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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
I-SatPro weight loss programme
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Tier 3, weight-loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    I-SatPro

    Control

    Arm Description

    Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme

    Patients in the control group will attend NHS Tier 3 patient group sessions and follow the NHS Tier 3 weight loss programme

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Energy expenditure (how efficiently your body burns calories)
    Measurement of whether the dietary intervention changes the rate at which your body burns calories
    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
    Change in blood pressure
    Measuring patients' blood pressure to see if it changes
    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
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    November 22, 2021
    Last Updated
    July 12, 2023
    Sponsor
    Imperial College London
    Collaborators
    Imperial College Healthcare NHS Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05249439
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    November 29, 2016 (Actual)
    Primary Completion Date
    January 2019 (Actual)
    Study Completion Date
    May 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperial College London
    Collaborators
    Imperial College Healthcare NHS Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Obesity, Tier 3, weight-loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I-SatPro
    Arm Type
    Experimental
    Arm Description
    Patients in the I-SatPro group will attend I-SatPro patient group sessions and follow the I-SatPro weight loss programme
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Patients in the control group will attend NHS Tier 3 patient group sessions and follow the NHS Tier 3 weight loss programme
    Intervention Type
    Other
    Intervention Name(s)
    I-SatPro weight loss programme
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Change in weight will be measured from patient group session 1 (week 0) to the end of study (week 52)
    Time Frame
    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 Measure Information:
    Title
    Energy expenditure (how efficiently your body burns calories)
    Description
    Measurement of whether the dietary intervention changes the rate at which your body burns calories
    Time Frame
    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)
    Title
    Body weight composition - how much of your weight is body fat?
    Description
    Percentage body fat can be checked when weight is checked on specialised weighing scales
    Time Frame
    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.
    Title
    Change in blood pressure
    Description
    Measuring patients' blood pressure to see if it changes
    Time Frame
    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.
    Title
    Change in blood sugar levels (changes in the blood test marker for diabetes called HbA1c)
    Description
    Checking blood tests before and after taking part to look for these blood test changes
    Time Frame
    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)
    Title
    Measurement of eating patterns, hunger levels and relationship with food
    Description
    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
    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).
    Title
    Measurement of eating patterns, hunger levels and relationship with food
    Description
    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.
    Time Frame
    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).
    Title
    Measurement of wellbeing and quality of life
    Description
    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.
    Time Frame
    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).
    Title
    Patient drop-out rate
    Description
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tricia Tan, MBChB, PhD
    Organizational Affiliation
    Imperial College London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32991078
    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.
    Results Reference
    result
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/32991078/
    Description
    Publication of study methods and results

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

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