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| Name | Class |
|---|---|
| King's College London | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Intervention | Active Comparator | Study participants who receive 12 months of digital weight management services delivered through a smartphone app. |
|
| Group B Intervention | Active Comparator | Study participants who receive 12 months of digital weight management services delivered through a smartphone app |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Weight Management Programme | Other | Digital Weight Management Programme |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Walker, PhD | Guy's and St Thomas' NHS Foundation Trust | Study Chair |
| Emma Duncan, MD, PhD | King's College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy' & St Thomas' NHS Foundation Trust | London | Greater London | SE1 9RT | United Kingdom |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
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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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |