Open access Protocol

Manchester Intermittent Diet in

Gestational Diabetes Acceptability

BMJ Open: first published as 10.1136/bmjopen-2023-078264 on 10 February 2024. Downloaded from http://bmjopen.bmj.com/ on April 8, 2025 by guest .
Study (MIDDAS-­GDM): a two-­arm
randomised feasibility protocol trial of
an intermittent low-­energy diet (ILED)

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in women with gestational diabetes and
obesity in Greater Manchester
Elizabeth Dapre ‍ ‍,1,2 Basil G Issa,2,3 Michelle Harvie ‍ ‍,2,4,5 Ting-­Li Su,6
Brian McMillan ‍ ‍,7 Andrea Pilkington,2 Fahmy Hanna,8 Avni Vyas,2,9
Sarah Mackie,2 James Yates,2 Benjamin Evans,2 Womba Mubita,3
Cheryl Lombardelli2,5

To cite: Dapre E, Issa BG, ABSTRACT

Harvie M, et al. Manchester Introduction The prevalence of gestational diabetes
STRENGTHS AND LIMITATIONS OF THIS STUDY
Intermittent Diet in Gestational mellitus (GDM) is rising in the UK and is associated with ⇒ This mixed-­method feasibility study includes both
Diabetes Acceptability Study quantitative and qualitative evaluation of the ac-
maternal and neonatal complications. National Institute
(MIDDAS-­GDM): a two-­arm ceptability of the dietary intervention.
randomised feasibility protocol for Health and Care Excellence guidance advises first-­line
management with healthy eating and physical activity ⇒ This study has been informed by an experienced
trial of an intermittent low-­
energy diet (ILED) in women which is only moderately effective for achieving glycaemic patient and public involvement and engagement
with gestational diabetes targets. Approximately 30% of women require medication group.
and obesity in Greater with metformin and/or insulin. There is currently no ⇒ This study involves a small sample size and is not
Manchester. BMJ Open strong evidence base for any particular dietary regimen to powered to show efficacy of the intervention.
2024;14:e078264. doi:10.1136/ ⇒ Women joining this study are likely to be highly mo-
improve outcomes in GDM. Intermittent low-­energy diets
bmjopen-2023-078264
(ILEDs) are associated with improved glycaemic control tivated and adherence may not reflect that seen in
the wider general population.
► Prepublication history and reduced insulin resistance in type 2 diabetes and
and additional supplemental could be a viable option in the management of GDM. This
material for this paper are study aims to test the safety, feasibility and acceptability of
available online. To view these
an ILED intervention among women with GDM compared analysis of participant and healthcare professionals’
files, please visit the journal
online (https://doi.org/10.1136/​
with best National Health Service (NHS) care. experiences of the diet. Exploratory outcomes include the
bmjopen-2023-078264). Method and analysis We aim to recruit 48 women with number of women requiring metformin and/or insulin.
GDM diagnosed between 24 and 30 weeks gestation from Ethics and dissemination Ethical approval has been
Received 28 July 2023 antenatal clinics at Wythenshawe and St Mary’s hospitals, granted by the Cambridge East Research Ethics Committee
Accepted 11 January 2024 Manchester Foundation Trust, over 13 months starting (22/EE/0119). Findings will be disseminated via publication
in November 2022. Participants will be randomised (1:1) in peer-­reviewed journals, conference presentations and
to ILED (2 low-­energy diet days/week of 1000 kcal and shared with diabetes charitable bodies and organisations
5 days/week of the best NHS care healthy diet and physical in the UK, such as Diabetes UK and the Association of
activity advice) or best NHS care 7 days/week until British Clinical Diabetologists.
delivery of their baby. Primary outcomes include uptake Trial registration number NCT05344066.
© Author(s) (or their and retention of participants to the trial and adherence
employer(s)) 2024. Re-­use to both dietary interventions. Safety outcomes will
permitted under CC BY. include birth weight, gestational age at delivery, neonatal
INTRODUCTION
Published by BMJ. hypoglycaemic episodes requiring intervention, neonatal Background
For numbered affiliations see hyperbilirubinaemia, admission to special care baby unit In the UK up to 16% of pregnant women
end of article. or neonatal intensive care unit, stillbirths, the percentage develop gestational diabetes mellitus (GDM)
of women with hypoglycaemic episodes requiring third-­ and the incidence is rising, in part due to
Correspondence to
Dr Elizabeth Dapre; party assistance, and significant maternal ketonaemia increasing rates of obesity and maternal
​elizabeth.​dapre@​manchester.​ (defined as ≥1.0 mmol/L). Secondary outcomes will assess age.1 2 GDM is associated with maternal and
ac.u​ k the fidelity of delivery of the interventions, and qualitative neonatal complications (the risk increases

