MedTrace Logo

Lifestyle Intervention For Effective Diabetes Management

NCT00813930 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-03-23

No results posted yet for this study

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

Interventions

BEHAVIORAL

INTERxVENT 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 & Collaborators

  • St. Joseph's Health Centre Toronto

    collaborator OTHER

  • University Health Network, Toronto

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Gillian L. Booth, MD, MSc · Li Ka Shing Knowledge Institute, St. Michael's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813930 on ClinicalTrials.gov