ClinicalTrials.gg
Sign In
RecruitingNCT06572345LEGENDUpdated Jul 9, 2026

Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study

An interventional study of Low-energy diet and Qualitive interview - LED participants in Pediatric Obesity and Type 2 Diabetes, sponsored by Nottingham University Hospitals NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Nottingham University Hospitals NHS Trust · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Not applicable
Ages
12 Years to 17 Years
Sex
All
01

Study summary

This is a multicentre, single-arm, feasibility study in adolescents with T2DM and obesity to investigate the recruitment and retention rates to a study using Low Energy Diets(LED). It will also provide estimates of weight loss needed to bring about remission to inform a larger randomised study. In addition a subgroup of participants and their parents/carers undertaking a period of LED will be interviewed to understand the participants experience of taking part. Two further groups will also be interviewed: participants and their parents/carers who have declined to take part in the LED to understand their motivations and barriers and healthcare practitioners who have participated in conducting the trial to understand their experience of the study.

Read the detailed description

LED intervention

The three-stage intervention, will be delivered by the local study dietitian and doctor. Participants will typically undergo a 12-week intensive LED intervention followed by a 12-week Food Re-introduction (FR) phase and then a Weight Maintenance (WM) phase. The aim is for participants to lose 15kg (or 15% of starting body weight if\<80kg at baseline) and achieve remission defined as an HbA1C \<48 mmol/mol three months apart.

The LED phase consists of a total meal replacement (TMR) diet for 12 weeks which contains 800-1000cal/day (with LED diets typically containing 800-1200kcal/day), and has been previously shown to be safe in young people. Available products include shakes, soups and bars from providers such as Cambridge 1:1, Lighter Life and Optifast. TMR products will be supplied and distributed by the study team at no cost to the participant. The experience of other investigators suggests that having prepared shakes and bars reduces the anxiety associated with meal choices and preparation. If participants are not able to adhere to only four meal replacement products a day, a low-energy meal option for up to one meal a day (instead of a TMR product and using low-calorie recipes provided as part of the study) may be suggested and discussed by the research team.

Following the initial LED phase, participants will enter the FR phase, typically over the next 12 weeks. This consists of a gradual reintroduction of food one meal at a time, in a structured stepwise progression and under the supervision of a dietitian. A recipe book of 400-500 kcal recipes has been developed for this purpose.

If the target weight is achieved before 12 weeks, the FR phase may be brought forward.

If the HbA1C has fallen to below the pre-diabetes range (less than 42 mmol/mol) on point of care testing, but the target weight has not been achieved, FR phase may still be initiated at 12 weeks. If the target weight is not achieved by 12 weeks and the HbA1C remains 48 mmol/mol or above, the LED phase could be extended to a maximum of a total of 20 weeks duration, in discussion with the participant and the parents/carers, as appropriate.

If, during FR, the participant gains 2kg or more, there is flexibility to regress a step along the FR pathway, at the discretion of the local team and in discussion with the participant and their family, mirroring the successful pragmatic approach of the DiRECT study. For instance, a participant who has introduced their first meal and gains 2kg, may go back to full LED; someone who has gained weight after moving from two to three meals a day may go back to two meals. A participant who gains 2kg or more in the WM phase, may similarly go back one step to two meals a day. Locally, our experience using the LED showed the importance of a flexible approach, with some young people finding benefit from a short break (e.g. for a family celebration) or a preference to start during school holidays.

Current standard practice is to measure weight at each clinic with height and HbA1C checked once every 3 months. In addition to these routine measurements, data on participants' weight, height, HbA1C and adherence will be collected by the local diabetes team at each face-to-face visit and entered directly into the study data collection forms by either a study healthcare professional (HCP) or research nurse, as well as recorded in the participants medical record.

During the LED and FR phases, participants will have two-weekly clinical contact with face-to-face contact at least every four weeks which will include repeat anthropometry (including weight and blood pressure). Biochemistry will be repeated.

During the maintenance phase, contacts will aim to be every four weeks with no more than six weeks between contacts.

Participants' data will be collected by the local diabetes team or research nurses at each visit and recorded in the participants medical record. Data will be entered into the study approved electronic case-report form (CRF) system by the local diabetes or research teams.

