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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Obesity & Overweight
• Intervention / Treatment: Other: Digital Weight Management Programme

• Study Type: Interventional
• Enrollment (Estimated): 580
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, SE1 9RT
      • Guy' & St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A Intervention; Study participants who receive 12 months of digital weight management services delivered through a smartphone app.	Other: Digital Weight Management Programme; Digital Weight Management Programme
Active Comparator: Group B Intervention; Study participants who receive 12 months of digital weight management services delivered through a smartphone app	Other: Digital Weight Management Programme; Digital Weight Management Programme
No Intervention: Group A Controls; Patients who receive standard of care weight management services
No Intervention: Group B Controls; Patients who receive standard of care service after discharge from standard of care weight management services

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing the intervention into Tier 3 weight management pathways	This will be assessed through qualitative interviews with participants in the Sub-study.	Once
Acceptability of implementing the intervention into Tier 3 weight management pathways	This will be assessed through qualitative interviews with participants in the Sub-study.	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	This will be assessed as clinically significant percentage in weight change of greater than or equal to 5 percent.	From enrolment until the end of the intervention at 12 months
Economic measurements - Quality of Life Years	Quality-Adjusted Life Years (QALYs) associated with weight loss, calculated from the scores on the European Quality of Life 5 Dimensions Level questionnaire (EQ-5D-5L)	Baseline, 6 months, and 12 months
Economics measurements - Resource Use	Resource use covering primary and secondary care services within the National Health Service (NHS)	From enrolment to the end of the intervention at 12 months
Economics measurements - Unit costs	Unit costs obtained from standard sources such as NHS reference costs and Personal Social Services Research Unit's unit costs for health and social care.	From enrolment to end of intervention at 12 months
Economics measurements - Costs between intervention group and standard care group	Costs between intervention group and standard care group with be compared	From enrolment to end of intervention at 12 months
Patient reported outcomes - alcohol use	This will be assessed using a self-reported questionnaire - Alcohol Use Disorders Identification Test (Audit) / scale ranges 0 - 40 / 0=low risk, 20 or more = possible alcohol dependence	At Baseline, 6 months, and 12 months
Patient reported outcomes - patient health	This will be assessed using the self-reported Patient Health Questionnaire-4 (PH-4) / Score range 0 - 12) / Score of 3 or higher further assessment for depression &/or anxiety recommended	Baseline, 6 months, 12 months
Patient reported outcomes - eating pattern	This will be assessed using the self-reported Three-Factor Eating Questionnaire / Score range 1 - 4 for each question / scores are summated into scale scores for cognitive restraint, uncontrolled eating, and emotional eating.	Baseline, 6 months, 12 months
Patient reported outcomes - binge eating	This will be assessed using the self-reported Binge Eating Scale (BES) questionnaire / Score range 0 - 46 / 17 or lower = low binge-eating, 18-26 = mild to moderate binge-eating, 27 or higher = severe binge-eating	Baseline
Patient reported outcomes - physical activity	This will be assess using the self-reported General Practice Physical Activity Questionnaires / Scoring is: Inactive, Moderately inactive, Moderately active, or Active	Baseline if required per clinician assessment
Sub-group analyses- Use of glucagon-like peptide (GLP-1) agonists	Participant use (never/commenced during study/used throughout) of GLP-1 agonsits will be assessed	From enrolment until the end of intervention at 12 months
Sub-group analyses - Adherence	Participant adherence to the intervention will be assessed	From enrolment until drop-out, withdrawal, or end of intervention at 12 months
Sub-group analyses - Comorbidities	Obesity-related medical comorbidities will be assessed	From enrolment until end of intervention at 12 months
Sub-group analyses - Social demographics	Participant social demographics such as sex, ethnicity, age, and Index of Multiple Deprivation (IMD) will be assessed.	At enrolment
Clinical measures - height	Height in metres will be assessed as part of the clinical measures analysis	Baseline
Clinical measures - blood pressure	Self-reported blood pressure will be assessed as part of the clinical measures analysis	Baseline, 6 months, and 12 months
Clinical measures - Body Mass Index	Body Mass Index (BMI) will be assessed from self-reported weight in kilograms divided by height in metres squared, as part of the clinical measures analysis.	Baseline, 6 months, and 12 months
Clinical Measures - waist circumference	Self-reported waist circumference in centimetres will assessed as part of the clinical measures analysis	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London
• Investigators: Study Director: Emma Duncan, MD, PhD, King's College London; Study Chair: Andrew Walker, PhD, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Weight Management; Digital Weight Management
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 351778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No