The OnTrack Diabetes Web-based Program for Type 2 Diabetes and Dysphoria Self-Management: A Randomised Controlled Trial

Not Applicable

• Conditions: Type 2 diabetes; Dysphoria; Public Health - Health promotion/education; Mental Health - Other mental health disorders; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12614001126606
• Lead Sponsor: Queensland University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

(a) Type 2 diabetes diagnosis (by a medical doctor and/ according to WHO criteria) for 3 or more months; (b) aged 18 years or older; (c) living in Australia without plans to leave within 12 months; (d) regular computer and internet access ; (e) contactable by phone; (f) clear command of written English (at least year 5 education); and (g) stable diabetes pharmacotherapy (medication dose stable for past 4 weeks; medication type stable past 3 months).

Exclusion Criteria

(a) current diagnosis of mental disorder other than depression or anxiety (participant is asked if a condition has been diagnosed and if so they are informed that they will receive access to the program but not be included in the trial); (b) current suicidal risk (assessed via suicide risk assessment); (c) significant cognitive disorder (e.g. from head trauma or dementia); (d) currently on steroid medication , or likely to commence these in the next 12 months; (e) pregnant or likely to become pregnant in the next 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence behaviours (assessed using questionnaires - Serves of fruit, vegetables, sweets, and fat per week (new survey designed for OnTrack Diabetes to assess diet), Active Australia Survey (physical activity), AusDiab Study Survey (medication + blood sugar testing)[Baseline, 3, 6 months];Mental health (assessed by questionnaires - Depression, Anxiety, Stress Scale; Diabetes Distress Scale)[Baseline, 3 and 6 months]

Secondary Outcome Measures

Name	Time	Method
HbA1c (assessed by blood sample from their GP)[Baseline, 3, and 6 months];Quality of Life (EQ-5D)[baseline, 3, 6 months];Self Efficacy (Diabetes Self-Efficacy Scale)[Baseline, 3, 6 months]