Gestational DiabetesMIDDAS-GDMNCT05344066
Manchester Intermittent Diet in Gestational Diabetes Acceptability Study
A study testing Best NHS Care and Intermittent Low Energy Diet in people with Gestational Diabetes and Gestational Diabetes Mellitus in Pregnancy, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS) care in women with gestational diabetes and obesity in Greater Manchester. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Intermittent Fasting
- What is being tested?
- Best NHS Care and Intermittent Low Energy Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2022to 31 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women ≥18 years
- BMI of ≥27.5kg/m2 or a BMI ≥25 kg/m2 in high risk minority ethnic group (i.e. South Asian, Black African, African Caribbean) and <50 kg/m2 at booking appointment (8-12 weeks' gestation)
- Newly diagnosed GDM according to local diagnostic criteria (fasting glucose ≥5.3mmol/l and/or 2-hour postprandial glucose ≥8.5mmol/l in a 75g OGTT) scheduled to receive first line diet and physical activity (best NHS care)
- 24-30 weeks pregnant at screening appointment
Who cannot join
- Pregestational type 1 or type 2 diabetes.
- Fasting glucose of ≥7 or 2-hour postprandial of ≥11 on OGTT (immediate intervention with medication would be required in this group of women)
- Current multiple pregnancy
- Maturity Onset Diabetes of the Young (MODY)
- Significant comorbid disease that in PI's opinion would preclude participation in the study e.g. chronic kidney disease, significant cardiac disease, history of disordered eating or severe psychological problems.
- Current participation in a GDM medication treatment trial
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- People who are not capable of providing informed consent or adhering to the monitoring and safety protocols
- People who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy, and/or those prescribed weight loss medications (e.g. orlistat).
- Medications at the time of the OGTT that may interfere with results (e.g. high dose oral steroids, immunosuppressants)
- Previous history of intrauterine growth restriction
- Women who have lost more than 5% of their weight from booking appointment to screening appointment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation trust
Manchester, M13 9WU
About this study
Official title: MIDDAS-GDM: A Two-Arm Randomised Feasibility Protocol Trial of an Intermittent Low-Energy Diet (ILED) in Women With Gestational Diabetes and Obesity in Greater Manchester
A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS) care in women with gestational diabetes and obesity in Greater Manchester.
Read the detailed description
Overall aim:
The aim of this trial is to test the safety, feasibility, and acceptability of an ILED in GDM to inform a future large-scale RCT.
Background:
Up to 16% of pregnant women in the United Kingdom develop GDM with rising rates due to increasing rates of obesity and maternal age. GDM affects both maternal and neonatal outcomes and is a high burden to patients and the NHS through frequent clinic visits, monitoring, and costly medications such as insulin. The National Institute for Health and Care Excellence (NICE) guidelines advocate healthy diet (with increased physical activity [PA]) as first-line therapy for GDM with approximately 30% progressing to metformin and/or insulin treatment. Our Patient and Public Involvement and Engagement work demonstrates that women with GDM are keen for alternative dietary interventions to reduce their need for medications. It has been shown that intermittent low energy diets improve glycaemic control in type-2 diabetes. The investigators wish to test the utility of ILED in GDM.
Primary Aim: to test the safety, feasibility, and acceptability of an ILED in GDM to inform a future large-scale RCT.
Primary Objectives:
- Uptake rate
- Recruitment rate
- Retention rate
- Adherence to the dietary interventions
- Completion of self-assessed glucose and ketone readings
Safety outcomes:
- Percentage of women following ILED/best NHS care with hypoglycaemia (episodes of blood glucose of <3.0mmol/mol)
- Percentage of women who develop significant ketonaemia in both groups (defined as ≥1.0mmol/L)
- Percentage of neonatal hypoglycaemic episodes requiring intervention, neonatal birth weight, gestational age at delivery, hyperbilirubinaemia/jaundice, and/or admission to Special Care Baby Unit or neonatal intensive care, and stillbirths
- The incidence and rate of other adverse events (e.g. headaches, lethargy, constipation, or complications requiring hospital admission) between the start of the trial intervention and delivery.
Secondary outcomes
- Completeness of collection of trial endpoints
- Fidelity of delivery of the interventions
- Qualitative analysis of the acceptability and implementation of the interventions
Exploratory outcomes The following outcomes will be explored without statistical inference.
