The development of OnTrack Diabetes is described in a companion paper [62](see Figure 1 for screenshot). The program targets physical activity participation, nutrition, adherence to health routines, and mood disturbance (depression, anxiety, and diabetes-related everyday stressors). Specifically, the program includes informational resources: goal setting, planning, and creating routines for self-care behaviors; feeling confident and problem solving via interactive tools; goal attainment scaling via self-monitoring tools, quizzes, and automated feedback graphs; relaxation and mindfulness audios; and an electronic diary. Access to health care providers is also promoted by encouraging users to establish a diabetes care team. Further, the program addresses the independent effects of depression, anxiety, and diabetes-specific distress by enabling users to provide personalized responses in the emotional support tools regarding both diabetes-specific and nonspecific emotional challenges. Although program sections appear in an ordered structure, users can choose to undertake segments in any order—a feature intended to foster user empowerment [63]. Both provided and entered text is minimized with extensive use of icons and pictures and simple sentences and vocabulary so that reading requirements do not exceed Year 7 educational levels.

A pilot trial of the program is initially implemented to test for program functionality and to provide an indication of program efficacy, user acceptability, and satisfaction. Following the pilot, a RCT with the participant as the unit of randomization is implemented. The trial is conducted Australia-wide and access is ongoing. The research team is based at the Mitsubishi Centre for Rural and Remote Health at the Wesley Research Institute in Brisbane.

The RCT evaluates the efficacy of the OnTrack Diabetes program in improving the primary outcomes glycemic control (HbA_1c level) and diabetes-specific distress symptoms, and the secondary outcomes of depression, anxiety, physical activity participation, diet, blood glucose self-monitoring, and medication taking. User acceptability, ease of use, utility, program satisfaction, and implementation feasibility are also assessed.

It is hypothesized that at 3 months postbaseline, the immediate access plus FIT condition will show the greatest improvements in primary and secondary outcomes compared with the immediate access and the delayed access conditions. Results of the immediate access and the delayed access conditions are expected to be similar at 6 months when both conditions will have received the full intervention. A CONSORT flow diagram for the trial is shown in Figure 2.

Recruitment strategies for the trial are primarily community-based: newspaper advertisements, health organization newsletters, radio broadcasts, notice board postings, bulletins, emails, and online advertisements. Targeted methods include the distribution of study flyers and posters to medical centers, letters to health institutions, pharmacies and health professionals, and featuring the OnTrack Diabetes website URL on statewide Diabetes Australia research Web pages. Attendance at diabetes-related expos and events allows in-person recruitment and further promotion of the project to health professionals.

The trial aims to enroll at least 210 participants. Selection criteria include (1) type 2 diabetes diagnosis (by a medical doctor and according to World Health Organization criteria) of at least 3 months duration, (2) age 18 years or older, (3) living in Australia without plans to leave within 12 months, (4) regular computer and Internet access, (5) contactable by phone, (6) clear command of written English (at least Year 5 education), and (7) stable diabetes pharmacotherapy (medication dose stable ≥4 weeks; medication type stable ≥3 months). Study exclusion criteria include (1) 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), (2) current suicidal risk (assessed via suicide risk assessment), (3) significant cognitive disorder (eg, from head trauma or dementia), (4) currently on steroid medication or likely to commence it in the next 12 months, and (5) pregnant or likely to become pregnant in the next 12 months.

All participants are asked to undertake a medical assessment by their general practitioner prior to study enrollment. Individuals with physical limitations or concurrent physical disorders are advised of the need to exercise caution in setting physical activity goals according with their doctor’s advice.

Primary outcomes include diabetes self-care behaviors, HbA_1c level, and diabetes-specific distress. Secondary outcomes include depression, anxiety, (medication taking, nutrition intake, physical activity, and blood glucose self-monitoring), quality of life, and user evaluations of the program. Measures are administered at baseline and the 3-, 6-, and 12-month follow-up time points. Table 1 in Multimedia Appendix 1 lists the measures.

Participants register interest on the study website and select a time to undertake an eligibility screening appointment by phone. Eligible individuals undertake baseline measures by email and phone interview at their selected appointment time. Individuals who satisfy all criteria except inclusion criterion time since diagnosis or stable medication are asked if they wish to be recontacted for future screening; if so, they are categorized as “pending.” Individuals who are ineligible are allowed to use the program without being enrolled in the trial.

