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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Retention rate measured by by data availability for participant HbA1C.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •The same interview inclusion criteria for LED intervention, with the following additional requirements:
- •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.
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: Low-energy diet (Dietary Supplement)
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.
干预措施: Qualitive interview - LED participants (Other)
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.
干预措施: Qualitive interview - Participants declining LED (Other)
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.
干预措施: Qualitive interview - Health Care Professionals (HCPs) (Other)
结局指标
主要结局
Retention rate measured by by data availability for participant HbA1C.
时间窗: 12 months
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)
Proportion of potential participants that can be recruited to an LED intervention
时间窗: 12 months
Number of eligible participants identified compared to those consented, passed screening and started on LED intervention.
Retention rate measured by by data availability for participant height.
时间窗: 12 months
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)
Retention rate measured by by data availability for participant weight.
时间窗: 12 months
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)
次要结局
- What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents.(12 months)
- What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents.(12 months)
- What are the positive and potential negative effects of a period of LED on the behavioural wellbeing of adolescents.(12 months)
- Degree of weight loss achieved in those who adhere to the LED and if this is maintained at 12-months.(12 months)
- Is the study, including the intervention, investigations and assessments, deliverable consistently across different sites using the standardised study resources.(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)
- Proportion of participants that adhere to the LED(12 weeks)
- Which biomarkers and pathways are upregulated and which are downregulated in young people with T2DM and what is the response to an LED intervention.(12 months)
- What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.(12 months)
- 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)
- Adverse effects(12 months)
- Is the study, including the intervention, investigations and assessments, deliverable consistently across different sites using the standardised study resources.(12 months)
- Which biomarkers and pathways are upregulated and which are downregulated in young people with T2DM and what is the response to an LED intervention.(12 months)
- What are the positive and potential negative effects of a period of LED on the biological wellbeing of adolescents.(12 months)
- What are the positive and potential negative effects of a period of LED on the psychological wellbeing of adolescents.(12 months)
- What are the positive and potential negative effects of a period of LED on the social wellbeing of adolescents.(12 months)
- What are the positive and potential negative effects of a period of LED on the behavioural wellbeing of adolescents.(12 months)