Obesity, Obesity & Overweight
Conditions
Keywords
Weight Management, Digital Weight Management, Obesity
Brief 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 experience, and health inequalities), for individuals living with obesity accessing National Health Service (NHS) Tier 3 weight-management services.
Interventions
OTHERDigital Weight Management Programme
Digital Weight Management Programme
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of weight change at 12 months | Baseline and 12 months | — |
| Quality of Life as a measure to determine cost-effectiveness | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of implementing the intervention into Tier 3 weight management pathways | Once | This will be assessed through qualitative interviews with participants in the Sub-study. |
| Acceptability of implementing the intervention into Tier 3 weight management pathways | Once | This will be assessed through qualitative interviews with participants in the Sub-study. |
| 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 | 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. |
| Economic measurements - Quality of Life Years | 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) |
| Economics measurements - Resource Use | 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) |
| Economics measurements - Unit costs | 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. |
| Economics measurements - Costs between intervention group and standard care group | From enrolment to end of intervention at 12 months | Costs between intervention group and standard care group with be compared |
| Patient reported outcomes - alcohol use | 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 |
| Patient reported outcomes - patient health | 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 |
| Patient reported outcomes - eating pattern | 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. |
| Patient reported outcomes - binge eating | 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 |
| Patient reported outcomes - physical activity | 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 |
| Sub-group analyses- Use of glucagon-like peptide (GLP-1) agonists | 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 |
| Sub-group analyses - Adherence | From enrolment until drop-out, withdrawal, or end of intervention at 12 months | Participant adherence to the intervention will be assessed |
| Sub-group analyses - Comorbidities | From enrolment until end of intervention at 12 months | Obesity-related medical comorbidities will be assessed |
| Sub-group analyses - Social demographics | At enrolment | Participant social demographics such as sex, ethnicity, age, and Index of Multiple Deprivation (IMD) will be assessed. |
| Clinical measures - height | Baseline | Height in metres will be assessed as part of the clinical measures analysis |
| Clinical measures - blood pressure | Baseline, 6 months, and 12 months | Self-reported blood pressure will be assessed as part of the clinical measures analysis |
| Clinical measures - Body Mass Index | 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. |
| Clinical Measures - waist circumference | Baseline, 6 months, 12 months | Self-reported waist circumference in centimetres will assessed as part of the clinical measures analysis |
Countries
United Kingdom
Contacts
STUDY_CHAIRAndrew Walker, PhD
Guy's and St Thomas' NHS Foundation Trust
STUDY_DIRECTOREmma Duncan, MD, PhD
King's College London
Outcome results
None listed