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

NCT05249439 | Completed Results DMC

• 3 other identifiers: 16HH348718944916/LO/1622
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Obesity, Tier 3, weight-loss

Outcome Measures

Primary Outcomes (1)

• Body Weight Change

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

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

Secondary Outcomes (8)

• Energy Expenditure (How Efficiently Your Body Burns Calories)

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

• Body Weight Composition - How Much of Your Weight is Body Fat?

  Pre-dietary intervention (baseline) and post-dietary intervention (week 52)

• Change in Blood Pressure

  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)

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

• Measurement of Eating Patterns, Hunger Levels and Relationship With Food

  Pre-dietary intervention (baseline) and post-dietary intervention (week 52)

Study Arms (2)

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

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

Other: Tier 3 weight loss programme

Interventions

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.

I-SatPro

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Related 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 outcomes for people with obesity. Diabetes Obes Metab. 2021 Jan;23(1):270-275. doi: 10.1111/dom.14207. Epub 2020 Oct 15.

  PMID: 32991078 RESULT

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Limitations and Caveats

The dropout rate in the control group (standard Tier 3 care) was too high to feasibly continue this arm of the study. Technical problems with measurement of percentage body fat resulted in unreliable and uninterpretable data.

Results Point of Contact

• Title: Professor Tricia Tan
• Organization: Imperial College London

t.tan@imperial.ac.uk

44 207 594 9048

Study Officials

• Tricia Tan, MBChB, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: February 21, 2022
• Study Start: November 29, 2016
• Primary Completion: January 1, 2019
• Study Completion: May 2, 2019
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share