ObesityRENEWNCT07283978

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

A study testing Digital Weight Management Programme in people with Obesity and Obesity & Overweight, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity, Obesity & Overweight
What is being tested?: Digital Weight Management Programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 580 participants
Where: 1 siteUnited Kingdom
Study dates: 16 Dec 2025to Nov 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site

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

Other trials in United Kingdom

About this study

Conditions: Obesity, Obesity & Overweight
Being tested: Digital Weight Management Programme
Keywords: Weight Management, Digital Weight Management, Obesity
Medical subject headings: Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Digital Weight Management ProgrammeOther
Digital Weight Management Programme

Study groups in NCT07283978
Study group	Role	What they receive
Group A Intervention	Active comparator	Study participants who receive 12 months of digital weight management services delivered through a smartphone app. Receives: 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 Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of weight change at 12 months
Measured: 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
Measured: Baseline and 12 months

Secondary outcomes (22)

Feasibility of implementing the intervention into Tier 3 weight management pathways
This will be assessed through qualitative interviews with participants in the Sub-study.
Measured: 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.
Measured: Once
Uptake of the intervention
Measured: 12 months
Retention in the intervention programme
Measured: 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.
Measured: 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)
Measured: Baseline, 6 months, and 12 months
Economics measurements - Resource Use
Resource use covering primary and secondary care services within the National Health Service (NHS)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: From enrolment until the end of intervention at 12 months
Sub-group analyses - Adherence
Participant adherence to the intervention will be assessed
Measured: From enrolment until drop-out, withdrawal, or end of intervention at 12 months
Sub-group analyses - Comorbidities
Obesity-related medical comorbidities will be assessed
Measured: 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.
Measured: At enrolment
Clinical measures - height
Height in metres will be assessed as part of the clinical measures analysis
Measured: Baseline
Clinical measures - blood pressure
Self-reported blood pressure will be assessed as part of the clinical measures analysis
Measured: 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.
Measured: 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
Measured: Baseline, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 2025Nov 2027

First posted16 Dec 2025
Study start16 Dec 2025
Primary completionNov 2027 (estimated)
Study completionNov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 580 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07283978
Sponsor's protocol ID: 351778
Acronym: RENEW
Status last verified: Oct 2026
First submitted: 19 Nov 2025
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD will be shared on reasonable request.

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Active, not recruiting
tDCS With Cognitive Training to Reduce Impulsivity and Weight in Veterans With Obesity
Obesity
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity

All Obesity trials