Investigation of a New Diet for the Treatment of Obesity in the NHS
Phase: NA
Conditions: Obesity
Sponsor: Imperial College London

1 
 
Section of Endocrinology and Investigative Medicine 
Department of Metabolism, Digestion and Reproduction 
Imperial College London 
London W12 0NN, UK 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL 
 
COVER PAGE 
 
 
Official Title: Investigation of a New Diet for the Treatment of Obesity in the NHS 
 
Brief Title: Investigation of a New Diet for the Treatment of Obesity in the NHS 
 
Study Type: Interventional 
 
NCT number: NCT05249439 
 
Sponsor: Imperial College London, London, UK 
Document Date: 12th June 2018 
 
 
 

2 
 
 
 
 
 
 
 
 
Background 
The obesity epidemic shows no sign of abating. In the UK in 1980, 6% of men and 8% of women were obese. Today, 
this has risen to 25% of all British adults with the cost of treating obesity and its co-morbidities estimated at £5.1 
billion per year. The national obesity figures tell us that the standard low calorie ‘eat less’ advice is not working and 
there is, therefore, a need to improve the dietary advice given to obese patients if we are to stem the epidemic of 
obesity seen in the UK today. 
 
The NHS advises a low calorie diet as the mainstay of obesity treatment. Most low calorie diets fail because when 
food intake falls, the body launches a powerful hormone counter-response that makes people hungry and which 
reduces the rate at which they burn energy (refs 1-3). This means that despite the NHS’s advocacy of ‘lifestyle’ (i.e. 
dietary) measures as the cornerstone of obesity treatment, the advice being given will only work long term for a 
small minority of patients. 
 
At the Imperial Weight Centre (IWC), Imperial College Healthcare NHS Trust (ICHNT), we currently manage obese 
patients in a specialist weight management programme known as Tier 3. Outcomes from patients following a 
standard NHS low calorie (LowCal) diet, who have recently completed our six month Tier 3 programme show that 
they fail to lose the requisite amount of weight to confer improvements in metabolic and cardiovascular health. In 
addition, we have data to show that patients following a low calorie diet have a reduced metabolic rate (the speed at 
which they burn energy).  
 
Using the scientific literature we have developed a new fullness (satiety) inducing diet called Satiety Protocol 
(SatPro). The advice given in SatPro aims to increase fullness after eating and reduce feelings of hunger, therefore 
working with, rather than against the body’s hunger-fullness system. In addition, unlike low calorie diets, SatPro 
does not ask patients to markedly reduce their caloric intake and we would therefore predict that SatPro will not 
lead to the same fall in metabolic rate seen with low calorie diets. 
 
SatPro consists of five pieces of eating advice. Individually each piece of advice given in SatPro is followed by humans 
every day without reported adverse effects. SatPro does not require any special foods, supplements, medicines, 
equipment or facilities. Patients following SatPro will be eating foods that are commonly available to the general 
public (e.g. in the supermarket) all of which are subject to government regulation (e.g. freshness, constituent 
Study Protocol: Version 4, 12th June 2018   
(IRAS ID: 189449; REC reference 16/LO1622) 
Investigation of a new satiety inducing diet for the treatment of obesity in the NHS 

3 
 
ingredients etc.). 
 
The scientific background for SatPro is laid out below:  
 
SatPro versus LowCal: 
 
1. 
LowCal: Reduce intake by 600kcal/day. 
Evidence: Low calorie diets fail because they elicit hormonal changes that promote hunger and reduce metabolic 
rate (the rate at which the body burns energy) (ref 1-3).   
SatPro: The scientific evidence (points 2-6 below) predicts that SatPro should not result in these hunger-inducing 
hormonal changes. Eat when you feel hungry. Stop when you feel full. 
 
2. 
LowCal: Consume some protein (12% of intake/day). 
Evidence: Protein promotes post-prandial fullness by stimulating a rise in circulating pro-satiety gut hormones, 
superior to that of any other macronutrient (ref 4).  
SatPro: Eat protein (45g) at each meal (35% of intake/day). 
 
