Lifestyle Therapy for Youth With Type 2 Diabetes

NCT ID: NCT01597154

Last Updated: 2014-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-05-31

Brief Summary

Background: Little is known about the efficacy of intensive lifestyle therapy (i.e. increased physical activity and dietary changes) for the management of glycemia and cardiometabolic risk factors in children and adolescents with type 2 diabetes (T2DM).

Our hypothesis is that education regarding healthy lifestyle changes will significantly reduce blood sugars in youth with T2DM that do not require insulin therapy. Our secondary hypothesis is that the intensive lifestyle therapy will cause quick and sustained reductions in health risk measured by body mass index (BMI), blood pressure, waist circumference, LDL cholesterol, serum triglycerides and apolipoprotein B.

Detailed Description

Youth between the ages of 10-20 years living with type 2 diabetes and not currently on insulin therapy will be randomly assigned to either a lifestyle intervention group or a control group. The lifestyle intervention group will meet 2-3 times per week for 16 weeks to take part in healthy living education sessions involving physical activity, healthy cooking, healthy gardening and how to start and sustain a healthy lifestyle change. At the beginning and end of the 16 weeks the investigators will measure the participants' blood sugars, height, weight, cholesterol, triglycerides and liver enzymes. The investigators will also take a picture of their kidney, heart and blood vessels using ultrasound. Those youth assigned to the control group will receive the 16 week intervention following their 16 week control period.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle counselling

Exercise, nutrition and self-efficacy based lifestyle training in a peer mentoring setting

Group Type: EXPERIMENTAL

Lifestyle Counselling

Intervention Type: BEHAVIORAL

Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices

Control

Youth randomized to the control group will receive standard care for the first 16 weeks followed by 16 weeks of intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle Counselling

Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• youth with a BMI considered overweight according to the International Obesity Task Force
• diagnosed with type 2 diabetes, confirmed with a 2-hour oral glucose tolerance test within two years of enrollment

Exclusion Criteria

• youth with type 1 diabetes
• use of insulin or other anti-diabetic drugs
• youth with medication-induced diabetes
• youth who have recently been admitted to hospital with ketoacidosis
• youth have experienced weight loss or enrolled in a weightloss program in the last 6 months
• youth with an orthapaedic injury preventing them from exercising
• youth who have a history of alcohol or drug abuse

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manitoba Institute of Child Health

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Jon McGavock

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathon McGavock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Manitoba Institute of Child Health

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2012:023

Identifier Type: -

Identifier Source: org_study_id