Study questionnaires will be undertaken at baseline, during LED, during FR and in the follow-up period using an approved electronic CRF system by either the participant or research nurse. Physical activity assessment, MRI scans and dual x-ray anthropometry (DXA) scans will be undertaken at baseline, during the transition between phases and at the end of the study period. Physical activity level will be assessed by using activity trackers, six-minute walking test and a physical activity questionnaire. MRI scans will measure internal adipose deposits and DXA will measure fat and lean mass, bone mineral density and bone mineral content. Blood samples will be taken and analysed in local laboratories of units participating in the study. Results of tests undertaken locally will be entered on participants' CRF by the local research team.

Additional Interviews

Semi-structured interviews will be undertaken by a chartered clinical psychologist with a subset of the young people who took part in the LED intervention to understand the adolescents experience of taking part in the study midway through the study and at the end.

Semi-structured interviews will also be undertaken by a chartered clinical psychologist with 10 young people and/or their family who opted not to take part in the LED study to help understand barriers to participation and how these can be minimised.

Qualitative interviews will also be conducted with at least 10 healthcare professionals from different sites involved in the study to garner feedback and experience as well as the HCPs impression of the experience of the study for the participants and their families.

It is suggested that the proposed number of interview participants will be sufficient to meet the research aims. However, data saturation (whereby no new information is reported) will guide the recruitment process. In each case, purposefully constructed interview guides will be formulated to enhance the rigour of the data generated. All interviews will be conducted remotely with Hilton Health Consultancy via an approved platform. All interviews will be recorded and transcribed and analysed by Hilton Health Consultancy.

This feedback will be instrumental in informing and shaping any subsequent randomised control trial.

02

Conditions studied

  • Pediatric Obesity
  • Type 2 Diabetes

Keywords

  • Type 2 diabetes mellitus
  • Paediatric
  • Obesity
  • Low-energy diet
  • Adolescent
  • Remission
03

In context

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's planned enrollment of 73 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

Nottingham University Hospitals NHS Trust is the lead sponsor of 107 studies on the registry; 19 are open to participants now.

Browse Nottingham University Hospitals NHS Trust studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

LED intervention

  • Diagnosis of T2DM (defined as an ≥48mmol/mol, in the absence of features of type 1 or monogenic/syndromic diabetes).
  • Current HbA1C ≥48 (or ≥42 on antidiabetic medication) and ≤ 80 mmol/mol. To allow for the day-to-day variation in HbA1C and differences between point of care laboratory tests, -2 or +2 mmol/mol in the HbA1C result will be allowed in the current criteria if one of them is between or equal to 42-80mmol/mol.
  • Aged 12 to 17 years old.
  • ≥981st centile (+2 SD) for age and sex (UK90 growth reference data).

  • :

    • Received from the young person (age 16-17) OR
    • Received from young person's parent/carer, with patient assent (age 12-15).
  • Willing to engage in and commit to low energy diet, FR and weight management phases including follow-up and attending study visits.

LED Intervention Interviews

The same interview inclusion criteria for LED intervention, with the following additional requirements:

Patients:

  • Informed consent:

    • Received from the young person (age 16-17) OR
    • Received from young person's parent/carer, with patient assent (age 12-15).
  • Willing to take part in a qualitative interview alongside a parent/carer.

Relative/Carer:

  • A relative/carer for a young person meeting the above LED participant eligibility criteria.
  • Informed consent from the relative/carer to participate in the interview.
  • Willing to take part in a qualitative interview alongside the young person.

Non-LED Qualitative Interview only participants

  • Diagnosis of T2DM (defined as an HbA1C ≥48mmol/mol, in the absence of features of type 1 or monogenic/syndromic diabetes).
  • Current HbA1C ≥48 (or ≥42 on antidiabetic medication) and ≤80 mmol/mol.
  • Aged 12 to 17 years old.
  • BMI ≥91st centile (+2 SD) for age and sex (UK90 growth reference data).

  • Informed consent:

    • Received from the young person (age 16-17) OR
    • Received from young person's parent/carer, with patient assent (age 12-15).
  • Willing to take part in a qualitative interview alongside a parent/carer only.

HCPs

  • Registered HCP.
  • Experience of delivering this trial to the adolescents.
  • Willing to take part in a qualitative interview about undertaking motivational interviewing training and conducting/delivering the LED intervention study.

