Type2diabetesTransformNCT05648903
The Transform Type 2 Diabetes Study
A study testing Total diet replacement, Low-carbohydrate diet and Intermittent fasting 5:2 in people with Type2diabetes, run by Oviva UK Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- Total diet replacement, Low-carbohydrate diet and Intermittent fasting 5:2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2022to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered with one of the Nexus Group GP Practices
- 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)
Show all 13Show fewer
- 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
Who cannot join
- Currently taking insulin
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the 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
- Being tested
- Total diet replacement, Low-carbohydrate diet, Intermittent fasting 5:2
- Keywords
- Type 2 Diabetes, dietary intervention, digital, diverse population, low carbohydrate, low energy, intermittent fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total diet replacementOther
Also called TDR
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 dietOther
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 5:2Other
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| One-to-one | Experimental | All participants are offered a choice of three dietary approaches. Receives: Other: Total diet replacement; Other: Low-carbohydrate diet; Other: Intermittent fasting 5:2 |
| Group | Experimental | All participants are offered a choice of three dietary approaches. Receives: Other: Total diet replacement; Other: Low-carbohydrate diet; Other: Intermittent fasting 5:2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention primary outcome- Change in Hba1c (mmol/l)
Evaluating improvement in Hba1c (mmol/l) upon dietary intervention
Measured: at 6, 12 & 24 months
Secondary outcomes (6)
Intervention secondary outcome- weight
Change in weight (kg) and BMI (kg/m2)
Measured: at 6, 12 & 24 months
Intervention secondary outcomes- lipids
Change in lipid markers (mmol/l) total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)
Measured: 12 & 24 months
Intervention secondary outcomes- blood pressure
Change in blood pressure (systolic and diastolic) by British and Irish Hypertension Society validated monitors
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 & 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start7 Jan 2022
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two modes of remote care delivery are used (one-to one and group).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oviva UK Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lucy Jones, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648903
- Sponsor's protocol ID
- Transform study
- Other IDs
- IRAS ID: 295915
- Acronym
- Transform
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05648903
- Acronym / sponsor ID
- Transform / Transform study
- Conditions
- Type2diabetes
- Keywords
- Type 2 Diabetes, dietary intervention, digital, diverse population, low carbohydrate, low energy, intermittent fasting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oviva UK LtdUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two modes of remote care delivery are used (one-to one and group).
| Arm | Type | Receives |
|---|---|---|
| One-to-one | Experimental | Other: Total diet replacement, Other: Low-carbohydrate diet, Other: Intermittent fasting 5:2All participants are offered a choice of three dietary approaches. |
| Group | Experimental | Other: Total diet replacement, Other: Low-carbohydrate diet, Other: Intermittent fasting 5:2All participants are offered a choice of three dietary approaches. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Registered with one of the Nexus Group GP Practices
- 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
Key exclusion criteria (19 listed)
- Currently taking insulin
- Pregnant or planning to be pregnant in the next 6 months
- Current breastfeeding
- Significant physical comorbidities:
- Active cancer, receiving treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total diet replacementAlso: TDRThe 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 | Group, One-to-one |
| Low-carbohydrate dietParticipants 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 | Group, One-to-one |
| Intermittent fasting 5:2Also: 5:2Participants 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 | Group, One-to-one |
Primary outcome
Intervention primary outcome- Change in Hba1c (mmol/l)
Time frame: at 6, 12 & 24 months
Evaluating improvement in Hba1c (mmol/l) upon dietary intervention
6 secondary outcomes
Intervention secondary outcome- weight
Time frame: at 6, 12 & 24 months
Intervention secondary outcomes- lipids
Time frame: 12 & 24 months
Intervention secondary outcomes- blood pressure
Time frame: 12 & 24 months
Intervention secondary outcomes- NHS resource use including medication cost
Time frame: 12 & 24 months
Intervention secondary outcomes- change in quality of life
Time frame: baseline & 12 months
Intervention secondary outcomes- diabetes remission
Time frame: 12 & 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucy Jones principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total diet replacement, Low-carbohydrate diet and Intermittent fasting 5:2 in people with Type2diabetes, run by Oviva UK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention primary outcome- Change in Hba1c (mmol/l) (time frame: at 6, 12 & 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.