dec;101(6):671-9.

  PMID: 11724655 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gillian L. Booth, MD, MSc

  Li Ka Shing Knowledge Institute, St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 23, 2010

Record last verified: 2010-03

Locations

CA (3)