Exclusion criteria

Exclusion criteria

LED intervention

  • greater than 82mmol/mol (to allow for the variation in HbA1c differences).
  • Presence of diabetes-related autoantibodies, as per local centre guidelines.
  • Confirmed mono-genetic cause of obesity (e.g. SIM1 mutation) or diabetes-associated syndrome such as Prader-Willi syndrome, Bardet-Biedl or Wolfram's syndrome.
  • Secondary diabetes (post bone marrow transplant/chemotherapy).
  • Significant psychiatric co-morbidity.
  • Breastfeeding, pregnant or planning to conceive during the LED and FR phases (female participants will be advised on need for effective methods during the 12-month study period, section 5.1.1.10).
  • Any other condition which, in the opinion of the study investigator, would make it inappropriate to undertake a period of LED. (All reasons for not approaching patients will be recorded and analysed anonymously. Cases can be discussed with the core study group if there is doubt).
  • Participation in another interventional trial within 6 months.
  • and/or assent not received.
  • Pre-existing retinopathy.
  • Dietary avoidance (including, but not limited to, due to allergies, intolerances, religious reasons and lifestyle choices) to any ingredients in the meal replacement products, including lactose.
  • Previous scoliosis repair.

Non-LED Qualitative Interview only participants

  • HbA1C greater than 80mmol/mol.
  • Presence of diabetes-related autoantibodies, as per local centre guidelines.
  • Confirmed mono-genetic cause of obesity (e.g. SIM1 mutation) or diabetes-associated syndrome such as Prader-Willi syndrome, Bardet-Biedl or Wolfram's syndrome.
  • Secondary diabetes (post bone marrow transplant/chemotherapy).
  • Significant psychiatric co-morbidity.
  • Breastfeeding, pregnant or planning to conceive during the LED and FR phases (female participants will be advised on need for effective contraceptive methods during the 12-month study period, section 5.1.1.10).
  • Any other condition which, in the opinion of the study investigator, would either make it inappropriate to undertake a period of LED. (All reasons for not approaching patients will be recorded and analysed anonymously. Cases can be discussed with the core study group if there is doubt).
  • Participation in another interventional trial within 6 months.
  • Informed consent and/or assent not received.
  • Pre-existing retinopathy.
  • Dietary avoidance (including, but not limited to, due to allergies, intolerances, religious reasons and lifestyle choices) to any ingredients in the meal replacement products, including lactose.
  • Previous scoliosis repair.

HCPs

  • None.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
73 participants (estimated)

Study arms

  • Experimental
    Low Energy Diet (LED)

    33 participants will undergo a 12 week low energy diet (LED), followed by a 12 week food reintroduction phase and 24 week weight maintenance phase. 10 participant across all sites from this intervention will be asked to complete a qualitative interview at 2 time points throughout the study, alongside their parent/carer, to understand their thoughts around the intervention, their experience taking part in the study and suggestions for improvement. Additionally, further interviews will be undertaken with participants and their relatives/carers who declined to take part in the LED portion of the study to understand the reasons why/barriers to them taking part in the intervention. Furthermore, 10 health care professionals (HCPs) from different sites involved in the study will be invited to take part in interviews to garner feedback and experience as well as their impression of the experience of the study for the participants and their families.

    Dietary Supplement: Low-energy diet · Other: Qualitive interview - LED participants · Other: Qualitive interview - Participants declining LED · Other: Qualitive interview - Health Care Professionals (HCPs)

Interventions

  • Dietary supplementLow-energy diet

    For the first 12 weeks during the LED, participants will have 4 meal replacement products each day. The following 12 weeks consists of a gradual reintroduction of food one meal at a time, in a structured stepwise progression, under the supervision of a dietitian. They will then undergo 28 weeks of weight maintenance to see if they are able to keep their weight stable.

  • OtherQualitive interview - LED participants

    Semi-structured interviews with 10 of the LED participants and their relative/carer.

  • OtherQualitive interview - Participants declining LED

    Semi-structured interviews with 10 participants who declined the LED, and their relative/carer.

  • OtherQualitive interview - Health Care Professionals (HCPs)

    Semi-structured interviews with 10 HCPs involved in delivery of the trial.

