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
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.
∙ 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.
• Aged 12 to 17 years old.
• BMI ≥98th 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
∙ 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 ≥98th 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.