Testing the Effectiveness of a Low Carbohydrate Diet With Remote Support for Patients With Type 2 Diabetes in Primary Care, on Weight and Glycaemic Control: a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oxford
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Participants' HbA1c
Study Overview
Brief Summary
Excess adiposity is a key causal factor in developing type 2 diabetes and weight loss improves glycaemia and can put diabetes in to remission. There is evidence that low carbohydrate diets also reduce glycaemia. The aim of this trial is to test a behavioural support programme delivered remotely to reduce energy intake and carbohydrate intake in particular to improve glycaemic control in people recently diagnosed with type 2 diabetes. We will recruit participants from general practice diabetes registers who were diagnosed within the past six years and who want to and are able to follow an app-based behavioural support programme to change their diet and have a BMI of at least 27kg/m2 (≥30kg/m2 if of white European ethnicity). They will be individually randomised 1:1 using simple randomisation to either intervention or a no-intervention control. Blinding of participants or their clinicians is impossible. The intervention comprises a 12-week behavioural support programme delivered by app or web, which provides group-based peer support, recipes for food providing low energy meals that are low in carbohydrate. The programme is delivered by a commercial company who run NHS commissioned programmes in several areas of the UK. Clinicians will adjust medication for hypertension and diabetes as needed. The co-primary outcomes are change in participants' HbA1c from baseline to 3 months and baseline to 1 year, with p-value adjustment to reflect multiple testing. The secondary outcomes are remission from diabetes, weight change, change in cardiovascular risk factors, and change in quality of life at 3 months and 1 year. The trial will assess whether this app-based programme improves outcomes for people with type 2 diabetes relative to usual care.
Detailed Description
This is an individually randomised controlled trial. Participants, recruited via GP practices, will be randomised 1:1 with simple randomisation and no stratification to either the intervention group or control (usual care). They will be enrolled in the study for 1 year, of which the intervention (dietary support via the app) will run for 3 months. Most study procedures will be conducted online or remotely (by telephone) including: screening, eligibility assessment, informed consent, randomisation, engagement with the app-based intervention. Participants will be asked to attend 3 face to face appointments for the research study at their local GP practice for measurements to be taken (weight, blood pressure) and blood tests, at baseline, 3 months and 1 year, and will have 1 additional telephone contact with their GP or practice nurse before starting the intervention. Face to face appointments will be incorporated with routine clinical appointments when possible.
The investigators aim to recruit 100 participants via their GP practices. Based on a conservative response rate of 10% from similar previous studies, the investigators will approach approximately 1000 eligible individuals from approximately 10 GP practices in England. The primary care provider will search their electronic registers for eligible individuals and GPs will screen out those to whom it would be inappropriate to send a letter inviting them to enrol and referring them to a website to give informed consent.
Once consent has been given, participants will click on a link to the electronic data capture system database which will be activated following their consent, to complete the baseline assessment. All participants will complete a 2 part baseline assessment, firstly online and then at their GP practice.
- Online:
Participants will be asked to complete a baseline questionnaire requesting demographic information and their current medication, and the standard questionnaires that will be used in the study (the Problem Areas in Diabetes (PAID) score, the EQ5D (quality of life assessment), and a 24 hour dietary recall questionnaire ("Intake24 dietary assessment tool", where participants are asked to record all food and drink intake in the last 24 hours). This will also further assess whether people are sufficiently able to complete online trial procedures, and only those who complete the questionnaire will be randomised. Participants will be informed in the Participant Information Sheet that they will only be able to enter the study after completing the questionnaire fully in one attempt as the system will not allow them to go back into the questionnaire to answer the remaining questions later. This should take less than 30 minutes to complete. 2. At the GP practice (visit 1) Having completed the online assessment, participants will be asked (via message on their screen on completing the assessment, and followed up via email) to book the in-person portions of their baseline assessment at their GP practice for measures which cannot be conducted online. At this appointment, their height, weight and blood pressure will be measured and recorded, and a blood sample taken for baseline values (HbA1c, lipid profile, liver function tests).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The nature of the intervention means it is not possible to mask providers or patients
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 40 years or above.
- •Diagnosed with current type 2 diabetes (i.e. not in remission) in the last 6 years
- •BMI of ≥27kg/m2 (≥30kg/m2 if ethnicity recorded as white)
- •Has a smartphone or computer with internet access (and the correct operating system requirements to use the intervention programme)
- •Are able to complete the eligibility and baseline assessments online
- •Would like to make changes to their diet or lifestyle to improve their diabetes control, lose weight, or improve their general health
Exclusion Criteria
- •Unable to understand the study materials and interventions
- •Currently following a weight loss programme (defined as a structured, prescribed and monitored programme and not a self-directed weight loss attempt)
- •Pregnant, breastfeeding, or planning to become pregnant during the course of the study
- •History of bariatric surgery, including gastric banding
- •Currently using insulin therapy
- •Proliferative diabetic retinopathy, or maculopathy.
- •Recent myocardial infarction or stroke (<3 months)
- •Renal failure (chronic kidney disease stage 4 or 5)
- •Current active treatment for cancer (other than skin cancer treated with curative intent by local treatment only)
- •Their doctor does not feel they are appropriate to participate for another reason (e.g. active eating disorder diagnosis, significant psychological disturbance)
Outcomes
Primary Outcomes
Change From Baseline in Participants' HbA1c
Time Frame: Baseline to 12 months
Change in participants' HbA1c from baseline to 12 months
Change From Baseline in Participants' HbA1c
Time Frame: Baseline to 3 months
Change in participants' HbA1c from baseline to 3 months
Secondary Outcomes
- Diabetes Remission at 12 Months(1 year)
- Weight Change From Baseline(3 months,1 year)
- Change in Systolic Blood Pressure, From Baseline(3 months, 1 year)
- Change in Diastolic Blood Pressure, From Baseline(3 months, 1 year)
- Change in LDL Cholesterol From Baseline(3 months, 1 year)
- Change in Total Cholesterol:HDL Ratio From Baseline(3 months, 1 year)
- Change in HDL Cholesterol, From Baseline(3 months, 1 year)
- Change in Triglycerides, From Baseline(3 months, 1 year)
- Change in ALT From Baseline(3 months, 1 year)
- Change in Diabetes Related Quality of Life and Distresses - Problem Areas In Diabetes (PAID) Score From Baseline(3 months, 1 year)
- Change in Participants' EQ5D Score From Baseline(3 months, 1 year)