- Maternal outcomes:
- The percentage of women requiring metformin and/or insulin
- Four-point capillary glucose profiles during third trimester
- Change in fasting blood test results between baseline measurements, 36-37 weeks' gestation, and 12 weeks post-delivery
- Mode of delivery, development of preeclampsia, polyhydramnios (maximum liquor volume pool depth ≥8 cm)
- Quality of life and health status questionnaires (WHOQoL-BREF and SF-36 questionnaires)
- Foetal outcomes:
- Foetal weight
- Gestational age at delivery
Method:
We aim to recruit 48 women with GDM diagnosed between 24-30 weeks gestation from antenatal clinics at Wythenshawe and St Mary's hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial, and adherence to both dietary interventions. Safety outcomes will include birthweight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0mmol/L) Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals' experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.
Qualitative evaluation:
Investigators will undertake qualitative analysis of the experiences and thoughts of approximately 5 participants per group and healthcare professionals delivering the interventions.
Anticipated impact and dissemination:
This study will inform the feasibility and design of a definitive RCT of ILED versus best NHS care in GDM. Findings will be disseminated to health professionals and patients through published articles, conference presentations and patient networks in collaboration with the patient and public involvement and engagement panel.
- Conditions
- Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Intermittent Fasting, Pregnancy Related, Diabetes, Diabetes in Pregnancy
- Being tested
- Best NHS Care, Intermittent Low Energy Diet
- Medical subject headings
- Diabetes, Gestational, Intermittent Fasting, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best NHS CareOther
Personalised advice and support from a diabetes dietician to follow NICE healthy eating diet and physical activity recommendations for GDM.
Intermittent Low Energy DietOther
Two non-consecutive days of a food based 1000 kcal diet and five days of the NICE healthy eating diet and physical activity recommendations for the best NHS care group.
| Study group | Role | What they receive |
|---|---|---|
| Best NHS Care | Active comparator | Best National Health Service (NHS) Care Receives: Other: Best NHS Care |
| Intermittent Low Energy Diet | Experimental | Intermittent Low Energy Diet Receives: Other: Intermittent Low Energy Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial recruitment rate
Uptake to trial will be measured as a percentage of eligible participants who consent to participate in the trial per month.
Measured: Duration of trial (68 weeks)
Retention to the trial
Retention rate will be measured as the percentage of participants who complete all scheduled 8 visits.
Measured: Duration of trial (68 weeks)
Trial uptake
Trial uptake will be measured as the percentage of eligible participants who consent to participate in the trial.
Measured: Duration of trial (68 weeks)
Adherence to the interventional intermittent low-calorie diet over course of study
Self-reported adherence to the two potential low-calorie days per week expressed as a percentage of the potential low-calorie days in the intermittent low energy diet group.
Measured: From randomisation (at 24-30 weeks' gestation) to delivery.
Adherence to capillary glucose and ketone measurements over course of study
The number of self-assessed glucose (4 times a day) and ketone (3 times a day on two days of the week) measurements in both groups over the course of the study.
Measured: From randomisation (at 24-30 weeks' gestation) to delivery
Episodes of hypoglycaemia requiring intervention
The percentage of women with self-reported hypoglycaemia (capillary blood glucose of <3.0 mmol/l) will be measured and compared between groups.
Measured: From 24-30 weeks' gestation until delivery.
Episodes of ketonaemia requiring intervention
The percentage of women with self-reported significant ketonaemia (capillary ketones >1 mmol/l) will be measured and compared between groups.
Measured: From 24-30 weeks' gestation until delivery.
Rates of neonatal hyperbilirubinaemia/jaundice
Percentage of neonatal hyperbilirubinaemia/jaundice (defined as a total serum bilirubin level above 86 μmol/l) episodes will be recorded in both groups.
Measured: From delivery until final visit at 12-13 weeks' postpartum
Rates of neonatal hypoglycaemia
Percentage of neonatal hypoglycaemic episodes requiring intervention (blood glucose checked 2-hours post delivery and 2-hours thereafter for 12 hours) will be recorded in both groups.
Measured: From delivery until 12 hours post-delivery
Neonatal birthweight
Neonatal birth weight will be measured in kilograms and recorded in both groups.
Measured: At delivery
Neonatal gestational age at delivery
Gestational age at delivery will be measured in weeks and recorded in both groups.
Measured: At delivery
Gestational age at delivery
Gestational age at delivery in weeks will be recorded in both groups.
Measured: At delivery
Rates of admission to special care baby unit or neonatal intensive care
Rates of admission to Special Care Baby Unit or Neonatal Intensive Care will be recorded in both groups.
