Clinical trial NCT05249439: Investigation of a New Diet for the Treatment of Obesity in the NHS
Official title: Investigation of a New Diet for the Treatment of Obesity in the NHS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity, Tier 3, weight-loss
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2022-02-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients will be recruited from our hospital obesity clinic. One group will take part in the I-SatPro weight management programme One group will take part in the Tier 3 weight loss programme that is currently offered in our clinical service.
Primary purpose: TREATMENT

Brief summary: 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 hospital weight management service 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 five 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 comprises dietary advice including eating a low carbohydrate (low glycaemic index) diet, eating protein for the satiating effects, eating healthy fats and abstaining from high sugar and/or processed foods which can drive over-eating. Participants will be advised to eat according to subjective feelings of hunger and fullness, rather than eating according to a defined calorie restriction. Similar to other Tier 3 Programmes, I-SatPro also contains locally devised content related to healthy eating, for example fibre intake, the timing of eating, lifestyle change such as exercise, self-care such as advice on sleep and behavioural change strategies.

Detailed description: The purpose of this feasibility/pilot study is to check whether:

1. Our patients like I-SatPro
2. Whether our patients want to follow I-SatPro
3. 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

Eligibility criteria: 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

Primary outcomes:
measure: Body Weight Change
timeFrame: First patient group visit (week 0) to end of study (week 52)
Secondary outcomes:
measure: Energy Expenditure (How Efficiently Your Body Burns Calories)
timeFrame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)
measure: Body Weight Composition - How Much of Your Weight is Body Fat?
timeFrame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
measure: Change in Blood Pressure
timeFrame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)
measure: Change in Blood Sugar Levels (Changes in the Blood Test Marker for Diabetes Called HbA1c)
timeFrame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)
measure: Measurement of Eating Patterns, Hunger Levels and Relationship With Food
timeFrame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
measure: Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ)
timeFrame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
measure: Measurement of Wellbeing and Quality of Life
timeFrame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
measure: Patient Drop-out Rate
timeFrame: Patient drop out will be recorded from the first patient group session (week 0) to the end of the study (week 52).
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Tricia Tan, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hameed S, Salem V, Alessimii H, Scholtz S, Dar O, Miras AD, Meeran K, Bloom SR, Ahmed AR, Purkayastha S, Chahal H, Tan T. Imperial Satiety Protocol: A new non-surgical weight-loss programme, delivered in a health care setting, produces improved clinical outcomes for people with obesity. Diabetes Obes Metab. 2021 Jan;23(1):270-275. doi: 10.1111/dom.14207. Epub 2020 Oct 15.