3. 
LowCal: Eat plenty of starchy foods including bread, potatoes rice and pasta. 
Evidence: Glycaemic index (GI) characterises the increment in blood glucose (BG) following carbohydrate 
consumption (ref 5). Starchy foods are high GI and require high levels of the pro-fat storage hormone insulin to 
normalise BG. 
SatPro: Eat low GI carbohydrates (GI value <55) to keep insulin levels low, a physiological state that promotes fat 
breakdown (lipolysis) and inhibits fat storage (lipogenesis) (ref 6) and which results in increased post-prandial 
satiety. 
 
4. 
LowCal: Occasional 'treats' permitted. 
Evidence: High sugar foods stimulate a hedonic response that can cause cravings and uncontrolled eating (ref 7). 
SatPro: Abstain completely from foods that trigger this hedonic response (an approach that is akin to the NHS advice 
on smoking cessation). 
 
5. 
LowCal: Eat a low fat diet 
Evidence: Dietary fat is satiating and certain fats have metabolic and cardiovascular health benefits (refs 8,9). In 
addition, 'low fat' diet foods frequently replace fat with sugar or other poor quality carbohydrates (ref 10) (see point 
3 above). 
SatPro: Eat up to 90g/day of certain fats with health benefits (refs 8,9) e.g. olive oil and nuts. Do not eat 'diet', 'light' 
or 'low fat' processed foods (see also point 6 below).  

4 
 
This feasibility study will assess whether SatPro results in superior weight loss in obese patients compared with 
patients following standard low calorie advice (LowCal). We will also assess whether patients who lose weight on 
SatPro can do so without the reduction in metabolic rate that is seen in patients following LowCal. Lastly, we will 
investigate the mechanisms by which SatPro works. We have hypothesised that SatPro might work for the following 
reasons: 
a. It causes levels of ‘fullness’ gut hormones to run high and ‘hunger’ gut hormones to run low.  
b. It induces changes in the gut bacteria (gut microbiome) that promote a leanness and which lead to 
reduced appetite 
It is not be associated with the fall in basal metabolic rate that is often seen in weight loss diets and which results in 
weight re-gain. 
 
Inclusion Criteria: 
• 
Aged ≥18 years 
• 
Male or female 
• 
Body mass index ≥35kg/m2 with at least one obesity related co-morbidity  
• 
Body mass index ≥40kg/m2 with or without an obesity related co-morbidity  
• 
Eligible for treatment under the NHS 
Exclusion criteria: 
• 
History of any medical, psychological or other condition, or use of any medications, which would either 
compromise the validity of the study or the safety of the participant 
• 
English language fluency and/or comprehension insufficient to be able to participate in educational and 
group components of the programme 
• 
Usual residence/place of work is sufficiently far from the study site or logistical/lifestyle factors mean that it 
is likely that the patient would be unable to attend for all sessions/components of the study 
• 
Pregnancy or breast feeding 
• 
Previous bariatric surgery 
• 
Concurrent participation in another research study which would either compromise the validity of the study 
or the safety of the participant 
• 
Previous participation in a study at any time point if the investigators judge that this would either 
compromise the validity of the study or the safety of the participant 
• 
Unable to give informed consent 
 
Protocol (Please also refer to Study Protocol, figure 1 and to table 1) 
 
 

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Study Overview 
Feasibility study of SatPro conducted in obese patients seen for specialist weight management (Tier 3 Programme) in 
the Imperial Weight Centre, ICHNT.  
 
Patients 
Potential participants will be identified and recruited from obese patients referred to the Imperial Weight Centre, 
ICHNT for Tier 3 specialist weight management. All patients will be registered at ICHNT. 
 
BACKGROUND: 
 
Existing Imperial Weight Centre (IWC) Tier 3 Weight Management Programme: 
 
NICE guidance states that obese people should be seen within a multidisciplinary specialist weight management 
service known as Tier 3 in which they receive specialist medical, dietetic and psychological input. 
 