Dapre E, et al. BMJ Open 2024;14:e078264. doi:10.1136/bmjopen-2023-078264 1

Open access

with poor glycaemic control), including macrosomia, of participants in the ILED group completed the study
shoulder dystocia, caesarean sections, neonatal hypogly- and achieved a 6% reduction in their baseline body
caemia and/or hyperbilirubinaemia, preterm delivery, weight. 42% achieved an HbA1c of <48 mmol/mol.18

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pre-­eclampsia and stillbirth.2 Women who have had GDM Given the strong overlap between GDM and T2DM, an
have an estimated 7-­fold to 10-­fold risk of developing type ILED may be a promising dietary intervention for those
2 diabetes (T2DM) later in life, and their children have a with GDM.
higher risk of developing adult obesity and T2DM.2–4 A successful dietary approach to glycaemic control
Excessive weight gain in pregnancy is a particular could empower women to take charge of the manage-
problem for women with GDM.5 Harper et al demon- ment of their GDM. Women with GDM are motivated
strated that, in women with GDM, every additional 1 to modify their diet driven by a desire to improve foetal

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lb/week gained following diagnosis of GDM resulted in outcomes.19–21
a 36%–83% increased risk of pre-­eclampsia, caesarean Our patient and public involvement and engagement
section, macrosomia and large for gestational age babies.5 (PPIE) work indicates that women find the current NICE
Such studies highlight the importance of adequate healthy eating guidance6 7 confusing and vague. Our
weight control throughout pregnancy in women with PPIE work has indicated that women are keen to try alter-
GDM in order to reduce both maternal and neonatal native dietary approaches, particularly if alternative diets
complications. are more effective in preventing the need to progress to
First-­line therapy for GDM is diet and physical activity. medications such as metformin and insulin.
National Institute for Health and Care Excellence (NICE)
guidance encourages a healthy diet with increased fruit Aim
and vegetables, low-­glycaemic index (GI) foods, reduced The aim of this trial is to test the safety, feasibility and
refined sugars, regular mealtimes and regular physical acceptability of an ILED in GDM to inform a future large-­
activity.6 7 These dietary measures fail to achieve glycaemic scale randomised controlled trial (RCT).
targets in ~30% of women who require medication with
metformin and/or insulin.8 A range of dietary approaches
METHODS
have been studied including daily diets promoting low-­GI
Trial design
diets (limiting refined and promoting complex carbohy-
The study is a 28-­week feasibility two-­arm RCT in one
drates), continuous modest energy restriction (1800 kcal/
National Health Service (NHS) trust performed in
day) and low carbohydrate diets.9 There is currently no
patients with GDM and body mass index (BMI) ≥27.5 kg/
strong evidence base for any particular dietary regimen
m2, or ≥25 kg/m2 in high-­risk minority ethnic groups (ie,
to improve outcomes in GDM.
South Asian, Black African and African Caribbean) in
Greater Manchester between December 2022 and July
Intermittent low-energy diets (ILED)
2024.22 23 There will be an embedded qualitative substudy
The pathogenesis of GDM is strongly linked to obesity
for participants and healthcare professionals (HCPs). Due
and chronic insulin resistance with many clinicians
to the nature of the intervention, it will not be possible
viewing GDM as a form of evolving T2DM. ILEDs
to blind the participants, clinicians or study team to the
typically include several days of a food based or meal
treatment allocation after randomisation (the statistician
replacement (eg, drinks/bars) low-­energy diet (650–
and laboratory technicians will remain blinded).
1000 kcal), with a standard healthy (non-­ restrictive)
diet recommended on the remaining days of the week. Trial setting and recruitment
These diets are associated with significant reductions Participants will be recruited from antenatal clinics
in weight, insulin resistance and hyperglycaemia in at Wythenshawe and St Mary’s Hospitals, Manchester
patients with pre-­diabetes (Haemoglobin A1C (HbA1c) Foundation Trust (MFT) between November 2022 and
between 42 and 47 mmol/mol, impaired glucose December 2023. This is an urban area within Greater
tolerance, or impaired fasting glycaemia), those with Manchester, and MFT serves patients from a wide range
T2DM, and otherwise healthy subjects with overweight/ of minority ethnic and sociodemographic backgrounds.
obesity.10–17 These changes are equivalent to, or greater Women may self-­ refer to the antenatal clinic or be
than, those achieved with standard daily energy restric- referred by their primary care team. Assessments will be
tion. A popular intermittent diet involves 2 consecu- carried out at MFT, or remotely if required by COVID-­19
tive or non-­consecutive days/week of a low-­energy diet restrictions. The qualitative substudy will be carried out
(650–1000 kcal) and 5 days of normal eating/week, at MFT, remotely, or at a location of the participant’s
known as the 5:2 diet. The Manchester Intermittent choosing. We aim to recruit eligible participants over a
versus Daily Diabetes App Study (MIDDAS), a study period of 13 months. Potential participants will be given
comparing an ILED and a continuous low-­energy diet written information about the study and the opportunity
in T2D conducted in our unit, has shown the feasibility to ask questions about the study prior to providing written
and safety of an ILED (800 kcal for 2 days/week) in consent (online supplemental files 1 and 2).
patients with T2DM and obesity, including those using
insulin.18 At the end of the study, approximately 70%

