None listed
Conditions
Brief summary
The purpose of this research is to assess the effectiveness of a 16-week web-based low carbohydrate diet program for adults with type 2 diabetes, toward facilitating improvements in glycaemic control, assessed on primary outcome HbA1c. In addition, dietary intake data and self-efficacy will be assessed, along with changes in weight, anti-diabetes medication and diabetes-related comorbidities. Study recruitment will occur online across Australia, with the aim of recruiting 100 adults with non-insulin dependent type 2 diabetes aged between 40-89 years. Participants will be randomised to standard care plus web-based intervention or standard care only. Participants will be provided with login details to the intervention website to access weekly structured behaviour change modules and on demand resources that assist participants to practically implement a low carbohydrate diet. An assessment of participants' experience of and engagement with the intervention will also be explored after the intervention.
Interventions
Intervention participants will receive a 16 week automated web-based low carbohydrate dietary intervention, alongside their standard care. According to the Royal Australian College of General Practice (2016), standard care for patients with type 2 diabetes typically includes routine appointments with their physician to monitor glycaemic control, diabetes complications and other health parameters.
The web-based intervention consists of theoretically-grounded, weekly structured behaviour change
Intervention participants will receive a 16 week automated web-based low carbohydrate dietary intervention, alongside their standard care. According to the Royal Australian College of General Practice (2016), standard care for patients with type 2 diabetes typically includes routine appointments with their physician to monitor glycaemic control, diabetes complications and other health parameters. The web-based intervention consists of theoretically-grounded, weekly structured behaviour change modules that guide the participants to consume a low carbohydrate diet, encouraging participants to consume between 50-100 grams of carbohydrates per day, or otherwise defined as carbohydrate intake <26% total energy intake (Huntriss et al. 2018). Participants will be provided with login access to the intervention web-platform, which contains a range of on demand resources and delivers the weekly modules sequentially, on a weekly basis over the 16 weeks. Weekly modules encourage dietary behaviour change by providing education about and comparisons of different carbohydrate foods, information about type 2 diabetes, low carbohydrate eating guidelines, menu planning tips, food and beverage choices, recipes, food preparation tips, cooking demonstrations, eating out, menu examples, and other resources. Weekly modules consist of short videos, brief summaries and links to additional resources. During the 16-week intervention, twice weekly email notifications are sent to participants to notify them of new modules and to prompt usage of intervention content. With the weekly modules being sequentially delivered, alongside email reminders, it is estimated participants will login to the website once per week to engage with videos and other content. Following the intervention, a mixed-methods process evaluation will explore website usage and engagement, assessing quantitative data from user-experience questionnaires, detailed website statistics and email usage rates, in addition to capturing qualitative data. Semi-structured interviews will be conducted with a maximum of 20 intervention participants (n=8-20). Selection for qualitative interviews will be based on the first 20 participants who provided consent and are available to be interviewed post-intervention. Jedha Dening will conduct the interviews via phone with audio recording, by permission. Qualitative data analysis will be conducted independently by a third-party researcher using Nvivo software.
Sponsors
Dr Shariful Islam
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 40-89 years with non-insulin dependent type 2 diabetes. Participants will need to be based in Australia, have access to the internet, an active email address, able to read and understand English, and provide informed consent.
Exclusion criteria
Participants will be excluded if they have prediabetes, type 1 diabetes, or gestational diabetes, are pregnant or lactating, have or are at risk of disordered eating, have been diagnosed with cardiovascular or renal disease, have terminal disease or severe complications that may compromise their ability to participate (proliferative retinopathy, severe neuropathy, cancer, end stage renal disease/serious kidney disease), have had bariatric surgery, are vegan or vegetarian, are currently on or have taken a weight loss program in the past 3 months, are participating in other clinical studies
Outcome results
None listed