In the existing (currently running) NHS Tier 3 programme at the Imperial Weight Centre (IWC), Imperial College 
Healthcare NHS Trust (ICHNT) patients proceed through the Tier 3 pathway follow a step wise progression through 
the Tier 3 programme as detailed in points 1 to 4 below: 
 
Current IWC Tier 3 Pathway 
 
1. Patients attend for one to one consultations with each of the specialist obesity dietician, psychologist and 
physician. 
 
2. Patients attend for ten fortnightly group weight management sessions (n= 8 - 10 patients) facilitated by the 
multidisciplinary IWC team lasting for a total of 20 weeks. During these sessions patients receive ongoing advice and 
support in helping them adhere to the standard NHS low calorie diet (LowCal).  
 
3. After the final (tenth) group session, a member of the IWC multi-disciplinary team meets with the patient for a 
one to one exit appointment to discuss their Tier 3 weight and health outcomes and to agree on a plan for their 
future weight management. 
 
4. Following on from this exit meeting, a minority of patients will be referred for bariatric (weight loss) surgery and 
the rest are discharged back to primary care or community based weight loss services. 
 
 

6 
 
How this SatPro Pilot Study will fit in: 
 
Pre-registration: 
 
1. Patients will be informed about the study by letter, telephone call, email or at the one to one consultation with a 
member of the Imperial Weight Centre multi-disciplinary team. A patient information sheet will be given to patients. 
Patients will be given at least 24 hours to decide whether they wish to take part in the study. 
2. A member of the Imperial Weight Centre multi-disciplinary team will ask the patient if they wish to take part in the 
study. If the patient wishes to take part in the study they will subsequently be contacted by a study investigator to 
make arrangements for the screening visit. 
Those patients referred for NHS Tier weight management who do not wish to take part in the study will progress 
through the usual Tier 3 pathway as described in points 1 to 4 above. 
 
3. Screening visit and informed consent: The patient will have the opportunity to ask questions and to discuss the 
study with the investigator. If the patient wishes to proceed, informed consent will be taken at this visit (this will be 
done at least 24 hours after receipt of the patient information sheet). This will be done by the patient reading the 
study consent form. They will be asked to initial each point on the form to indicate that they have read, understood 
and been given the opportunity to ask questions. Once all points on the consent form have been initialled by the 
patient, the patient will sign the consent form. The consent form will then be co-signed by the investigator 
conducting the consultation. 
All participants will be screened to assess whether they meet inclusion criteria and this process will comprise a 
medical history, routine physical examination and fasting blood tests.  
Patients will be required to fast overnight (12 hours) prior to blood tests. Patients can drink plain water while fasting. 
Fasting blood tests will be taken for full blood count, iron studies, folate, vitamin B12, renal function, liver function 
tests, bone profile, vitamin D, thyroid function, glucose, insulin, C-peptide, HbA1c, lipids. 
All women of child bearing age will be asked to undergo testing for pregnancy by measurement of the urine 
concentration of beta human chorionic gonadotrophin (beta-hCG). The test will be deemed negative for pregnancy if 
beta-hCG cannot be detected.The test will be deemed positive for pregnancy if beta-hCG is detectable at any level. 
 
Study Protocol: 
All patients recruited into this study will receive standard structured Tier 3 care described in points 1 to 4 above.  
In addition to standard care all participants will be required to participate in the following 
visits/measurements/assessments (which are in excess of what they would normally experience in the standard Tier 
3 experience) (Please also refer to Study Protocol, figure 1 and to table 1): 
 
1. An initial study visit (Study Visit A) lasting for a total of 4.5 hours.  
At Study Visit A the following baseline assessments will be recorded:  
Body weight, height, body mass index, body composition (using bio-impedance weighing scales), blood pressure 
(three seated readings) and hip, waist and neck circumference (measured with a tape measure).  