2 Dapre E, et al. BMJ Open 2024;14:e078264. doi:10.1136/bmjopen-2023-078264

 Open access

Eligibility criteria in line with sample size recommendations for feasibility

Participant flow studies.27–29
Participants who fulfil the broad eligibility criteria will be This number will allow us to enable estimation of recruit-

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notified about the trial by the GDM nurse/midwife at the ment/retention parameters with sufficient precision. For
time of their diagnosis. Those who are interested will be example, based on 40 completed participants, it will enable
provided with a comprehensive patient information sheet recruitment rates in the region of 25% to be estimated with
(online supplemental file 1) and more detailed eligibility an error of ±13.42% at most; retention of 85% will be esti-
screening questions (figure 1). They will be asked to mated with error of ±11.07% at most. It is also sufficient for
attend their first appointment having fasted for at least estimation of variability (eg, SD) in gestational weight gain
6 hours and complete a 4-­day food diary (in line with our and capillary glucose concentrations (proposed outcomes

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department’s usual care). On attending their first routine for the future definitive trial) with negligible bias.30
clinic appointment, interested participants will receive
further information from the research team. They will Randomisation
have the opportunity to ask questions, have their eligibility The randomisation schedule will be independently set up
confirmed and will be asked for their written consent to and known only by the trial statistician. The trial statis-
take part. Baseline assessments will be taken and partic- tician will be blinded to the participant’s identity using
ipants will be randomised to their allocated treatment ‘sealed envelope’ software (https://www.sealedenvelope.​
group using an online randomisation platform. Partici- com/). Randomisation will be carried out by generating
pant flow through the study is demonstrated in figure 2. an online pseudorandom list with random permuted
blocks of varying size, known only to the statistician, and
Sample size will be stratified for two variables:
We plan to recruit 24 participants per study arm (n=48) ► Age (18–35, >35 years).
2 2
which, when considering an estimated attrition rate of ► BMI (27.5–34.99 kg/m and>35 kg/m ; >25–32.49 kg/
2 2
15%, will provide complete outcome data on 40 partici- m and >32.5 kg/m for high-­ risk minority ethnic
pants.24–26 It has been estimated that 24 participants per groups (ie, South Asian, Black African and African
group will be sufficient to determine study outcomes, Caribbean).

