Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572345
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-07
Brief Title:
Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes The LEGEND Study
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEGEND
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 DietsLED 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 parentscarers 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 parentscarers 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
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 if80kg at baseline and achieve remission defined as an HbA1C 48 mmolmol three months apart
The LED phase consists of a total meal replacement TMR diet for 12 weeks which contains 800-1000calday with LED diets typically containing 800-1200kcalday and has been previously shown to be safe in young people Available products include shakes soups and bars from providers such as Cambridge 11 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 mmolmol 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 mmolmol 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 parentscarers 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 eg 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 andor 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
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 if80kg at baseline and achieve remission defined as an HbA1C 48 mmolmol three months apart
The LED phase consists of a total meal replacement TMR diet for 12 weeks which contains 800-1000calday with LED diets typically containing 800-1200kcalday and has been previously shown to be safe in young people Available products include shakes soups and bars from providers such as Cambridge 11 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 mmolmol 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 mmolmol 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 parentscarers 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 eg 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None