Measured: From delivery until final visit at 12-13 weeks' postpartum
Number of stillbirths
Number of stillbirths will be recorded in both groups.
Measured: At delivery
Secondary outcomes (4)
Number of completed scheduled patient contacts
Completion of scheduled patient contacts with the trial dietitian and gestational diabetes midwife will be recorded and compared between groups.
Measured: Duration of trial (68 weeks)
Completion rates of food diaries
Participants will be asked to complete 4-day food diaries for 4 weeks of the trial at 24-28 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum. They will also be given the option of recording diaries during the other weeks as this may help with their adherence. Completion rates of the food diaries each week across the whole intervention as a percentage of weeks in both groups will inform the utility of food diaries for tracking diet behaviour in both groups
Measured: 4 day food diaries at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum.
Completion rates of International Physical Activity Questionnaire (IPAQ)
Participants will be asked to complete the IPAQ during 4 weeks of the trial at 24-28 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum. Completion rates will be measured as a percentage of weeks completed in both groups.
Measured: IPAQ questionnaire at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum.
The acceptability of the dietary interventions will be explored qualitatively
A subset of participants in both groups (approximately 5 participants from each group) will be invited to an optional qualitative substudy which will involve one semi-structured interview at the end of the intervention. Participants will be asked about their experiences and thoughts regarding the intervention. Key themes will be identified using Braun and Clarke's thematic analysis to identify key issues around the acceptability of the test intervention.
Measured: 12-13 weeks' postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start24 Nov 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised two-arm feasibility trial
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- National Institute for Health Research, United Kingdom, University of Manchester
- Responsible party
- Sponsor
- Investigators
- Basil Issa, Principal investigator, Manchester Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344066
- Sponsor's protocol ID
- B01410
- Acronym
- MIDDAS-GDM
- Status last verified
- Dec 2023
- First submitted
- 11 Feb 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient identifiable data will not be shared. Anonymised trial data will be available on reasonable request to the investigators.
Publications
Dapre E, Barrett E, McMillan B, Pilkington A, Hanna F, Vyas A, Lombardelli C, Mubita W, Athirampuzha J, Dosanjh L, Harvie M, Issa BG. Testing the feasibility of an intermittent low-energy diet in women with gestational diabetes. Diabet Med. 2026 Jul;43(7):e70258. doi: 10.1111/dme.70258. Epub 2026 Mar 20.
PubMed 41859862Dapre E, Issa BG, Harvie M, Su TL, McMillan B, Pilkington A, Hanna F, Vyas A, Mackie S, Yates J, Evans B, Mubita W, Lombardelli C. Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM): a two-arm randomised feasibility protocol trial of an intermittent low-energy diet (ILED) in women with gestational diabetes and obesity in Greater Manchester. BMJ Open. 2024 Feb 10;14(2):e078264. doi: 10.1136/bmjopen-2023-078264.
PubMed 38341207
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIDDAS-GDM: A Two-Arm Randomised Feasibility Protocol Trial of an Intermittent Low-Energy Diet (ILED) in Women With Gestational Diabetes and Obesity in Greater Manchester
- ClinicalTrials.gov ID
- NCT05344066
- Acronym / sponsor ID
- MIDDAS-GDM / B01410
- Conditions
- Gestational Diabetes, Gestational Diabetes Mellitus in Pregnancy, Intermittent Fasting, Pregnancy Related, Diabetes, Diabetes in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- National Institute for Health Research, United Kingdom, University of Manchester
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 25 Apr 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.
A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS) care in women with gestational diabetes and obesity in Greater Manchester.
Detailed description
Overall aim:
The aim of this trial is to test the safety, feasibility, and acceptability of an ILED in GDM to inform a future large-scale RCT.
Background:
Up to 16% of pregnant women in the United Kingdom develop GDM with rising rates due to increasing rates of obesity and maternal age. GDM affects both maternal and neonatal outcomes and is a high burden to patients and the NHS through frequent clinic visits, monitoring, and costly medications such as insulin. The National Institute for Health and Care Excellence (NICE) guidelines advocate healthy diet (with increased physical activity [PA]) as first-line therapy for GDM with approximately 30% progressing to metformin and/or insulin treatment. Our Patient and Public Involvement and Engagement work demonstrates that women with GDM are keen for alternative dietary interventions to reduce their need for medications. It has been shown that intermittent low energy diets improve glycaemic control in type-2 diabetes. The investigators wish to test the utility of ILED in GDM.
