Real-world Exploration of Digital iNnovation in the Management of Excess Weight
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Weight Management Programme.
- Who it may be relevant to
- Registry conditions: Obesity, Obesity & Overweight. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Other Digital Weight Management Programme
Digital Weight Management Programme
Primary outcome measures
- Percentage of weight change at 12 months [Time frame: Baseline and 12 months]
- Quality of Life as a measure to determine cost-effectiveness [Time frame: Baseline and 12 months]
Secondary outcome measures (12)
- Feasibility of implementing the intervention into Tier 3 weight management pathways [Time frame: Once]
- Acceptability of implementing the intervention into Tier 3 weight management pathways [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 [Time frame: From enrolment until the end of the intervention at 12 months]
- Economic measurements - Quality of Life Years [Time frame: Baseline, 6 months, and 12 months]
- Economics measurements - Resource Use [Time frame: From enrolment to the end of the intervention at 12 months]
- Economics measurements - Unit costs [Time frame: From enrolment to end of intervention at 12 months]
- Economics measurements - Costs between intervention group and standard care group [Time frame: From enrolment to end of intervention at 12 months]
- Patient reported outcomes - alcohol use [Time frame: At Baseline, 6 months, and 12 months]
- Patient reported outcomes - patient health [Time frame: Baseline, 6 months, 12 months]
- Patient reported outcomes - eating pattern [Time frame: Baseline, 6 months, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United Kingdom · 1 center
- Guy' & St Thomas' NHS Foundation Trust — London
Identifiers
NCT: NCT07283978 · 351778