Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04916314 |
| Other study ID # |
15434 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
November 2022 |
| Source |
University of Oxford |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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, Second Nature. 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.
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.
1. 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).
The clinician will randomise the participant at the baseline appointment. This is an
individually randomised 1:1 to 2 arms: Intervention (12 week, app-based dietary support), or
control (usual care; no active additional intervention). The randomisation will be conducted
using the in-built randomisation software. This ensures full allocation concealment as
information on future allocations is not accessible to the person randomising. Due to the
nature of the intervention it will not be possible to blind members of the study team or
participants to allocation.
Participants randomised to the intervention group will receive an email giving 12 weeks of
access to the app/website. The intervention, provided by Second Nature, involves diet,
activity and behaviour change components. It comprises a three-month remote behavioural
change programme with mentoring from a registered dietitian or nutritionist (health coach),
peer group support, structured education articles and activity tracking technology. These
elements are accessed via a smartphone or web-based application. Each participant will also
receive a hard copy of an instructional handbook and a recipe book.
Participants randomised to the intervention group will consult their GP to adjust medication
as appropriate to avoid hypotension or hypoglycaemia following a guideline.
Participants randomised to the control group will receive no additional intervention, and
will continue to receive their usual NHS diabetes care from their general practice.
All Participants will be followed up after 3 months (visit 2) and at 12 months (visit 3). At
this appointment they will have the same procedures as at their baseline assessment repeated:
their weight and blood pressure will be recorded, and blood tests taken (3 sample tubes - for
HbA1c, lipid profile and liver function). Participants will be asked to complete the same
online questionnaires (PAID score, EQ5D, and 24 hour dietary recall) as they completed at
baseline, and serious adverse events and events of concern (serious hypoglycaemia) will be
recorded.
A purposively sampled proportion of participants from the intervention group (aiming to
achieve diversity of age, race, and success and engagement with the programme measured by
weight/HbA1c outcomes and engagement metrics respectively) will be contacted via telephone
for a semi-structured interview to discuss their experience of the intervention, after they
complete the 3 month intervention period. Interviews will last approximately 30 minutes. With
participants consent this will be audio-recorded.
The duration of the SAE recording period for each participant lasts from their enrolment on
to the study, to their completion of the study.
The study results will be reported in accordance with the CONSORT (Consolidated Standards of
Reporting Trials) 2010 statements. A full analysis plan will be prepared and finalised before
any data analysis.
The primary statistical analysis of efficacy outcomes will be carried out on the basis of
intention-to-treat (ITT). This is, after randomisation, participants will be analysed
according to their allocated intervention group irrespective of what intervention they
actually receive. The investigators will endeavour to obtain full follow-up data on every
participant to allow full ITT analysis, but the investigators will inevitably experience the
problem of missing data due to withdrawal, loss to follow up, or non-response to
questionnaire items.
The investigators will analyse the primary continuous outcome with a linear model adjusting
for baseline value of the relevant variable where relevant. For exploratory analyses, the
investigators will use analogous models, but interpret the data in an exploratory manner
rather than confirmatory. For binary outcomes (e.g. remission), the investigators will test
for a difference in proportions using logistic regression.
Based on previous studies of this intervention(5) and studies in similar populations(3), an
8-10mmol/mol change in HbA1c at 12 months in the intervention group in those who engage with
the programme (SD 8.6mmol/mol), with a 1-2mmol/mol (SD 6mmol/mol) change in the control group
is estimated. With α and β set at 0.05 this would require approximately 48 participants;
however to power for a co-primary outcome would require 72 to 88 participants in total
(allowing for variability in estimated effect size). In similar trials of behavioural
interventions an expected retention to follow up of >80%; allowing for the online nature of
this trial, and the retention rates of observational studies of this intervention the
investigators will aim to recruit 100 participants to allow for cumulative attrition at the
intervention sign-up, engagement, and follow up stages. The results from the trial will be
prepared as comparative summary statistics (difference in proportions or means) with 95%
confidence intervals. All the tests will be done at a 5% two-sided significance level.
