Web-based low carbohydrate dietary intervention for adults with type 2 diabetes

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: 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 CONDITION: Metabolic and Endocrine ‐ Diabetes Type 2 diabetes; ; Type 2 diabetes PRIMARY OUTCOME: The primary outcome is mean difference of change in haemoglobin A1c (HbA1c) from baseline at week 16 between intervention and control, assessed using the MyHealthTest diabetes HbA1c test service.[Baseline and week 16 ] SECONDARY OUTCOME: Anti‐diabetes medication and dosages, assessed by participant self‐report, study‐specific online questionnaire with free text entry 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. ; [Baseline and week 16] Assess body mass index using participant self‐reported weight and height measurements, submitted via study‐specific online questionnaire with free text entry[Weight and height baseline, weight only week 16 ] Diabetes‐related comorbidities, assessed by participant self‐report, study‐specific online questionnaire with checkbox selection[Baseline and week 16] Dietary intake (food, beverages and supplements), assessed with 24‐hour food recall (24HR) using the web‐based automated self‐administered ASA24‐Australia assessment tool.[Baseline and week 16] Participants experience of the intervention (intervention group only), assessed by self‐report using the User Engagement Scale short form/Honeycomb Model questionnaire, entered via Qualtrics online form[Week 16] Participants experience of the intervention (intervention group only), assessed via qualitative semi‐structured individual interviews in a purposive sample of intervention participants[Week 16] Self‐efficacy, assessed by self‐report using the Diabetes Management Self‐Efficacy Scale questionnaire, entered via Qualtrics online form[Baseline and week 16] Website utilisation patterns and engagement (intervention group only), assessed by website analytics and email usage rates for frequency, intensity and duration metrics for each week of the 16‐week intervention[Weeks 1‐16]
Epistemonikos ID: 17f2523207641aec01b89a61b118b88a497dd0bd
First added on: Aug 24, 2024