06

What researchers measure

Primary outcomes

  1. Proportion of potential participants that can be recruited to an LED intervention

    Number of eligible participants identified compared to those consented, passed screening and started on LED intervention.

    Time frame: 12 months

  2. Retention rate measured by by data availability for participant height.

    Height obtained for the participant at: 1. End of LED phase (12 weeks) 2. End of FR phase (24 weeks) 3. End of maintenance phase (12 months)

    Time frame: 12 months

  3. Retention rate measured by by data availability for participant weight.

    Weight obtained for the participant at: 1. End of LED phase (12 weeks) 2. End of FR phase (24 weeks) 3. End of maintenance phase (12 months)

    Time frame: 12 months

  4. Retention rate measured by by data availability for participant HbA1C.

    HbA1C obtained for the participant at: 1. End of LED phase (12 weeks) 2. End of FR phase (24 weeks) 3. End of maintenance phase (12 months)

    Time frame: 12 months

Secondary outcomes

  1. Proportion of participants that adhere to the LED

    Defined by at least 5% weight loss at end of LED phase compared to baseline.

    Time frame: 12 weeks

  2. Degree of weight loss achieved in those who adhere to the LED and if this is maintained at 12-months.

    Weight as measured at end of LED phase (12 weeks), compared against weight as measured at baseline. Weight as measured at end of FR phase (24 weeks), compared against weight as measured at baseline. Weight as measured at end of maintenance (12 months) compared against weight at baseline. Weight as measured at end of FR compared against weight at the end of LED phase. Weight as measured at end of maintenance (12 months) compared against weight at the end of LED phase.

    Time frame: 12 months

  3. Do those who adhere to the LED achieve remission? To determine the standard deviation of the proportion of participants that achieve remission (to estimate the sample size for a definitive randomised trial).

    Percentage weight loss in those who achieve remission of T2DM defined as an HbA1C \<48 mmol/mol on two occasions at least 3 months apart, in the absence of anti-diabetes medication. This will help to determine the standard deviation of the proportion of participants that achieve remission, to enable an estimation of sample size for a future, definitive, randomised control trial.

    Time frame: 12 months

  4. Do those who adhere to the LED achieve remission? To determine the standard deviation of the proportion of participants that achieve remission (to estimate the sample size for a definitive randomised trial).

    Absolute weight loss in those who achieve remission of T2DM defined as an HbA1C \<48 mmol/mol on two occasions at least 3 months apart, in the absence of anti-diabetes medication. This will help to determine the standard deviation of the proportion of participants that achieve remission, to enable an estimation of sample size for a future, definitive, randomised control trial.

    Time frame: 12 months

  5. Adverse effects

    Collection of adverse events at every study visit.

    Time frame: 12 months

  6. Is the study, including the intervention, investigations and assessments, deliverable consistently across different sites using the standardised study resources.

    Qualitative interviews with patients and carers (patient and carers interviewed together) who participate in the LED, and those who do not.

    Time frame: 12 months

  7. Is the study, including the intervention, investigations and assessments, deliverable consistently across different sites using the standardised study resources.

    Qualitative interviews with healthcare professionals who are involved in delivering the study.

    Time frame: 12 months

  8. Which biomarkers and pathways are upregulated and which are downregulated in young people with T2DM and what is the response to an LED intervention.

    Understanding the pattern of and metabolic changes in: • water soluble metabolites before (at baseline) and after following a LED (at end of LED - 12 weeks, end of FR -24 weeks and end of WM - 12 months).

    Time frame: 12 months

  9. Which biomarkers and pathways are upregulated and which are downregulated in young people with T2DM and what is the response to an LED intervention.

    Understanding the pattern of and metabolic changes in: • lipid metabolites before (at baseline) and after following a LED (at end of LED - 12 weeks, end of FR -24 weeks and end of WM - 12 months).

    Time frame: 12 months

  10. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Changes in clinical markers, such as blood pressure, including both systolic and diastolic measurements (mmHg).

