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Lifestyle Intervention For Effective Diabetes Management

Lifestyle Intervention For Effective Diabetes Management (LIFE-DM) Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00813930
Acronym
LIFE-DM
Enrollment
50
Registered
2008-12-23
Start date
2008-11-30
Completion date
2010-07-31
Last updated
2010-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes, Lifestyle Intervention, Cardiovascular risk reduction

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.

Detailed description

Diabetes is a leading cause of cardiovascular mortality and morbidity, and is more often than not a very difficult disease for individuals to manage effectively. People with diabetes have to be committed to a self-care regimen which includes, careful monitoring of blood sugar, blood pressure, cholesterol, eating healthy, exercising, foot care and regular physical and eye check-ups. This can be quite daunting and stressful for some to undertake themselves, and is largely dependent on individual self-motivation. Family physicians assist their patients in managing their diabetes but they have significant time constraints and may not always be able to deliver the high service intensity required to reduce morbidity and/or may have inadequate access to resources to help patients positively change their self-care behaviour. Chronic disease-management programs involving home-based nursing health promotion have been shown to reduce mortality, reduce recurrent hospitalization, and improve indirect societal costs among specific subgroups of the population, including those with diabetes, however, such interventions can be costly and cumbersome to implement given the need for home-based visits. INTERxVENT is a telephone-based, individualized, chronic cardiovascular and lifestyle management program combining a formal management plan, case-managed care (through a coach/mentor), and educational modules to teach patients to modify and sustain healthy lifestyle behaviours. It is comprised of several individualized modules (e.g., diet, exercise, stress management, smoking cessation, chronic disease), which are prescribed algorithmically in accordance to a patient's individual risk profile, environmental surroundings, and behavioural readiness to change. All recommendations are according to best-practice standards and evidence-based guidelines. Nonrandomized intervention studies assessing INTERxVENT in diabetic, pre-diabetic, and metabolic syndrome populations have demonstrated significant reductions in biologically relevant measures, such as fasting glucose, glycosylated hemoglobin (HbA1c), lipids, and blood pressure. However, no randomized controlled clinical trials in these populations assessing the impact of INTERxVENT have been conducted. The proposed pilot study will evaluate the efficacy of INTERxVENT as compared with 'usual medical care' in improving cardiovascular risk-factor profiles among individuals with diabetes. In addition, to what extent a chronic disease management program will yield similar effectiveness in socio-economically disadvantaged individuals is unknown. We hypothesize that chronic disease management programs, like INTERxVENT, will result in improved intermediary biological and behavioural risk profiles for all program participants randomized to this intervention, regardless of socio-economic condition. The results of this pilot study will determine and assist in designing and ascertaining sample sizes for a larger trial, respectively, should such a trial be warranted. Additionally, such chronic disease management interventions may improve the overall health of partaking individuals and relieve strain and decrease costs within the existing health care system.

Interventions

BEHAVIORALINTERxVENT lifestyle modification program

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.

Sponsors

St. Joseph's Health Centre Toronto
CollaboratorOTHER
University Health Network, Toronto
CollaboratorOTHER
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Type 2 Diabetes * Age 18 years or older

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026