NCT05648903

The Transform Type 2 Diabetes Study

The Transform Diabetes Study: A Mixed-methods Exploratory Study to Evaluate the Acceptability and Potential Clinical Impact of a Choice of Dietary Interventions Delivered Through a Digital Group or 1-to-1 Care to Support Weight Loss and Improve Glycaemic Control in Adults With Type 2 Diabetes Within an Ethnically Diverse Population

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Oviva UK Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this mixed-methods, 12-month interventional study is to understand the effectiveness and acceptability of dietary interventions in type 2 diabetes mellitus (T2DM) in an ethnically diverse population. Three dietary interventions will be offered (total diet replacement, intermittent fasting and a low-carbohydrate diet) and two modes of remote care delivery will be used (group and one-to-one).

Detailed description

To date, there is little evidence focusing on preferences, motivating factors, and engagement in adults with type 2 diabetes when following dietary interventions to improve glycaemic control, nor on patient responses to remote group and one-to-one programs. In particular, this evidence is not available in populations with high levels of deprivation and that are culturally and ethnically diverse in which diabetes is most prevalent. The 120 participants will be recruited from GP practices in the Southwark area. Practices will be split into two comparable groups based on the demographic and clinical data of eligible patients. Participants from one group of practices will be offered a one-to-one lifestyle coaching program. Patients from the other group of practices will be offered a group lifestyle coaching program. The aim is to recruit 60 patients for each arm. All participants will be offered a choice of three dietary approaches: total diet replacement (TDR), intermittent fasting 5:2 approach and a low-carbohydrate diet. Interventions will be led by Diabetes Specialist Dietitians (DSD) and all participants will have access to supporting learning materials. All care will be delivered remotely. Participants will receive intensive support in the first 16 weeks and follow-up support for a further 36 weeks. Participants on the one-to-one pathway will access their support via the Oviva app, telephone or video calls. Participants allocated to the group intervention will access their support through video group sessions hosted by their DSD, and will be offered the opportunity to use a secure group chat for patients, between sessions. The evaluation will use a mixed methods approach, combining qualitative and quantitative analysis. Surveys, interviews, written material, and quantitative data will be used. This will allow for establishing learnings regarding patient choice, preference, experience, motivation, and engagement. Gaining insight into these perceptions can support our understanding as to how to best support engagement, understand the suitability of dietary interventions for different patients, and improve the quality and delivery of lifestyle interventions to support patients with type 2 diabetes in the future.

Conditions

• Type2diabetes

Interventions

Type	Name	Description
OTHER	Total diet replacement	The TDR intervention involves a low-calorie, nutritionally complete diet for 12 weeks consuming four meal replacement products exclusively per day, followed by a 4-week food-based reintroduction period; and then weight loss maintenance support monthly to 12 months. The TDR products will be provided to participants free of charge. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a TDR for an additional 4 weeks but participants would have to self-fund these products.
OTHER	Low-carbohydrate diet	Participants who choose this intervention will be supported to undertake a low-carbohydrate diet. During the first 12 weeks of the programme patients will be supported to consume below 100g carbohydrate per day, whilst being encouraged to increase protein, choose predominantly unsaturated fats alongside a high intake of non-starchy vegetables and low-carbohydrate fruits. After 12 weeks patients will be able to increase their carbohydrate intake up to 130g per day. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a 100g carbohydrate for an additional 4 weeks.
OTHER	Intermittent fasting 5:2	Participants will have the option to follow a 5:2 dietary approach whereby calories are significantly reduced on two days of the week to 500 calories per day for women and 600 calories per day for men. The placement of the "fasting" days can vary each week, but there must be two "fasting" days in each seven-day period. After 12 weeks, patients will have the option of continuing with the 5:2 approach for further weight loss or adopting a 6:1 approach whereby patients would only fast on 1 day in each seven-day cycle for weight maintenance. If a patient gains more than 2kg in the maintenance phase, they have the option to follow a 5:2 approach for an additional 4 weeks.

Timeline

• Start date: 2022-01-07
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2022-12-13
• Last updated: 2022-12-13

Locations

1 site across 1 country: United Kingdom