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Completed

NCT Number: NCT05249439

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

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.

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Key information

About this study

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

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-SatPro weight loss programme

Other

I-SatPro weight loss programme: participants advised on I-SatPro dietary change as well as eating patterns, lifestyle change such as exercise, self-care such as advice on sleep and behavioural change strategies.

Tier 3 weight loss programme

Other

Tier 3 weight loss programme: participants advised to make changes to food choices in accordance with NHS healthy eating advice, eating habits, lifestyle change such as exercise, mindful eating and behavioural change strategies.

Primary outcomes

  1. Body Weight Change

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

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

Secondary outcomes

  1. Energy Expenditure (How Efficiently Your Body Burns Calories)

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

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

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

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

    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.

  3. Change in Blood Pressure

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

    Measuring patients' blood pressure to see if it changes

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

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

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

  5. Measurement of Eating Patterns, Hunger Levels and Relationship With Food

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

    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.

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

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

    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.

  7. Measurement of Wellbeing and Quality of Life

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

    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.

  8. Patient Drop-out Rate

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

    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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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