Figure 1 Inclusion and exclusion criteria. BMI, body mass index; GDM, gestational diabetes; NHS, National Health Service;
OGTT, oral glucose tolerance tests.

Dapre E, et al. BMJ Open 2024;14:e078264. doi:10.1136/bmjopen-2023-078264 3

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Dapre E, et al. BMJ Open 2024;14:e078264. doi:10.1136/bmjopen-2023-078264

Participant flow through trial. GDM, gestational diabetes; NHS, National Health Service
Open access

Figure 2

4
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These stratification variables have been chosen to protein foods, 3–4 portions of wholegrain carbohydrates,
reduce potential bias as we expect varying severity of 1×7 g portion of fat, 5 portions of vegetables, 2 of fruit and
GDM with increasing age and BMI and possible differ- 3 of dairy/dairy alternatives. Food and drink will be self-­

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ences in diet adherence.31 selected and not provided by the study team. Participants
Treatment to intervention and control groups will be will be provided with comprehensive food lists, advice on
allocated in a 1:1 ratio. A member of the research team portion sizes for the low-­energy days and suggested menus
who will be unaware of the randomisation algorithm (prin- and recipes to follow for both the low-­energy and NICE
cipal investigator, clinical research nurse, clinical research recommended healthy diet days (online supplemental
fellow or project manager) will trigger the randomisation file 4). Both diets can be successfully adapted for people
procedure onsite; participants and clinicians will then be of different ethnicities and those following omnivorous,

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informed of the allocated treatment group. Clinicians will vegetarian and vegan diets. Participants will be asked to
not be blinded due to the need to remain astute to safety, measure their capillary glucose four times each day and
adherence and side effects, requiring open and honest their ketones on (and the morning after) the two low-­
discussions with patients at each appointment. The stat- energy days (online supplemental file 3).
istician will remain blinded to treatment allocation until
all outcome measures for all subjects have been collected. Outcomes
Primary outcomes
Interventions ► Uptake rate measured as a percentage of eligible
Study arm 1: best NHS care diet
participants who consent to take part, including the
All dietetic advice will be face-­to-­face or via video calls
proportion of women who were screened who did
or the telephone. Participants will receive one-­ to-­
one
not meet the eligibility criteria, and the number of
personalised written and verbal advice from a dietitian
women who did not give consent to take part.
to follow NICE diet and physical activity recommenda-
► Recruitment rate measured as the number of eligible
tions.6 7 Dietitians and midwives will receive training to
participants who consent to take part per month.
ensure standardised delivery of information in clinic,
► Retention rate measured as the number of randomised
and standardised patient information leaflets will be
participants who complete the trial (those who attend
supplied to include information about increased fruit/
the final visit) and the percentage of participants who
vegetable intake, low-­GI foods and a reduction in free
attend all eight visits.
sugars. Information will include advice about the impor-
► Adherence to the dietary interventions assessed from
tance of regular meals; dietary advice aims to ensure that
self-­reported adherence to the potential low-­calorie
participants include at least 70 g protein/28 g fibre, and
predominantly monounsaturated and polyunsaturated days between randomisation and delivery.
► Completion of self-­assessed glucose and ketone read-
fats as per American Diabetes Association recommenda-
tions.32 Participants will be advised to be physically active, ings assessed as a percentage of the required readings.
► Safety outcomes:
for example, walking for 30 min after a meal. Participants
– Percentage of women following ILED/best NHS
will receive ongoing dietetic education and support every
2 weeks until delivery. This level of support is higher than care with hypoglycaemia (episodes of blood glucose
typically provided in NHS GDM antenatal clinics due to of <3.0 mmol/mol) and hypoglycaemia requiring
limited resources but has been used to reflect best NHS third-­party assistance as measured by participants.
care. They will receive suggested menus and recipes to – Percentage of women who develop significant ket-
follow the NICE recommended healthy diet for GDM. onaemia in both groups (defined as ≥1.0 mmol/L)
Participants will be asked to measure their capillary as measured by participants.
glucose four times each day and their ketones on two – Percentage of neonatal hypoglycaemic episodes
random (recorded) days of the week of their choosing requiring intervention (blood glucose checked
(online supplemental file 3). 2 hours post delivery and 2 hours thereafter for
12 hours according to local protocol), neonatal
Study arm 2: ILED birth weight, gestational age at delivery, hyperbili-
Participants will receive the same level of dietetic support rubinaemia/jaundice and/or admission to Special
as the best NHS care group. They will be given advice Care Baby Unit or neonatal intensive care, and
on adopting an ILED which involves 2 non-­consecutive stillbirths.
low-­energy diet days/week (1000 kcal to include 100 g – The incidence and rate of other adverse events (eg,
low-­GI carbohydrate and 70 g of protein) and 5 days/ headaches, lethargy, constipation or complications
week of the NICE healthy eating low-­GI diet and physical requiring hospital admission) between the start
activity recommended for the best NHS care group. The of the trial intervention and delivery recorded as
low-­energy days involve women selecting a set number mild, moderate and severe, as defined by Common
of portions of protein, carbohydrate, fat, fruit, vegeta- Terminology Criteria for Adverse Events (CTCAE
bles and dairy/dairy alternatives as described in previous V.5).34 Hospital admission for routine labour and
studies.33 Each low-­energy day includes ~210 g of lean delivery will not be classified as an adverse event.

