CORE Study - Research Into Weight Management Services in... | NCT07559409

Studies
CORE Study - Research Into Weight Management Services in the UK

NCT07559409

Sponsor

Society for Endocrinology

Status

Enrolling by invitation

Last Update Posted

May 7, 2026Actual

Enrollment

41,000Estimated

Phase

Not provided

Conditions

Weight Management

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Apr 23, 2026

First Submission Date that Met QC Criteria

Apr 23, 2026

First Posted Date

Apr 30, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Weight management services (previously known as Tier 3 services) represent a multidisciplinary specialist approach, available in community or secondary care settings. This tier caters to individuals with a Body Mass Index (BMI) greater than 35 (or over 30 if they have diabetes) and complex medical conditions, offering pharmacotherapy, low-energy liquid diets, and pre- and post-bariatric surgery care. Tier 4 services, located within secondary care, focus on bariatric surgery.

Data on obesity rates are systematically collected by the National Audit Office, enabling monitoring of Tier 1 effectiveness. Additionally, the National Bariatric Database provides insights into bariatric surgery rates, patient characteristics, and surgical outcomes.

However, comprehensive data on weight management services remain scarce, with information primarily available from only 4 of the 42 weight management clinics. Consequently, it is challenging to ascertain the availability of weight management services across different regions, the volume of referrals, the demographics of individuals accessing these services, and their outcomes during treatment. This lack of data hinders our ability to evaluate equitable access, appropriate referrals, and the overall effectiveness of these services throughout the UK.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To demonstrate that our system can be integrated into NHS specialist weight management clinics and collect data on patients attending clinics.	The number of clinics using the system by end of year 2 of the project. Our aim would be to have 50% of weight management clinics using this system. That the clinics on average are collecting data on 60% of the patients that attend their clinics and on these they have at least 80% data on our key outcomes	24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients able to provide informed consent
Patients able to download and use an English Language app
Patients seen in a weight management service

Exclusion Criteria:

Patients unable to comply with the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All those seen in a weight management service/clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Society for Endocrinology		Bristol			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided