ObesityNCT05249439
Investigation of a New Diet for the Treatment of Obesity in the NHS
A study testing I-SatPro weight loss programme and Tier 3 weight loss programme in people with Obesity, run by Imperial College London.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- I-SatPro weight loss programme and Tier 3 weight loss programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2016to 2 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the detailed description
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
- Conditions
- Obesity
- Being tested
- I-SatPro weight loss programme, Tier 3 weight loss programme
- Keywords
- Obesity, Tier 3, weight-loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-SatPro weight loss programmeOther
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 programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| I-SatPro | Experimental | Patients in the I-SatPro group will attend I-SatPro patient group weight management sessions (Tier 3 equivalent) and follow the I-SatPro programme Receives: Other: I-SatPro weight loss programme |
| Control | Active comparator | Patients in the control group will attend the established Imperial Weight Centre Tier 3 patient group weight management sessions and follow the Imperial Weight Centre Tier 3 weight management programme Receives: Other: Tier 3 weight loss programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Change
Change in body weight will be measured from patient group session 1 (week 0) to the end of study (week 52)
Measured: First patient group visit (week 0) to end of study (week 52)
Secondary outcomes (8)
Energy Expenditure (How Efficiently Your Body Burns Calories)
Measurement of whether the dietary intervention changes the rate at which your body burns calories
Measured: 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.
Measured: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
Change in Blood Pressure
Measuring patients' blood pressure to see if it changes
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Patient drop out will be recorded from the first patient group session (week 0) to the end of the study (week 52).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start29 Nov 2016
- Primary completionJan 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Tricia Tan, MBChB, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249439
- Sponsor's protocol ID
- 16HH3487
- Other IDs
- 189449, 16/LO/1622
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2021
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32991078
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a New Diet for the Treatment of Obesity in the NHS
- ClinicalTrials.gov ID
- NCT05249439
- Acronym / sponsor ID
- 16HH3487
- Conditions
- Obesity
- Keywords
- Obesity, Tier 3, weight-loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| I-SatPro | Experimental | Other: I-SatPro weight loss programmePatients in the I-SatPro group will attend I-SatPro patient group weight management sessions (Tier 3 equivalent) and follow the I-SatPro programme |
| Control | Active comparator | Other: Tier 3 weight loss programmePatients in the control group will attend the established Imperial Weight Centre Tier 3 patient group weight management sessions and follow the Imperial Weight Centre Tier 3 weight management programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-SatPro weight loss programmeI-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. | Other | I-SatPro |
| Tier 3 weight loss programmeTier 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. | Other | Control |
Primary outcome
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)
8 secondary outcomes
Energy Expenditure (How Efficiently 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?
Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
Change in Blood Pressure
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)
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
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)
Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
Measurement of Wellbeing and Quality of Life
Time frame: Pre-dietary intervention (baseline) and post-dietary intervention (week 52)
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32991078Hameed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tricia Tan, MBChB, PhD principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A study testing I-SatPro weight loss programme and Tier 3 weight loss programme in people with Obesity, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight Change (time frame: First patient group visit (week 0) to end of study (week 52)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05249439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.