7 
 
Blood tests for fasting gut hormones 
Resting energy expenditure will be measured by indirect calorimetry. 
The patient will be asked to provide a mid-stream urine sample. From this, two 10ml urine samples will be aliquoted. 
One 10ml sample to be analysed for urinary by-products of metabolism. The second 10ml urine sample will be 
analysed for urinary urea (a waste product of protein metabolism) which is necessary to measure in order to 
accurately calculate resting energy expenditure as measured by indirect calorimetry. 
During Study Visit A, patients will be asked to complete the following questionnaires: 
• 
Dutch Eating Behaviour Questionnaire (30 minutes) 
• 
SF-36 health and well-being questionnaire (30 minutes) 
• 
Life experiences questionnaire (45 minutes) 
• 
Three factor hunger questionnaire (30 minutes) 
At Study Visit A, patients will be given a 7-day food diary and a 7-day food expenditure diary to complete at home. 
At Study Visit A, patients will be given a a stool specimen pot and will be asked to collect  a stool specimen at home 
within 24 hours of the first group weight management session. Patients will return the stool sample to the research 
team at the first group weight management session. 
 
2. Patients will be randomised to the SatPro group or to the Control group using a randomisation table generated by 
an independent researcher in our department. 
 
3. At the fourteen fortnightly group weight management sessions (a total of 26 weeks), the Control group following 
the standard NHS Low Calorie diet (LowCal) will be supported to follow this diet. LowCal is based on reducing caloric 
intake and following a low fat diet. 
 
At the fourteen fortnightly group weight management sessions (a total of 20 weeks), the group following SatPro will 
be supported to follow the eating principles of SatPro. 
 
Summary of SatPro dietary advice: 
1. Eat when you feel hungry. Stop when you feel full. 
2. Eat protein (~45g) at each meal. 
3. Eat low glycaemic index (GI) carbohydrates, e.g. fruits, vegetables, wholegrains and pulses. 
4. Abstain completely from foods that trigger a hedonic (excessive reward) response e.g. high sugar foods. 
5. Eat healthy fats. 
 
 
Example SatPro daily menu: 
Breakfast: Scrambled eggs (2 eggs cooked with whole milk and butter), grilled kippers 
 
Lunch: Chicken legs baked with lemon and oregano. Steamed broccoli, cooked red lentils 

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Plain yoghurt with roasted nuts 
 
Dinner (evening meal): Frozen cod fillet with mixed herbs baked with olive oil. Green beans, stir-fried bean 
 
sprouts  
Strawberries 
 
3. At each fortnightly group weight management session the following will be measured in both groups (LowCal and 
SatPro): 
Anthropometrics: body weight, body composition (measured by bio-impedance scales), blood pressure (three seated 
mesaurements) 
4. During the course of the study, both the Control group and SatPro group will be asked to complete the following: 
 
i. A 7-day food diary to be completed by the patient at home on three separate occasions during the study period 
(baseline [to be returned at group weight management session 1], after session five of the fourteen group weight 
management sessions [to be returned at group weight management session 6] and during the follow-up period, 48 
weeks after starting the group weight management sessions, [to be returned at week 50 follow-up visit]).  
 
ii. A 7-day food expenditure diary (listing all food expenditure for 7 days) to be completed by the patient at home on 
two separate occasions during the study (baseline [to be returned at group weight management session 1], and after 
session six of the ten group weight management [to be returned at group weight management session 6]). 
 
iii. An end of study questionnaire (at Study Visit C) which will take 30 minutes to complete. 
 
5. At the final (fourteenth) group weight loss session, patients will be given a stool specimen pot and will be asked to 
collect a stool sample at home within 24 hours of Study Visit B. Patients will return the stool sample to the research 
team at Study Visit B 
 
