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

N/AEnrolling By InvitationNCT07283978

Guy's and St Thomas' NHS Foundation Trust580 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

580

Conditions

Obesity Obesity & Overweight

Interventions

Digital Weight Management ProgrammeOTHER

Digital Weight Management Programme

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Guy' & St Thomas' NHS Foundation Trust

London, Greater London, United Kingdom

Outcomes

Primary Outcomes

Percentage of weight change at 12 months

Time frame: 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

Time frame: Baseline and 12 months

Secondary Outcomes

Feasibility of implementing the intervention into Tier 3 weight management pathways

This will be assessed through qualitative interviews with participants in the Sub-study.

Time frame: 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.

Time frame: Once

Uptake of the intervention

Time frame: 12 months

Retention in the intervention programme

Time frame: 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.

Time frame: 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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Baseline, 6 months, and 12 months

Economics measurements - Resource Use

Resource use covering primary and secondary care services within the National Health Service (NHS)

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

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

Sub-group analyses - Adherence

Participant adherence to the intervention will be assessed

Time frame: From enrolment until drop-out, withdrawal, or end of intervention at 12 months

Sub-group analyses - Comorbidities

Obesity-related medical comorbidities will be assessed

Time frame: 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.

Time frame: At enrolment

Clinical measures - height

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

Time frame: Baseline

Clinical measures - blood pressure

Self-reported blood pressure will be assessed as part of the clinical measures analysis

Time frame: 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.

Time frame: 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

Time frame: Baseline, 6 months, 12 months