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

NCT06572345 | Recruiting

• 3 other identifiers: 22CS00721/0006341317544
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Pediatric Obesity

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  12 months

• 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)

  12 months

• 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)

  12 months

• 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)

  12 months

Secondary Outcomes (44)

• Proportion of participants that adhere to the LED

  12 weeks

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

  12 months

• 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).

  12 months

• 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).

  12 months

• Adverse effects

  12 months

Study Arms (1)

Low Energy Diet (LED)

EXPERIMENTAL

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

Low-energy diet DIETARY_SUPPLEMENT

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.

Low Energy Diet (LED)

Qualitive interview - LED participants OTHER

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

Low Energy Diet (LED)

Qualitive interview - Participants declining LED OTHER

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

Low Energy Diet (LED)

Qualitive interview - Health Care Professionals (HCPs) OTHER

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

Low Energy Diet (LED)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• LED intervention
• 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. 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.
• BMI ≥981st 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 engage in and commit to low energy diet, FR and weight management phases including follow-up and attending study visits.
• LED Intervention Interviews
• 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.

You may not qualify if:

• LED intervention
• HbA1C 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 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 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.
• Non-LED Qualitative Interview only participants
• HbA1C greater than 80mmol/mol.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• Diabetes UK: collaborator

Study Sites (1)

Nottingham University Hospital NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Diabetes Mellitus, Type 2; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Pooja Sachdev, MD

CONTACT

0115 924 9924; pooja.sachdev@nhs.net

Gemma Boam, PhD

CONTACT

gemma.boam@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 73 participants in total: * Thirty-three participants to trial the LED intervention * Ten participants from the LED intervention and their parents/carers for the interviews. * Ten dyads undertaking interviews only (1 adolescent and 1 parent/carer) who declined the intervention. * Ten healthcare practitioners (interviews only).

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: August 27, 2024
• Study Start: June 30, 2025
• Primary Completion (Estimated): May 29, 2028
• Study Completion (Estimated): May 29, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

GB (1)