Dapre E, et al. BMJ Open 2024;14:e078264. doi:10.1136/bmjopen-2023-078264 5

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Secondary outcomes activity will be measured using the IPAQ—Short Form,

► Completeness of collection of trial endpoints and diet quality will be assessed using the UK Diabetes
including the percentage of completed weight meas- and Diet Questionnaire.37 38 These questionnaires are

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urements, 4-­day food diaries and International Phys- self-­reported by participants and have been chosen as
ical Activity Questionnaire (IPAQ) scores. they are widely used and validated tools.
► Fidelity of delivery of the interventions will be meas-
ured through the number and modality of completed Food diaries
planned patient contacts, electronic and paper food 4-­
day dietary records will be completed using Libro
diaries, and self-­reported capillary glucose and ketone (Nutritics Mobile Application) or paper food diaries,
measurements. which will be entered into Nutritics software (Nutritics,

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► Qualitative analysis of the acceptability and implemen- Dublin, Ireland).39 Participants who wish to use Libro will
tation of the interventions will be explored among a receive one-­to-­one training to use this by the study dieti-
subset of participants (~10 in each group) and HCPs tian. Diaries will provide the research team with infor-
through in-­depth interviews. mation about the intake of energy, carbohydrate, fat,
protein, fibre, GI and the timing of meals for participants
Exploratory outcomes in both groups. Participants will be asked what other
The following outcomes will be explored without statis- dietary modifications, if any, they have made at their fort-
tical inference. nightly dietitian reviews to establish the adoption of any
► Maternal outcomes: alternative dietary practices in the cohort.
– The percentage of women requiring metformin
and/or insulin. Adverse events
– Four-­ point capillary glucose profiles during the Participants in both groups will be asked about any
third trimester (four times daily until delivery). adverse effects that they have experienced at each visit.
– Change in fasting blood test results between base- These will include, but are not limited to, the potential
line measurements, 36–37 weeks gestation, and 12 effects of a low-­energy diet, for example, headache, leth-
weeks post delivery (including oral glucose toler- argy, dizziness, constipation, indigestion, poor concen-
ance tests). tration and hunger. Adverse events will be graded as per
– Mode of delivery, development of preeclampsia, CTCAE V.5.34 Participants will be issued with a partici-
polyhydramnios (maximum liquor volume pool pation/emergency card with emergency contact details
depth ≥8 cm). for the research team to be carried at all times and to be
– Quality of life and health status questionnaires shown to the attending physician in case of emergency
(World Health Organisation Quality of Life (Brief admission to hospital. All participants will be issued with
Version) (WHOQoL-­ BREF) and 36-­ Item Short clear instructions as to how to manage a hypoglycaemic
