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

NCT07283978 | Enrolling By Invitation

• 1 other identifier: 351778
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight; Obesity

Keywords

Weight Management; Digital Weight Management; Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage of weight change at 12 months

  Baseline and 12 months

• Quality of Life as a measure to determine cost-effectiveness

  Quality of Life will be measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire

  Baseline and 12 months

Secondary Outcomes (22)

• Feasibility of implementing the intervention into Tier 3 weight management pathways

  Once

• Acceptability of implementing the intervention into Tier 3 weight management pathways

  Once

• Uptake of the intervention

  12 months

• Retention in the intervention programme

  From enrolment until the end of the intervention at 12 months /withdrawal/dropout

• Success in the intervention programme

  From enrolment until the end of the intervention at 12 months

Study Arms (4)

Group A Intervention

ACTIVE COMPARATOR

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

Other: Digital Weight Management Programme

Group B Intervention

ACTIVE COMPARATOR

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

Other: Digital Weight Management Programme

Group A Controls

NO INTERVENTION

Patients who receive standard of care weight management services

Group B Controls

NO INTERVENTION

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

Interventions

Digital Weight Management Programme OTHER

Digital Weight Management Programme

Group A Intervention; Group B Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy' & St Thomas' NHS Foundation Trust

London, Greater London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Walker, PhD

  Guy's and St Thomas' NHS Foundation Trust

  STUDY CHAIR

• Emma Duncan, MD, PhD

  King's College London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 16, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

GB (1)