Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lindus Health | INDUSTRY |
Not provided
Not provided
Not provided
This is a multicentre, open-label Randomised Controlled Trial run in the United Kingdom. The main aims are to assess whether the Habitual Remission Programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.
Participants will be randomly allocated to the Habitual Programme or standard care as delivered by the National Health Service (NHS). They will take a home blood test for HbA1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. These measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention.
Participants will be recruited from General Practitioner (GP) surgeries in England, managed by Lindus Health. Research Nurses at Lindus Health will complete screening and informed consent procedures.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Intervention participants will be given an initial 12-week low energy-diet (LED) and will have continual use of an intensive behaviour education programme delivered through an app. |
|
| Standard of care arm | Other | All participants in the control arm will receive standard care provided by the National Health Service. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital therapeutic and intensive lifestyle programme | Combination Product | Initial 12-week LED and behaviour education app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss of ≥15kg | Number of participants that achieved ≥15kg | 6-months |
| HbA1C <6.5% (48mmol/mol) | Number of participants who have achieved HbA1C <6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication. | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic Control | Changes in HbA1C from baseline to mid and endpoints. | 3-months- 6-months |
| Weight control | Changes in weight from baseline to mid and endpoints. |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carol Le Roux, Professor | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lindus Health Ltd | London | London | SE1 3ER | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29221645 | Background | Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5. | |
| 30852132 |
| Label | URL |
|---|---|
| Habitual Health Ltd (Sponsor) | View source |
Not provided
Data will be entered into a validated Electronic Data Capture (EDC) platform. Direct access to the EDC platform will be granted to authorised representatives from the Sponsor, Lindus Health and the regulatory authorities to allow trial-related monitoring, audits and inspections.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
A multicentre, open-label, parallel design, randomised controlled trial.
Not provided
Not provided
Due to the nature of the lifestyle programme, participants, clinicians and data collectors will not be able to be masked, however allocation will be concealed from the statistician in charge of performing the analysis.
| Standard of care | Other | Standard of care. |
|
| 3-months- 6-months |
| Systolic blood pressure (SBP) | Changes in SBP from baseline to mid and endpoints. | 3-months- 6-months |
| Diastolic blood pressure (DBP) | Changes in DBP from baseline to mid and endpoints. | 3-months- 6-months |
| Medication use | Medication use reported by the participant. | Baseline, 3-months and 6-months |
| Weight loss ≥10kg | Number of participants that achieved ≥10kg | 6-months |
| Safety of Intervention | Monitoring the number of Adverse Events (AEs), Severe Adverse Events (SAEs) and (S)AE's that constitute Major Adverse Cardiovascular Events and Major Adverse Diabetes Events | Baseline- 6-months |
| HbA1C <6.5% (48mmol/mol) | Number of participants with an HbA1C <6.5% (48mmol/mol) after a 6-month follow up | 12-months (6-months after completing the trial). |
| Background |
| Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6. |
| D004700 | Endocrine System Diseases |