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RECRUITING
NCT06572345
NA

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

Sponsor: Nottingham University Hospitals NHS Trust

View on ClinicalTrials.gov

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.

Official title: A Multicentre Open-Label, Feasibility Study of the Use of a Short-Term Low-Energy Diet in Adolescents With Obesity and Type-2 Diabetes Mellitus

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

73

Start Date

2025-06-30

Completion Date

2026-12-31

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Low-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.

OTHER

Qualitive interview - LED participants

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

OTHER

Qualitive interview - Participants declining LED

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

OTHER

Qualitive interview - Health Care Professionals (HCPs)

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

Locations (1)

Nottingham University Hospital NHS Trust

Nottingham, United Kingdom