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

April 23, 2026 updated by: Guy's and St Thomas' NHS Foundation Trust
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
580

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of weight change at 12 months
Time Frame: Baseline and 12 months
Baseline and 12 months
Quality of Life as a measure to determine cost-effectiveness
Time Frame: Baseline and 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of implementing the intervention into Tier 3 weight management pathways
Time Frame: Once
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
Time Frame: Once
This will be assessed through qualitative interviews with participants in the Sub-study.
Once
Uptake of the intervention
Time Frame: 12 months
12 months
Retention in the intervention programme
Time Frame: From enrolment until the end of the intervention at 12 months /withdrawal/dropout
From enrolment until the end of the intervention at 12 months /withdrawal/dropout
Success in the intervention programme
Time Frame: From enrolment until the end of the intervention at 12 months
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
Time Frame: Baseline, 6 months, and 12 months
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
Time Frame: From enrolment to the end of the intervention at 12 months
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
Time Frame: From enrolment to end of intervention at 12 months
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
Time Frame: From enrolment to end of intervention at 12 months
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
Time Frame: At Baseline, 6 months, and 12 months
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
Time Frame: Baseline, 6 months, 12 months
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
Time Frame: Baseline, 6 months, 12 months
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
Time Frame: Baseline
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
Time Frame: Baseline if required per clinician assessment
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
Time Frame: From enrolment until the end of intervention at 12 months
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
Time Frame: From enrolment until drop-out, withdrawal, or end of intervention at 12 months
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
Time Frame: From enrolment until end of intervention at 12 months
Obesity-related medical comorbidities will be assessed
From enrolment until end of intervention at 12 months
Sub-group analyses - Social demographics
Time Frame: At enrolment
Participant social demographics such as sex, ethnicity, age, and Index of Multiple Deprivation (IMD) will be assessed.
At enrolment
Clinical measures - height
Time Frame: Baseline
Height in metres will be assessed as part of the clinical measures analysis
Baseline
Clinical measures - blood pressure
Time Frame: Baseline, 6 months, and 12 months
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
Time Frame: Baseline, 6 months, and 12 months
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
Time Frame: Baseline, 6 months, 12 months
Self-reported waist circumference in centimetres will assessed as part of the clinical measures analysis
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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