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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249439
• Other study ID #: 16HH3487
• Secondary ID: 18944916/LO/1622
• Status: Completed
• Phase: N/A
• Start date: November 29, 2016
• Est. completion date: May 2, 2019

Study information

• Verified date: July 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Description:

The purpose of the study is to check whether, compared to a standard NHS Tier 3 weight loss programme:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• I-SatPro weight loss programme
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

References & Publications (1)

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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Change in weight will be measured from patient group session 1 (week 0) to the end of study (week 52)	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	Energy expenditure (how efficiently your body burns calories)	Measurement of whether the dietary intervention changes the rate at which your body burns calories	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)
Secondary	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	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.
Secondary	Change in blood pressure	Measuring patients' blood pressure to see if it changes	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.
Secondary	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	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)
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	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).
Secondary	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.	Patient drop out will be recorded from the first patient group session (week 0) to the end of the study (week 52).

External Links

•   Publication of study methods and results