6. After the patient has completed the last specialist group weight management session (session 14) they will be 
asked to attend for Study Visit B which will last for a total of 3.5 hours.  
At Study Visit B the following assessments will be recorded:  
Body weight, body mass index, body composition (using bio-impedance weighing scales), blood pressure (three 
seated readings) and hip, waist and neck circumference (measured with a tape measure).  
Patients will be required to fast overnight (12 hours) prior to blood tests. Patients can drink plain water while fasting. 
Fasting blood tests will be taken for full blood count, iron studies, folate, vitamin B12, renal function, liver function 
tests, bone profile, vitamin D, thyroid function, glucose, insulin, C-peptide, HbA1c, lipids, gut hormones. 
Resting energy expenditure will be measured by indirect calorimetry. 
The patient will be asked to provide a mid-stream urine sample. From this, two 10ml urine samples will be aliquoted. 
One 10ml sample will be analysed for urinary by-products of metabolism. The second 10ml urine sample will be 
analysed for urinary urea (a waste product of protein metabolism) which is necessary to measure in order to 
accurately calculate resting energy expenditure as measured by indirect calorimetry. 

9 
 
At Study Visit B patients will be asked to complete: 
• 
Dutch Eating Behaviour Questionnaire (30 minutes) 
• 
SF-36 health and well-being questionnaire (30 minutes) 
• 
Three factor hunger questionnaire (30 minutes) 
7. After Study Visit B, patients will be asked to patients will be asked to attend for five months for twice monthly 
checks of anthropometrics (body weight, percentage body fat) and blood pressure (three seated readings). At the 
last monthly follow up visit, patients will be given a stool specimen pot and will be asked to collect a stool sample at 
home within 24 hours of Study Visit C. Patients will return the stool sample and the urine sample to the research 
team at Study Visit C. 
 
8. One year after starting the study (week 52), patients will be asked to attend for the End of Study Visit, Study Visit 
C.  
At Study Visit C the following assessments will be recorded:  
Body weight, body mass index, body composition (using bio-impedance weighing scales), blood pressure (three 
seated measurements) and hip, waist and neck circumference (measured with a tape measure).  
Patients will be required to fast overnight (12 hours) prior to blood tests. Patients can drink plain water while fasting. 
Fasting blood tests will be taken for full blood count, iron studies, folate, vitamin B12, renal function, liver function 
tests, bone profile, vitamin D, thyroid function, glucose, insulin, C-peptide, HbA1c, lipids, gut hormones. 
Resting energy expenditure will be measured by indirect calorimetry. 
The patient will be asked to provide a mid-stream urine sample. From this, two 10ml urine samples will be aliquoted. 
One 10ml sample will be analysed for urinary by-products of metabolism. The second 10ml urine sample will be 
analysed for urinary urea (a waste product of protein metabolism) which is necessary to measure in order to 
accurately calculate resting energy expenditure as measured by indirect calorimetry. 
At Study Visit C patients will be asked to complete: 
• 
Dutch Eating Behaviour Questionnaire (30 minutes) 
• 
SF-36 health and well-being questionnaire (30 minutes) 
• 
Three factor hunger questionnaire (30 minutes) 
• 
End of Study Questionnaire 
 
END OF STUDY 
 
 

10 
 
Figure 1 –SatPro Study Protocol 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients informed about study. 
Patient information sheet (PIS) given to patient (and opportunity to discuss with researchers) 
Patient referred for multidisciplinary weight management at the Imperial Weight Centre  
Fourteen fortnightly group weight management sessions for a total of 26 weeks.  
At first session patient hands in stool specimen, 7  day food diary and food expenditure diary 
                                                          During these sessions patients receive ongoing advice and support in following the assigned diet 
(LowCal [Control] or SatPro)  
Measurement of body weight, body composition and blood pressure at each session 
Patients complete 7 day food diary after session 5. Hand in at session 6 
 Patients complete 7 day food expenditure diary after session 6. Hand in at session 7 
At the final (fourteenth) session patient given stool specimen pot to take home 
Data collection as per Table 1 below 
Study Visit A: Baseline anthropometric measures, blood pressure, measurement of resting energy expenditure 
by indirect calorimetry, mid-stream urine sample, questionnaires, Patient given food diary, food expenditure 
diary.stool specimen pot to take home 
Patient attends one-to-one consultations with IWC specialist multi-disciplinary team 
Patient states whether they wish to take part in study 
Study Visit B: Anthropometric measures, blood pressure, measurement of resting energy expenditure by 
indirect calorimetry, mid-stream urine sample, questionnaires 
Patient hands in stool specimen 
End of study exit meeting with patient – plans for future management 
END OF STUDY 
Screening Visit: Fasting blood tests, urine pregnancy test, medical history and examination  
Patient signs informed consent form (at least 24 hours after receiving PIS) 
 