Form Survey (SF-­36) questionnaires).35 36 and/or ketonaemic event (online supplemental file 5).
► Foetal outcomes:
Data management
– Foetal weight.
Participant data will be anonymised and will be stored in
– Gestational age at delivery.
line with the Medicines for Human Use (Clinical Trials)
Measurements Amended Regulations 2006 and the Data Protection Act
The full schedule of assessments can be found in figure 3. (2018) and archived in line with the Medicines for Human
Use (Clinical Trials) Amended Regulations (2006) as
Physical measurements defined in the MFT Clinical Trials Office Archiving SOP
Height, weight and blood pressure will be measured using (11; Retention of Data, Off-­Site Archiving, and Destroying
standardised calibrated equipment in antenatal clinic. Documents). Deidentified data will be stored in a study-­
specific Research Electronic Data Capture database. The
Blood samples sponsor will periodically audit the site study file, a sample
Fasting venous blood samples will be collected to of the case report form, consent forms and source data,
assess maternal HbA1c, fasting glucose, insulin, beta-­ and check accuracy of the study database to ensure satis-
hydroxybutyrate, liver function tests, free fatty acids, factory completion.
thyroid function tests and full blood count. At the end
of the study, all samples will be disposed of in accordance Statistical methods
with the Human Tissue Act (2004). A statistical analysis plan specifying the full details of the
primary and secondary outcomes, other variables and
Questionnaires methods will be produced prior to trial analysis. The
Participants will be asked to complete four questionnaires main analysis will be conducted via intention-­ to-­
treat
at four time points throughout the trial (self-­reported). population and will not undertake any significance tests.
Quality of life and health status will be assessed using the Descriptive, graphical (summary) and basic statistics (eg,
WHO Quality of Life Questionnaire (brief version) and (1) number, frequencies and percentages, (2) mean and
the 36-­Item Short Form Survey, respectively.35 36 Physical SD, or (3) median and quartiles as appropriate) will be

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7
Open access

Dapre E, et al. BMJ Open 2024;14:e078264. doi:10.1136/bmjopen-2023-078264

Schedule of assessments.
Figure 3
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Table 1 Trial progression criterion

Feasible with modification of

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Feasible (green) the protocol (amber) Not feasible (red)
Recruitment ≥4 patients/month >2 patients/month ≤2 patients/month
Uptake to the ≥15% 10%–15% <10%
feasibility study
Retention to the >70% 50%–70% <50%
feasibility study
Adherence to the ILED >50% of the low-­energy days 30%–50% of the low-­energy <30% of the low-­energy days

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intervention completed (2 /week between days completed (2 /week completed (2 /week between weeks
weeks 24-­30 and delivery) between weeks 24-­30 and 24-­30 and delivery)
delivery)
ILED, intermittent low-­energy diets.