Primary Aim: to test the safety, feasibility, and acceptability of an ILED in GDM to inform a future large-scale RCT.
Primary Objectives:
- Uptake rate
- Recruitment rate
- Retention rate
- Adherence to the dietary interventions
- Completion of self-assessed glucose and ketone readings
Safety outcomes:
- Percentage of women following ILED/best NHS care with hypoglycaemia (episodes of blood glucose of <3.0mmol/mol)
- Percentage of women who develop significant ketonaemia in both groups (defined as ≥1.0mmol/L)
- Percentage of neonatal hypoglycaemic episodes requiring intervention, neonatal birth weight, gestational age at delivery, hyperbilirubinaemia/jaundice, and/or admission to Special Care Baby Unit or neonatal intensive care, and stillbirths
- The incidence and rate of other adverse events (e.g. headaches, lethargy, constipation, or complications requiring hospital admission) between the start of the trial intervention and delivery.
Secondary outcomes
- Completeness of collection of trial endpoints
- Fidelity of delivery of the interventions
- Qualitative analysis of the acceptability and implementation of the interventions
Exploratory outcomes The following outcomes will be explored without statistical inference.
- Maternal outcomes:
- The percentage of women requiring metformin and/or insulin
- Four-point capillary glucose profiles during third trimester
- Change in fasting blood test results between baseline measurements, 36-37 weeks' gestation, and 12 weeks post-delivery
- Mode of delivery, development of preeclampsia, polyhydramnios (maximum liquor volume pool depth ≥8 cm)
- Quality of life and health status questionnaires (WHOQoL-BREF and SF-36 questionnaires)
- Foetal outcomes:
- Foetal weight
- Gestational age at delivery
Method:
We aim to recruit 48 women with GDM diagnosed between 24-30 weeks gestation from antenatal clinics at Wythenshawe and St Mary's hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial, and adherence to both dietary interventions. Safety outcomes will include birthweight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0mmol/L) Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals' experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.
Qualitative evaluation:
Investigators will undertake qualitative analysis of the experiences and thoughts of approximately 5 participants per group and healthcare professionals delivering the interventions.
Anticipated impact and dissemination:
This study will inform the feasibility and design of a definitive RCT of ILED versus best NHS care in GDM. Findings will be disseminated to health professionals and patients through published articles, conference presentations and patient networks in collaboration with the patient and public involvement and engagement panel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised two-arm feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Best NHS Care | Active comparator | Other: Best NHS CareBest National Health Service (NHS) Care |
| Intermittent Low Energy Diet | Experimental | Other: Intermittent Low Energy DietIntermittent Low Energy Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women ≥18 years
- BMI of ≥27.5kg/m2 or a BMI ≥25 kg/m2 in high risk minority ethnic group (i.e. South Asian, Black African, African Caribbean) and <50 kg/m2 at booking appointment (8-12 weeks' gestation)
- Newly diagnosed GDM according to local diagnostic criteria (fasting glucose ≥5.3mmol/l and/or 2-hour postprandial glucose ≥8.5mmol/l in a 75g OGTT) scheduled to receive first line diet and physical activity (best NHS care)
- 24-30 weeks pregnant at screening appointment
Key exclusion criteria (11 listed)
- Pregestational type 1 or type 2 diabetes.
- Fasting glucose of ≥7 or 2-hour postprandial of ≥11 on OGTT (immediate intervention with medication would be required in this group of women)
- Current multiple pregnancy
- Maturity Onset Diabetes of the Young (MODY)
- Significant comorbid disease that in PI's opinion would preclude participation in the study e.g. chronic kidney disease, significant cardiac disease, history of disordered eating or severe psychological problems.
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 |
|---|---|---|
| Best NHS CarePersonalised advice and support from a diabetes dietician to follow NICE healthy eating diet and physical activity recommendations for GDM. | Other | Best NHS Care |
| Intermittent Low Energy DietTwo non-consecutive days of a food based 1000 kcal diet and five days of the NICE healthy eating diet and physical activity recommendations for the best NHS care group. | Other | Intermittent Low Energy Diet |
Primary outcome
Trial recruitment rate
Time frame: Duration of trial (68 weeks)
Uptake to trial will be measured as a percentage of eligible participants who consent to participate in the trial per month.
Retention to the trial
Time frame: Duration of trial (68 weeks)
Retention rate will be measured as the percentage of participants who complete all scheduled 8 visits.
