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OpenTrials
Enrolling by Invitation

NCT Number: NCT07283978

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guy' & St Thomas' NHS Foundation Trust

London, Greater London, SE1 9RT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Weight Management Programme

Other

Digital Weight Management Programme

Primary outcomes

  1. Percentage of weight change at 12 months

    Time frame: Baseline and 12 months

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Uptake of the intervention

    Time frame: 12 months

  4. Retention in the intervention programme

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

  5. 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.

  6. 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)

  7. 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)

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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

  17. Sub-group analyses - Comorbidities

    Time frame: From enrolment until end of intervention at 12 months

    Obesity-related medical comorbidities will be assessed

  18. 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.

  19. Clinical measures - height

    Time frame: Baseline

    Height in metres will be assessed as part of the clinical measures analysis

  20. 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

  21. 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.

  22. 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

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Acronym: RENEW

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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