    Time frame: 12 months

  11. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    HbA1C

    Time frame: 12 months

  12. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Full Blood Count

    Time frame: 12 months

  13. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Ferritin

    Time frame: 12 months

  14. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    White Blood Cell Count

    Time frame: 12 months

  15. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Platelet count

    Time frame: 12 months

  16. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Urea and electrolytes

    Time frame: 12 months

  17. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    alanine transaminase (ALT)

    Time frame: 12 months

  18. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Aspartate Transferase (AST)

    Time frame: 12 months

  19. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Gamma Glutamyl Transferase (GGT)

    Time frame: 12 months

  20. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Albumin

    Time frame: 12 months

  21. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Lipid Profile - Cholesterol, triglycerides, low density lipoprotein, high density lipoprotein (all mg/DL)

    Time frame: 12 months

  22. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Bone profile - Parathyroid hormone (PTH)

    Time frame: 12 months

  23. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Bone profile - Calcium and Phosphate (mmol)

    Time frame: 12 months

  24. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Bone profile - Alkaline Phosphatase (ALP) (U/L)

    Time frame: 12 months

  25. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Bone profile - Vitamins A and E (ummol/L)

    Time frame: 12 months

  26. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Bone profile - Vitamin D (nmol/L)

    Time frame: 12 months

  27. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Thyroid function tests - T3 and T4 (pmol/L)

    Time frame: 12 months

  28. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Thyroid function tests - Thyroid Stimulating Hormone (TSH) (mU/L)

    Time frame: 12 months

  29. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    luteinizing hormone (LH), follicle stimulating hormone (FSH) (u/L)

    Time frame: 12 months

  30. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Testosterone, sex hormone binding globulin (nmol/L)

    Time frame: 12 months

  31. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Oestradiol (pmol/L)

    Time frame: 12 months

  32. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Changes in imaging markers such as liver fat on MRI

    Time frame: 12 months

  33. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Changes in metabolic disease based on DXA scan

    Time frame: 12 months

  34. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Changes in bone mineral density based on DXA scan

    Time frame: 12 months

  35. What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.

    Changes in body composition based on DXA scan

    Time frame: 12 months

  36. What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents.

    Change in eating disorder score or development of eating disorders and binge eating, assessed via the Eating Disorder Examination Questionnaire EDE-Q/EDE-A.

    Time frame: 12 months

  37. What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents.

    Change in psychological outcomes via the Generalised Anxiety Disorder Assessment (GAD-7).

    Time frame: 12 months

  38. What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents.

    Change in psychological outcomes via the Revised Children's Anxiety and Depression Scale (RCAS).

    Time frame: 12 months

  39. What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents.

    Change in health-related quality of life via Child Health Utility instrument (CHU9D).

    Time frame: 12 months

  40. What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents.

    Change in health-related quality of life via the paediatric quality of life inventory - PedsQL 3.2.

    Time frame: 12 months

  41. What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents.

    Change in health-related quality of life via EQ-5D-Y, a standardised measure adapted for use with young people.

    Time frame: 12 months

  42. What are the positive and potential negative effects of a period of LED on the behavioural wellbeing of adolescents.

    Change in activity via activity monitors.

    Time frame: 12 months

  43. What are the positive and potential negative effects of a period of LED on the behavioural wellbeing of adolescents.

    Change in activity through self-report via Physical Activity Questionnaire (PAQ-A/PAQ-C).

    Time frame: 12 months

  44. What are the positive and potential negative effects of a period of LED on the behavioural wellbeing of adolescents.

    Acceptability of the intervention from semi-structured interviews conducted with participants and their family/carer, simultaneously.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for May 2028, 34 months after the start.

Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 34 months is above that.

Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2024
First posted
Aug 27, 2024
StartActual
Jun 30, 2025
Primary completionEst.
May 29, 2028
CompletionEst.
May 29, 2028
Last update
Jul 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06572345
Lead sponsor
Nottingham University Hospitals NHS Trust
Collaborators
Diabetes UK
Responsible party
Sponsor
First posted
Aug 27, 2024
Start date
Jun 30, 2025
Primary completion
May 29, 2028 (estimated)
Completion
May 29, 2028 (estimated)
Last update
Jul 9, 2026

Study contacts

Pooja Sachdev, MD
Contact
pooja.sachdev@nhs.net
0115 924 9924 ext. 82367
Gemma Boam, PhD
Contact
gemma.boam@nhs.net

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pediatric Obesity →

Other studies from this sponsor

Nottingham University Hospitals NHS Trust →

Start the discussion