Alberta Diabetes and Physical Activity Trial

Type 2 Diabetes Clinical Trial

Official title:

The Development and Evaluation of Physical Activity Behavioural Strategies for Adults With Type 2 Diabetes: A Population Based Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221234
• Other study ID #: MOP-69070
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: March 13, 2009
• Start date: September 2005
• Est. completion date: July 2007

Study information

• Verified date: March 2009
• Source: University of Alberta, Physical Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

This project will assess the incremental and cumulative impact of three behavioural intervention strategies for the promotion of physical activity in the adult general population with Type 2 diabetes.

Description:

An increasing prevalence of Type 2 Diabetes is associated with the aging population, a significant rise in the prevalence of obesity, and a sedentary lifestyle. In Canada, 4.9-7.0% over the age of 12 and 17% over the age of 64 are estimated to have diabetes, 90-95% of which will be Type 2. Strong evidence supports the importance of physical activity in the management of Type 2 Diabetes. However, current literature lacks clear understanding of best strategies for physical activity behaviour change in this target population. Existing studies employ resource intensive, one-to-one individual and clinically-based approaches with limited theoretical grounding for recommended health behaviour change. Most fail to offer practical, sustainable, economically viable solutions, with documented long-term intervention efficacy. The call to move beyond the clinical focus by including theoretically population-based and "real-life" approaches for the management Type 2 Diabetes remains largely unheeded. The three interventions are: (1) standard print-based physical activity educational materials provided by the Canadian Diabetes Association (CDA); (2) CDA materials + pedometers and a log book + theoretical stage-matched print-based physical activity materials; and, (3) the same as intervention 2 with the addition of a 12-month physical activity telephone counseling protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

>18 years old, Type 2 Diabetes, Living in the province of Alberta, Can communicate in English.

Exclusion Criteria:

Serious Contraindications to Physical Activity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Print materials, pedometers/logbooks

• Print materials, pedometers/logbooks, telephone counselling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta, Physical Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Behaviour
Secondary	HbA1c, CRP, lipid concentrations, fasting blood glucose, insulin, health related quality of life, psychosocial predictors of physical activity.