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

Imperial College London21 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Body Weight Change

Change in body weight will be measured from patient group session 1 (week 0) to the end of study (week 52)

Time frame: First patient group visit (week 0) to end of study (week 52)

Secondary Outcomes

Energy Expenditure (How Efficiently Your Body Burns Calories)

Measurement of whether the dietary intervention changes the rate at which your body burns calories

Time frame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)

Body Weight Composition - How Much of Your Weight is Body Fat?

Percentage body fat as measured using bio-impedance weighing scales Although baseline data were recorded by the study team, inter-individual differences at the same timepoint indicated recorded measure of insufficient reliability to continue to record/report.

Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)

Change in Blood Pressure

Measuring patients' blood pressure to see if it changes

Time frame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)

Change in Blood Sugar Levels (Changes in the Blood Test Marker for Diabetes Called HbA1c)

Change in blood sugar levels measured using the blood test marker for diabetes (glycemic control) called HbA1c

Time frame: Pre-dietary intervention (baseline) and end of study post-dietary intervention (week 52)

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.

Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)

Change in Scores Across the Three Measured Domains (Emotional Eating, External Eating and Restrained Eating) on Dutch Eating Behaviours Questionnaire (DEBQ)

The DEBQ questionnaire completed by study participants to assess eating behaviour across three domains: Emotional eating - eating in response to negative emotions External eating - eating in response to external cues such as the sight or smell of food Restrained eating - the conscious limiting of food intake The DEBQ consists of 33 items grouped into the three categories: emotional eating (13 items), external eating (10 items) and restrained eating (10 items) Participant responses to each item range from 1 (never) to 5 (very often) with higher scores indicating a greater endorsement of the eating behaviour described in the question. The lowest total score for the DEBQ (combined for all three categories) is 33 indicating no behaviours relating to the three domains eating and the highest score is 165 indicating very frequent behaviours relating to the three domains. A lower score indicates healthy eating behaviours, a higher score indicates more problematic eating behaviours.

Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)

Measurement of Wellbeing and Quality of Life

This secondary outcome measures 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. Questions cover the following eight domains: Physical functioning Role limitation due to physical health Role limitation due to emotional problems Energy/fatigue Emotional wellbeing Social functioning Pain General Health Each of these domains is scored from 0 to 100 with a higher score indicating better quality of life and well-being.

Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)

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.

Time frame: Patient drop out will be recorded from the first patient group session (week 0) to the end of the study (week 52).

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes