Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-01-07
2024-07-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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One-to-one
All participants are offered a choice of three dietary approaches.
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.
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.
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.
Group
All participants are offered a choice of three dietary approaches.
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to give consent for participation including collection of clinical outcomes
* Diagnosis of type 2 diabetes
* Minimum age of 18 years
* Maximum age of 70 years
* Minimum BMI of 27kg/m² (adjusted to 25kg/m² in people of South Asian or Chinese origin)
* Upper weight limit of 180kg (due to upper weight limit of BodyTrace scales)
* HbA1c eligibility:
* If on diabetes medication, HbA1c ≥ 43 mmol/mol
* If on diet alone, HbA1c ≥ 48 mmol/mol
* HbA1c \<108mml/mol
* Ability to speak, read and receive care in English
* Access to internet and email address
Exclusion Criteria
* Pregnant or planning to be pregnant in the next 6 months
* Current breastfeeding
* Significant physical comorbidities:
* Active cancer, receiving treatment
* Myocardial infarction or stroke in last 6 months
* Severe heart failure defined as equivalent to the New York heart Association grade 3 or 4 (NYHA)
* eGFR \<30 mls/min/1.73m2
* Active liver disease (except non-alcoholic fatty liver disease (NAFLD),Severe angina, cardiac arrhythmia including atrial fibrillation or prolonged QT syndrome
* Active substance use disorder
* Active eating disorder
* Porphyria
* On current weight management programme / had or awaiting bariatric surgery (unless willing to come off waiting list)
* Health professional assessment that the person is unable to understand or meet the demands of the programme and/or monitoring requirements
* Taking monoamine-oxidase inhibitor medication
* Taking warfarin
* Taking varenicline (smoking cessation medication)
* Have attended for monitoring and diabetes review when this was last offered, including retinal screening, and commit to continue attending reviews, even if remission is achieved
* Active/investigation for gastric or duodenal ulcers
18 Years
70 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Oviva UK Ltd
OTHER
Responsible Party
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Principal Investigators
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Lucy Jones
Role: PRINCIPAL_INVESTIGATOR
Locations
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Oviva UK ltd
London, , United Kingdom
Countries
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Other Identifiers
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IRAS ID: 295915
Identifier Type: REGISTRY
Identifier Source: secondary_id
Transform study
Identifier Type: -
Identifier Source: org_study_id