Twice monthly follow-up assessments (for 5 months):Weight; %body fat; blood pressure 
Patient completes a 7 day food diary at 48 weeks. At final follow up visit patient given stool specimen pot to 
take home 
Study Visit C: End of study assessments 
End of study anthropometric measures, blood pressure, measurement of resting energy expenditure by 
indirect calorimetry, mid-stream urine sample, questionnaires. Patient hands in stool specimen 
 
Allocation to SatPro group or LowCal (Control) group 

11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY JOURNEY
One to one 
consultation 
with 
member of 
IWC MDT 
One to one 
appointment/tel
ephone/email/l
etter
Screening Study 
visit A
Study 
visit B
Study 
visit C
Exit 
appoin
tment
1
2
3
4
5
6
7
8
9
10
11
12
13
14
1
2
3
4
5
6
7
8
9
10
1:1 consultation with IWC MDT
X
X
Patient informed about study
X
X
Patient Information sheet
X
X
Patient asked if they would like to take part
X
Fasting blood tests
X
X
X
Fasting gut hormones (blood test)
X
X
X
Pregnancy test (urinary beta-hCG)
X
History and examination
X
Consent
X
Measurement of body weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Measurement of height
X
Anthropometric assessments body 
composition (bio-impedance)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Waist, hip and neck circumference
X
X
X
Measurement of blood pressure
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Measurement of resting energy expenditure 
by indirect calorimetry
X
X
X
Mid-stream urine sample
X
X
X
Patient given stool specimen pot
X
X
X
Patient hands stool sample
X
X
X
Fortnightly group weight management 
session (14 in total)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Life experiences questionnaire
X
SF-36 Questionnaire
X
X
X
Dutch Eating Behaviour Questionnaire
X
X
X
3 factor eating behaviour questionnaire
X
X
X
Patient given 7 day food diary
X
X
X
Patient hands in 7 day food diary
X
X
X
Patient given 7 day food expenditure diary
X
X
Patient hands in7 day food expenditure diary
X
X
End of study questionnaire
X
 Fortnightly group weight management sessions 
Bi-monthly follow-up sessions
Table 1 : Details of Study Protocol 

12 
 
 
Statistical analysis 
Outcomes will be compared between the SatPro group and patients who have followed a low calorie diet (LowCal).  
Primary outcome: Change in body weight 
Secondary outcomes: 
Change in body composition 
Change in waist to hip ratio 
Change in neck circumference  
Change in blood pressure 
Change in glycaemic control 
Change in energy expenditure 
Satiety, hunger and dietary restraint 
Acceptability to patients 
Diet sustainability/adherence 
Changes in gut and urine microbiome and metabolome 
Changes in hunger and fullness gut hormones 
 
Quantitative data will be analysed using the appropriate statistical software (GraphPad Prism and SPS) in conjunction 
with guidance from the Imperial College Statistical Advisory Service. Comparisons between the LowCal and SatPro 
groups will be performed in an intention to treat manner and sub-stratified where possible. 
 
Qualitative data, for example free text responses in questionnaires, will be subject to thematic analysis based in 
Grounded Theory. Food diaries will be analysed using the appropriate software and food expenditure diaries will be 
analysed using the DEFRA template. 
 
Safety and protection of patients 
 
Clinical care 
All patients, will receive multidisciplinary weight management and will progress through the standard Tier 3 pathway 
that is currently in operation at ICHNT.  
 
Dietary intervention 
SatPro advocates eating foods that are readily available to the general public e.g. from supermarkets and which have 
been subjected to governmental regulation regarding freshness, constituent ingredients etc. Adverse events (see 
below) related to the dietary protocol are not anticipated. 
 
