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INTERxVENT Program for Type 2 Diabetes (LIFE-DM Trial)

N/A
Waitlist Available
Led By Gillian L. Booth, MD, MSc
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

LIFE-DM Trial 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.

Eligible Conditions
  • Type 2 Diabetes

LIFE-DM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.
Secondary outcome measures
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.

LIFE-DM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: INTERxVENT ProgramExperimental Treatment1 Intervention
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.
Group II: Usual medical careActive Control1 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.

Find a Location

Who is running the clinical trial?

St. Joseph's Health Centre TorontoOTHER
2 Previous Clinical Trials
76 Total Patients Enrolled
Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,715 Total Patients Enrolled
University Health Network, TorontoOTHER
1,473 Previous Clinical Trials
484,955 Total Patients Enrolled

Frequently Asked Questions

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~3 spots leftby Apr 2025