An interventional study of Total diet replacement and Low-carbohydrate diet in Type2diabetes, sponsored by Oviva UK Ltd. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Oviva UK Ltd · Not applicable, Interventional, and Treatment
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).
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
All participants are offered a choice of three dietary approaches.
Other: Total diet replacement · Other: Low-carbohydrate diet · Other: Intermittent fasting 5:2
All participants are offered a choice of three dietary approaches.
Other: Total diet replacement · Other: Low-carbohydrate diet · Other: Intermittent fasting 5:2
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.
Also known as: TDR
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.
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.
Also known as: 5:2
Intervention primary outcome- Change in Hba1c (mmol/l)
Evaluating improvement in Hba1c (mmol/l) upon dietary intervention
Time frame: at 6, 12 & 24 months
Intervention secondary outcome- weight
Change in weight (kg) and BMI (kg/m2)
Time frame: at 6, 12 & 24 months
Intervention secondary outcomes- lipids
Change in lipid markers (mmol/l) total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Time frame: 12 & 24 months
Intervention secondary outcomes- blood pressure
Change in blood pressure (systolic and diastolic) by British and Irish Hypertension Society validated monitors
Time frame: 12 & 24 months
Intervention secondary outcomes- NHS resource use including medication cost
The project will explore changes in primary and secondary care resource use and medication use at 12 and 24 months, and associated costs, by treatment arm for participating patients relative to the five years before enrolment. The net financial impact of the intervention will be analysed by combining the estimated costs of the intervention with the estimated changes in routine resource use before and after the intervention.
Time frame: 12 & 24 months
Intervention secondary outcomes- change in quality of life
Patient reported outcome measures (PROMs) including change in quality of life (EQ5D) and ability to self-manage diabetes
Time frame: baseline & 12 months
Intervention secondary outcomes- diabetes remission
Diabetes remission defined as 2 HbA1c readings \< 48mmol/mol without diabetes medications at least 6 months apart
Time frame: 12 & 24 months
Other study outcomes- Patient questionnaires on acceptability, motivations and preferences
The project aims to explore the acceptability of three different dietary regimes and the choices patients make. It will explore differences between the 1 to 1 and group delivery approaches in terms of enrolment, retention, patient experience and patient outcomes. The online surveys shared with participants throughout the study will cover overall impressions of the intervention, which aspects of the service were most helpful, responses to the diets challenges experienced and whether and how these were overcome, and the effect on knowledge of diabetes and the ability to manage the condition.
Time frame: 4 & 12 months
Other study outcomes- engagement with the programme
Gaining insight into patient engagement and motivation in relation to the programme can support our understanding as to how to best support engagement and improve the quality and delivery of lifestyle interventions to support patients with type 2 diabetes in the future. Patient engagement will be assessed through attendance, app usage and patient outcomes.
Time frame: 12 months
Plan to share: No
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