 

13 
 
 
Blood sampling 
Blood will be taken only by an NHS phlebotomist or by a medical practitioner or registered nurse trained in the 
procedure.  
 
Withdrawal from the study 
Patients will be free to withdraw at any point during the study. In addition the investigators will withdraw a patient 
from the study if they have identified clinical grounds for doing so. 
  
Contact information 
Patients will be given contact information for the trial investigators which they can use at any point during the study 
if there has been a change in their clinical condition that they wish to report. This contact cannot be used by patients 
to supplement routine clinical care as this could potentially bias the outcome of the study.  
 
Investigators 
The Chief Investigator is Professor Tricia Tan, Investigative Medicine, Imperial College London and Imperial Weight 
Centre, ICHNT. Co-investigators and collaborators are Dr Saira Hameed, NIHR Clinical Lecturer, Investigative 
Medicine, Imperial College London and Imperial Weight Centre, ICHNT; Professor Sir Stephen Bloom, Head of 
Department of Investigative Medicine, Imperial College London; Dr Harvinder Chahal, Consultant Endocrinologist 
and Lead Bariatric Physician, Imperial Weight Centre, ICHNT, Honorary Clinical Senior Lecturer, Investigative 
Medicine, Imperial College London; Mr Ahmed Ahmed, Consultant Upper GI and Bariatric Surgeon and Clinical Lead 
for Bariatric Surgery, Imperial Weight Centre, ICHNT, Professor Gary Frost, Chair in Nutrition and Dietetics, Imperial 
College London; Miss Rhian Houghton Specialist Obesity Management Dietician, Imperial Weight Centre, ICHNT; Dr 
Meila Roy, Clinical Bariatric Psychologist, Imperial Weight Centre, ICHNT; Dr Victoria Salem, NIHR Clinical Lecturer, 
Investigative Medicine, Imperial College London and Imperial Weight Centre, ICHNT; Dr George Tharakan, Clinical 
Research Fellow, Investigative Medicine, Imperial College London; Dr Alexander Miras, Clinical Senior Lecturer, 
Imperial College London; Dr Samantha Scholtz, Consultant Psychiatrist, Imperial Weight Centre, ICHNT; Ms Haya 
Alessemii, Doctoral Research Student, Investigative Medicine, Imperial College London 
 
Adverse Events 
Definitions 
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect that: 
• 
Results in death 
• 
Is life threatening – refers to an event in which the subject was at risk of death at the time of the event; it 
does not refer to an event which hypothetically might have caused death if it were more severe 

14 
 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
Medical judgement should be exercised in deciding whether an AE serious in other situations. Important AEs that are 
not immediately life-threatening or do not result in death or hospitalisation but may jeopardise the subject or may 
require intervention to prevent one of the other outcomes listed in the definition above, should also be considered 
serious. 
 
Reporting Procedures 
All adverse events should be reported. Depending on the nature of the event the reporting procedures below should 
be followed. Any questions concerning adverse event reporting should be directed to the Chief Investigator in the 
first instance. 
 
Non serious AEs 
All such events, whether expected or not, should be recorded. 
Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours. 
All SAEs should be reported to the Hampstead REC where in the opinion of the Chief Investigator, the event was: 
• 
‘related’, i.e. resulted from the research protocol and 
• 
‘unexpected’, i.e. an event that would not be an expected occurrence of the protocol 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief Investigator becoming 
aware of the event, using the NRES SAE form for non-IMP studies. The Chief Investigator must also notify the 
Sponsor of all SAEs. 
 
Contact details for reporting SAEs 
Fax: 020 8383 8320, attention of: Professor Tricia Tan 
Please send SAE forms to: Section of Investigative Medicine, Division of Diabetes, Endocrinology and Metabolism, 
Imperial College London  
Tel: 020 8383 3242 (Mon to Fr 09.00-17.00h) 
 
Possible Adverse Events 
Patients will be encouraged to report any unusual or unpleasant sensations or new symptoms to the investigator 
immediately. Any significant adverse effects will lead to withdrawal of the individual and any serious adverse effects 
will terminate the whole study. 

