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

NCT ID: NCT05249439

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-29
• Study Completion Date: 2019-05-02

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 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:

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

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I-SatPro

Patients in the I-SatPro group will attend I-SatPro patient group weight management sessions (Tier 3 equivalent) and follow the I-SatPro programme

Group Type: EXPERIMENTAL

I-SatPro weight loss programme

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Tier 3 weight loss programme

Intervention Type: 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.

Interventions

I-SatPro weight loss programme

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.

Intervention Type: OTHER

Tier 3 weight loss programme

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tricia Tan, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

References

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.

Reference Type: RESULT

PMID: 32991078 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

189449

Identifier Type: OTHER

Identifier Source: secondary_id

16/LO/1622

Identifier Type: OTHER

Identifier Source: secondary_id

16HH3487

Identifier Type: -

Identifier Source: org_study_id