Trial uptake
Time frame: Duration of trial (68 weeks)
Trial uptake will be measured as the percentage of eligible participants who consent to participate in the trial.
Adherence to the interventional intermittent low-calorie diet over course of study
Time frame: From randomisation (at 24-30 weeks' gestation) to delivery.
Self-reported adherence to the two potential low-calorie days per week expressed as a percentage of the potential low-calorie days in the intermittent low energy diet group.
Adherence to capillary glucose and ketone measurements over course of study
Time frame: From randomisation (at 24-30 weeks' gestation) to delivery
The number of self-assessed glucose (4 times a day) and ketone (3 times a day on two days of the week) measurements in both groups over the course of the study.
Episodes of hypoglycaemia requiring intervention
Time frame: From 24-30 weeks' gestation until delivery.
The percentage of women with self-reported hypoglycaemia (capillary blood glucose of <3.0 mmol/l) will be measured and compared between groups.
Episodes of ketonaemia requiring intervention
Time frame: From 24-30 weeks' gestation until delivery.
The percentage of women with self-reported significant ketonaemia (capillary ketones >1 mmol/l) will be measured and compared between groups.
Rates of neonatal hyperbilirubinaemia/jaundice
Time frame: From delivery until final visit at 12-13 weeks' postpartum
Percentage of neonatal hyperbilirubinaemia/jaundice (defined as a total serum bilirubin level above 86 μmol/l) episodes will be recorded in both groups.
Rates of neonatal hypoglycaemia
Time frame: From delivery until 12 hours post-delivery
Percentage of neonatal hypoglycaemic episodes requiring intervention (blood glucose checked 2-hours post delivery and 2-hours thereafter for 12 hours) will be recorded in both groups.
Neonatal birthweight
Time frame: At delivery
Neonatal birth weight will be measured in kilograms and recorded in both groups.
Neonatal gestational age at delivery
Time frame: At delivery
Gestational age at delivery will be measured in weeks and recorded in both groups.
Gestational age at delivery
Time frame: At delivery
Gestational age at delivery in weeks will be recorded in both groups.
Rates of admission to special care baby unit or neonatal intensive care
Time frame: From delivery until final visit at 12-13 weeks' postpartum
Rates of admission to Special Care Baby Unit or Neonatal Intensive Care will be recorded in both groups.
Number of stillbirths
Time frame: At delivery
Number of stillbirths will be recorded in both groups.
4 secondary outcomes
Number of completed scheduled patient contacts
Time frame: Duration of trial (68 weeks)
Completion rates of food diaries
Time frame: 4 day food diaries at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum.
Completion rates of International Physical Activity Questionnaire (IPAQ)
Time frame: IPAQ questionnaire at 24-30 weeks' gestation, 34-35 weeks' gestation, 36-37 weeks' gestation, and 12-13 weeks postpartum.
The acceptability of the dietary interventions will be explored qualitatively
Time frame: 12-13 weeks' postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41859862Dapre E, Barrett E, McMillan B, Pilkington A, Hanna F, Vyas A, Lombardelli C, Mubita W, Athirampuzha J, Dosanjh L, Harvie M, Issa BG. Testing the feasibility of an intermittent low-energy diet in women with gestational diabetes. Diabet Med. 2026 Jul;43(7):e70258. doi: 10.1111/dme.70258. Epub 2026 Mar 20.
- Derived from this study: PubMed 38341207Dapre E, Issa BG, Harvie M, Su TL, McMillan B, Pilkington A, Hanna F, Vyas A, Mackie S, Yates J, Evans B, Mubita W, Lombardelli C. Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM): a two-arm randomised feasibility protocol trial of an intermittent low-energy diet (ILED) in women with gestational diabetes and obesity in Greater Manchester. BMJ Open. 2024 Feb 10;14(2):e078264. doi: 10.1136/bmjopen-2023-078264.
- Individual participant dataSharing planned: Yes. Patient identifiable data will not be shared. Anonymised trial data will be available on reasonable request to the investigators.
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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.
Basil Issa principal investigator
Manchester Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best NHS Care and Intermittent Low Energy Diet in people with Gestational Diabetes and Gestational Diabetes Mellitus in Pregnancy, run by Manchester University NHS Foundation Trust 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 4 inclusion and 11 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 3 May 2024. 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?
Trial recruitment rate (time frame: Duration of trial (68 weeks)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05344066, which also lists 2 linked publications.
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 3 May 2024.