Real-world Exploration of Digital iNnovation in the Management of Excess Weight

NCT ID: NCT07283978

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2027-11-30

Brief Summary

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This is a real-world study. The purpose of this research is to explore whether a new National Institute for Health and Care Excellence (NICE)-approved digital weight-management model of care can improve health service delivery and address the Quintuple Aim of Healthcare (health outcomes, cost, patient and clinician experience, and health inequalities), for individuals living with obesity accessing National Health Service (NHS) Tier 3 weight-management services.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

All participants will receive the same intervention but at different times during their obesity treatment. Group A will receive the intervention while waiting to start standard of care weight management services and Group B will receive the intervention upon discharge from their standard of care weight management services.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group A Intervention

Study participants who receive 12 months of digital weight management services delivered through a smartphone app.

Group Type ACTIVE_COMPARATOR

Digital Weight Management Programme

Intervention Type OTHER

Digital Weight Management Programme

Group B Intervention

Study participants who receive 12 months of digital weight management services delivered through a smartphone app

Group Type ACTIVE_COMPARATOR

Digital Weight Management Programme

Intervention Type OTHER

Digital Weight Management Programme

Group A Controls

Patients who receive standard of care weight management services

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B Controls

Patients who receive standard of care service after discharge from standard of care weight management services

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital Weight Management Programme

Digital Weight Management Programme

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Referred to South east London Tier 3 weight management pathway by their GP
* Accepted by the GSTT Tier 3 weight management service

Exclusion Criteria

* Participants is Group A cannot participate in Group B
* Do not have use of a smartphone
* Do not read, write, or speak English
* Are unable and/or unwilling to provide informed consent
* Have a diagnosis of an eating disorder
* Have had bariatric surgery
* Currently have deranged thyroid function tests (required as part of normal referral process)
* Have type-1 diabetes
* Are on insulin or sulfonylureas at high risk of hypoglycaemia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Walker, PhD

Role: STUDY_CHAIR

Guy's and St Thomas NHS Foundation Trust

Emma Duncan, MD, PhD

Role: STUDY_DIRECTOR

King's College London

Locations

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Guy' & St Thomas' NHS Foundation Trust

London, Greater London, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Julie Foster

Role: CONTACT

+442071887188 ext. 54399

Sponsor Representative

Role: CONTACT

Facility Contacts

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Alastair Duncan, PhD

Role: primary

+442071887188

Julie Foster

Role: backup

+442071887188 ext. 54399

Other Identifiers

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351778

Identifier Type: -

Identifier Source: org_study_id