Following baseline measures, all participants who are randomly allocated to the immediate access or the immediate access plus FIT interventions receive a secure username and password with which to log on to the program. Those enrolled in the delayed access condition are informed that they will receive program access details in 3 months. Computer-generated randomization occurs automatically. One week before the due date for follow-up study measures, participants receive an email notification with a link to the online survey and a preset time for the timeline follow-back procedure phone interview. The email requests that participants email the researcher if the phone interview time does not suit them.

In this condition, participants undertake their usual diabetes care with no Web-based program access. Following 3-month follow-up study measures, they receive access to the full OnTrack Diabetes program. Their access to the program is actioned by a member of the research team after which they receive an email that contains an exclusive username and password to access the program.

Participants receive access to the full OnTrack Diabetes program from baseline as described in the companion paper about the development of OnTrack Diabetes [62]. This includes access to extensive information resources, a nutrition module (Eating Well and Feeling Healthy), a module focused on adherence to health regimens (Health Routines), an emotional well-being module (Thinking Well and Feeling Fine), and a maintenance module (Keeping On Track). The first section of each module includes a series of interactive tools that incorporate guided imagery, planning goal implementation, goal setting, and confidence building. The planning tools guide participants in proceeding toward their own personalized goals in incremental steps. The second section of each module is entitled “More on...” (eg, More on Health Routines) and involves setting a weekly schedule to increase participation in desired health behaviors and pleasurable activities, and tools for problem-solving challenges. A printable summary is provided on completion of each interactive tool. These summaries can be accessed on future occasions and participants can also complete tools or modules repeatedly if they wish. Self-monitoring tools allow daily monitoring of highest and lowest blood glucose levels, best and worst mood, and the degree that physical activity and nutrition goals were met. Automated feedback graphs on progress are provided for the past week, month, or 3 months. Mindfulness audios are playable on the computer or can be downloaded to an MP3 player.

In addition to content received in the immediate access condition, participants in this condition receive regular therapist support phone calls wherein FIT techniques are utilized. The therapist is a provisionally registered psychologist who contacts participants twice in the first week of study enrollment and once in the second and third week of enrollment followed by biweekly calls. Calls last for an average of 30 to 40 minutes until the participant has been enrolled for 1 month, after which they last approximately 20 minutes. Participants are encouraged to practice FIT at home every day. The approach assists them to develop and maintain personalized changes to their diabetes self-care behaviors, alcohol use, smoking, or lifestyle. The therapist reinforces the imagery-based activities already included in the OnTrack Diabetes program and extends these by encouraging additional imagery rehearsal to further enhance motivation.

Preliminary analyses assess for baseline differences and subsequent analyses control for any observed differences. The primary analyses will comprise multiple regressions, predicting posttreatment and follow-up results from baseline measures and treatment contrasts with multiple imputation being used to predict missing data. Mixed-model ANOVAs with repeated measures will also be applied to confirm whether effects are still obtained without imputations. Both methods allow an intention-to-treat approach to the data. Repeated measures ANOVAs will be used to evaluate differences in change scores between the study time points among the 3 study conditions.

User satisfaction, perceived ease of use, and usefulness are examined with ANOVAs and program reach, acceptability, implementation feasibility, and outreach are assessed using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework [64]. This will be operationalized using the OnTrack Diabetes Evaluation Questionnaire, which asks about users’ perceptions of the program’s acceptability, issues with feasibility, and outreach (ie, ability to access the program and barriers to access including poor broadband network availability). The inclusion of residents of rural and regional areas enriches this evaluation as will quantitative data about participants’ exposure to the program.

The sample of 210 enables detection of a small effect size of f ² =.046 in the multiple regressions. Although the study uses all allocated participants in the outcome analyses, efforts are made to maximize retention by maximizing rapport at the baseline assessment and collecting multiple means to contact participants, including email, landline, and mobile phone contact details, and by assertive follow-up. With these strategies, the study is aimed to have at least 70% retention at 12 months.

Ethics approval to conduct this project was granted by the Uniting Care Health Human Research Ethics Committee (#Cassimatis9111) and the Queensland University of Technology Human Research Ethics Committee (#1100000783).