15 
 
Throughout the study there will be at least one physician available in case of a possible adverse event. Although we 
do not anticipate any serious adverse effects, patients will be provided with contact details and clear instructions 
that, if they feel unwell, they should contact us. 
It will be made clear to patients that they will be free to withdraw from the study at any time without providing any 
reason. Patients will be given an adverse event form to fill in and this will be reviewed at each attendance. Any 
possible adverse event will then be reviewed with the senior clinicians. Any significant adverse effects would lead to 
withdrawal of the individual and any serious adverse effects would terminate the whole trial. Any serious adverse 
event suspected to be related to the study would be reported to the ethics committee and the sponsor (Imperial 
College London). 
 
Regulatory Issues: 
Ethics approval 
Ethical approvals will be sought by the Chief Investigator from Hampstead REC/HRA. The study will be conducted in 
accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th 
World Medical Assembly, Helsinki 1964 and later revisions. 
 
Consent 
Consent to enter the study must be sought from each participant only after a full explanation has been given, an 
information leaflet offered and time allowed for consideration. The patient will have at least 24 hours after receipt 
of the patient information sheet to decide whether to take part. Signed participant consent should be obtained. The 
right of the participant to refuse to participate without giving reasons must be respected. After the participant has 
entered the study, the clinician remains free to give alternative treatment to that specified in the protocol at any 
stage if he/she feels it is in the participant’s best interest, but the reasons for doing so should be recorded. In these 
cases the patients remain within the study for the purposes of follow up and data analysis. All patients are free to 
withdraw at any time from the protocol treatment without giving reasons and without prejudicing further 
treatment. 
 
Loss of capacity to consent during the study 
If a participant, who has given informed consent, loses capacity to consent during the study, the participant would 
be withdrawn from the study. Identifiable data or tissue already collected with consent would be retained and used 
in the study. No further data or tissue would be collected or any other research procedures carried out on or in 
relation to the participant. Consent for these arrangements in the event of loss of capacity will be explicitly sought in 
the informed consent form. 
 
 
 
 

16 
 
Confidentiality 
The Chief Investigator will preserve the confidentiality of patients taking part in the study. The confidentiality of NHS 
records pertaining to study patients will be maintained as set out in the NHS Confidentiality Policy 2014 
(http://www.england.nhs.uk/wp-content/uploads/2013/06/conf-policy-1.pdf).  
Patient identifiable data will only be accessible to members of the direct care team. Researchers named in this 
application who are not members of the direct care team will only have accessed to anonymised data. A single 
computer file with all personal data will be kept on a password protected Imperial College Healthcare NHS Trust 
(ICHNT) computer. Only data which has been anonymised will be analysed within Imperial College London. 
 
Indemnity 
Imperial College London holds negligent harm and non-negligent harm insurance policies which apply to this study. 
 
Funding 
Dr Hameed is the recipient of BRC Funding Support for NIHR Academic Trainees. The IWC weight management 
programme (Tier 3) service will be funded as per previous NHS funding arrangements.  
 
Audits 
The study may be subject to inspection and audit by Imperial College London under their remit as sponsor and 
other regulatory bodies to ensure adherence to GCP and the NHS Research Governance Framework for Health and 
Social Care (2nd edition).  
 
Study Management 
The day-to day management of the study will be co-ordinated through Professor Tan and Dr Hameed with assistance 
from those named ICHNT medically qualified personnel as well as allied health professionals working within the 
Imperial Weight Centre, ICHNT. A data monitoring committee comprising the trial investigators as well as an external 
assessor will meet on a quarterly basis. The results of the study will be shared with the participants. The study will be 
published in peer review scientific journals.  
 
 
 
 
 
 
 
 
 
 

17 
 
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N Engl J Med (2011) 365:1597 
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N Engl J Med (2008) 359:229 
 
9. 
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Br J Sports Med (2007) 41:126