Investigation of a New Diet for the Treatment of Obesity in the NHS

Study Overview
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Brief Summary
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Over one in four adults living in the UK is living with obesity. Obesity is associated with health complications including type 2 diabetes, heart disease and depression. The current NHS treatment for obesity includes attending a specialist clinic called 'Tier 3' where patients receive help from healthcare professionals such as doctors, dieticians and psychologists. It is known that health conditions associated with obesity improve or reverse if a person with obesity loses 5 per cent or more of their body weight. On average, currently available Tier 3 programmes achieve less weight loss than this. In our specialist obesity clinic at the Imperial Weight Centre, we (the study research team) have designed a new weight loss programme called Imperial Satiety Protocol (or I-SatPro for short). I-SatPro uses the scientific evidence related to weight control, appetite, genes, gut bacteria, hormones, sleep, exercise and behaviour change to create a practical, sustainable weight loss programme for our patients with obesity.

Detailed Description
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The purpose of the study is to check whether, compared to a standard NHS Tier 3 weight loss programme: Our patients like I-SatPro Whether our patients want to follow I-SatPro Check whether our patients following I-SatPro achieve improvements in their health including: weight loss, changes in blood pressure, changes in diabetes control, changes in blood lipids 'cholesterol', changes in their eating patterns and relationship with food, changes in their wellbeing

Official Title
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Investigation of a New Diet for the Treatment of Obesity in the NHS

Conditions
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Obesity

Intervention / Treatment
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* Other: I-SatPro weight loss programme


Participation Criteria
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Eligibility Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups of patients will be recruited from our specialist obesity clinic. One group will take part in the new I-SatPro weight loss programme One group will follow a standard NHS Tier 3 weight loss programme
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-SatPro<br>Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme | Other: I-SatPro weight loss programme<br>* I-SatPro weight loss programme: patients asked to make changes to food choices, the timing of eating, exercise, sleep, eating habits and behaviour changes related to self-care and wellbeing<br>|
| Active Comparator: Control<br>Patients in the control group will attend NHS Tier 3 patient group sessions and follow the NHS Tier 3 weight loss programme | Other: I-SatPro weight loss programme<br>* I-SatPro weight loss programme: patients asked to make changes to food choices, the timing of eating, exercise, sleep, eating habits and behaviour changes related to self-care and wellbeing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Change in weight will be measured from patient group session 1 (week 0) to the end of study (week 52) | Body weight will be assessed at the screening visit, then at the first patient group visit (week 0), then every two weeks until study completion at one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy expenditure (how efficiently your body burns calories) | Measurement of whether the dietary intervention changes the rate at which your body burns calories | Before taking part in the dietary intervention and on completion of the patient group sessions (on average 30 weeks) and at the end of the study (on average 52 weeks) | 
| Body weight composition - how much of your weight is body fat? | Percentage body fat can be checked when weight is checked on specialised weighing scales | Body fat will be measured at the screening visit, then at the first patient group visit (week 0), then every two weeks until study completion at one year. | 
| Change in blood pressure | Measuring patients' blood pressure to see if it changes | Blood pressure will be assessed at the screening visit, then at the first patient group visit (week 0), then every two weeks until study completion at one year. | 
| Change in blood sugar levels (changes in the blood test marker for diabetes called HbA1c) | Checking blood tests before and after taking part to look for these blood test changes | The HbA1c blood test will be checked at the screening visit, then on completion of the patient group sessions (on average 30 weeks) and at the end of the study (on average 52 weeks) | 
| Measurement of eating patterns, hunger levels and relationship with food | Three Factor Hunger Questionnaire: The TFEQ is a 51-item questionnaire completed by study participants to measure three areas (or factors) related to eating behaviour: cognitive restraint of eating (score 0 to 20), disinhibition (score 0 to 16), and hunger (score 0 to 15). The higher the score the greater the level of restrained eating, disinhibited eating and subjective feelings of/predisposition to feeling hungry. | The Three Factor Hunger Questionnaire will be completed at the screening visit, on completion of the patient group sessions (on average 30 weeks) and at the end of the study (on average 52 weeks). | 
| Measurement of eating patterns, hunger levels and relationship with food | Dutch Eating Behaviours Questionnaire: The Dutch Eating Behavior Questionnaire is completed by study participants to assess how different eating styles (emotional eating, external eating and restrained eating) may contribute to weight gain. The questionnaire consists of 33 items and participant responses range from 1 (never) to 5 (very often). The lowest score is 33 and the highest score is 165, with higher scores indicating a greater endorsement of the eating behaviour described in the question. | The Dutch Eating Behaviours Questionnaire will be completed at the screening visit, on completion of the patient group sessions (on average 30 weeks) and at the end of the study (on average 52 weeks). | 
| Measurement of wellbeing and quality of life | These will be assessed using the Short Form-36 (SF-36) questionnaire. SF-36 is a participant completed questionnaire consisting of 36 questions relating to quality of life and well-being. The SF-36 score ranges from 0 to 100 with a higher score indicating better quality of life and well-being. | Patients will complete the SF-36 Questionnaire at the screening visit, on completion of the patient group sessions (on average 30 weeks) and at the end of the study (on average 52 weeks). | 
| Patient drop-out rate | Patient drop out will be recorded. Drop out will be defined as a patient expressing the wish to drop out either verbally or in writing. A patient will also be considered to have dropped out of the study if they do not attend patient group sessions or fail to attend study visits without providing the investigators with an explanation for their non-attendance. Drop-out rate will be used as a surrogate marker of the acceptability of the intervention to patients. | Patient drop out will be recorded from the first patient group session (week 0) to the end of the study (week 52). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Tier 3, weight-loss