presented as appropriate for each group, respectively, MFT using Braun and Clarke’s thematic analysis approach
for group difference jointly, and for each stratum. Per-­ to identify key issues around the acceptability, usefulness
protocol analysis will be considered as a secondary anal- of the programmes, and feasibility of a subsequent trial.40
ysis. Levels of missing data will be investigated and used Analysis will be inductive: open-­ended, exploratory and
to inform future studies. No imputation will be used. The driven by the data.
end of study questionnaire will be analysed using appro- All participants will also be asked to complete an
priate descriptive statistics for closed questions and key optional and anonymous end of study questionnaire
themes will be extracted without formal analysis from developed by the study team at their postpartum visit
open questions to inform future research. (online supplemental file 6). This will give participants
the opportunity to feedback on their experience and will
Progression criterion enable the study team to identify improvements to the
The success of the feasibility trial will be defined by the design of a possible follow-­up study.
progression criteria as outlined in table 1. Any concerns
regarding a low retention rate will be discussed with the Trial steering committee (TSC)
PPIE group. Interviews will include those who withdraw The TSC will include an independent consultant endo-
from the study to address potential reasons for withdrawal crinologist, obstetrician, dietitian and the patient repre-
with the aim to improve retention in future. sentative. The committee will oversee the trial to ensure
that it is carried out to the expected standards. The TSC
Qualitative substudy will liaise with the CI to develop a schedule of meetings,
Participants will be invited to take part in an optional proposed to occur every 4 months, with meetings to occur
qualitative substudy at 11–13 weeks post partum. HCPs no less than annually. Minutes will be taken at TSC meet-
delivering the interventions will also be invited to take ings and copies of the minutes will be filed in the Trial
part in this study. Master File; they will be shared with relevant stakeholders
We will undertake semistructured interviews with a as appropriate.
subset of women from each group (ILED n=10 and best
NHS Care n=10) at around 12 weeks post delivery. The Patient and public involvement
final sample size will be contingent on obtaining data satu- Patient and public involvement was actively sought
ration. We will also interview a sample of HCPs involved throughout the planning and design of this trial and
in the delivery of care to study participants, including continues to form a key part of the trial as it progresses.
dieticians, obstetricians and midwives, including those The PPIE group assisted in the development of all partic-
with leadership and clinical managerial roles. Sampling ipant materials and provided valuable insight into the
will be purposive, aiming to obtain women from a range wording of participant information and acceptability
of ethnic groups, ages, socioeconomic backgrounds and of the proposed intervention. The PPIE group will be
self-­reported engagement with the intervention. Partic- updated as the trial progresses and a further focus group
ipants and HCPs will be asked about their experiences will be held to advise on the interview schedule and
and thoughts regarding the intervention, including moti- wording for the qualitative substudy. The group will also
vating factors, and facilitators/barriers to engagement. be invited to aid in the development of summarising key
Interviews will be conducted by a researcher from the findings for dissemination to relevant patient groups.
University of Manchester/MFT who is independent of the
research staff involved in the delivery and assessment of
the programmes. Analysis will be conducted by two inde-
pendent researchers at the University of Manchester/

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ETHICS AND DISSEMINATION Patient and public involvement Patients and/or the public were involved in the
This study has been approved by the Cambridge East design, or conduct, or reporting, or dissemination plans of this research. Refer to
the Methods section for further details.
Research Ethics Committee and is sponsored by MFT.

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Patient consent for publication Not applicable.
Findings will be disseminated via publication in peer-­
reviewed journals, conference presentations and shared Provenance and peer review Not commissioned; externally peer reviewed.
with diabetes charitable bodies and organisations in the Supplemental material This content has been supplied by the author(s). It has
not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been
UK, such as Diabetes UK and the Association of British
peer-­reviewed. Any opinions or recommendations discussed are solely those
Clinical Diabetologists. Anonymised data will be avail- of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and
able on formal request once the principal results of responsibility arising from any reliance placed on the content. Where the content
the study have been published. Planned modifications includes any translated material, BMJ does not warrant the accuracy and reliability

Protected by copyright, including for uses related to text and data mining, AI training, and similar technologies.
of the translations (including but not limited to local regulations, clinical guidelines,
to the protocol will be approved by the research ethics terminology, drug names and drug dosages), and is not responsible for any error
committee before they are adopted into the study. An and/or omissions arising from translation and adaptation or otherwise.
audit trail of ethical amendments and documentation Open access This is an open access article distributed in accordance with the
will allow monitoring by the research team and external Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits
regulatory bodies. others to copy, redistribute, remix, transform and build upon this work for any
purpose, provided the original work is properly cited, a link to the licence is given,
This is the first study to assess the feasibility and safety of and indication of whether changes were made. See: https://creativecommons.org/​
an ILED in GDM as compared with best NHS care. Given licenses/by/4.0/.
the increasing incidence of GDM and associated health
ORCID iDs
risks, this research is both pertinent and important. The
Elizabeth Dapre http://orcid.org/0000-0001-8220-4514
study is not powered to show differences between ILED Michelle Harvie http://orcid.org/0000-0001-9761-3089
and best NHS care; however, the planned quantitative Brian McMillan http://orcid.org/0000-0002-0683-3877
and qualitative assessments will inform the feasibility of
the programme and a future definitive trial.

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