NCT07283978尚未招募不适用
Real-world Exploration of Digital iNnovation in the Management of Excess Weight
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 580
- 试验地点
- 2
- 主要终点
- Percentage of weight change at 12 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of weight change at 12 months
时间窗: Baseline and 12 months
Quality of Life as a measure to determine cost-effectiveness
时间窗: Baseline and 12 months
Quality of Life will be measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire
次要结局
- Patient reported outcomes - eating pattern(Baseline, 6 months, 12 months)
- Feasibility of implementing the intervention into Tier 3 weight management pathways(Once)
- Acceptability of implementing the intervention into Tier 3 weight management pathways(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(From enrolment until the end of the intervention at 12 months)
- Economic measurements - Quality of Life Years(Baseline, 6 months, and 12 months)
- Economics measurements - Resource Use(From enrolment to the end of the intervention at 12 months)
- Economics measurements - Unit costs(From enrolment to end of intervention at 12 months)
- Economics measurements - Costs between intervention group and standard care group(From enrolment to end of intervention at 12 months)
- Patient reported outcomes - alcohol use(At Baseline, 6 months, and 12 months)
- Patient reported outcomes - patient health(Baseline, 6 months, 12 months)
- Patient reported outcomes - binge eating(Baseline)
- Patient reported outcomes - physical activity(Baseline if required per clinician assessment)
- Sub-group analyses- Use of glucagon-like peptide (GLP-1) agonists(From enrolment until the end of intervention at 12 months)
- Sub-group analyses - Adherence(From enrolment until drop-out, withdrawal, or end of intervention at 12 months)
- Sub-group analyses - Comorbidities(From enrolment until end of intervention at 12 months)
- Sub-group analyses - Social demographics(At enrolment)
- Clinical measures - height(Baseline)
- Clinical measures - blood pressure(Baseline, 6 months, and 12 months)
- Clinical measures - Body Mass Index(Baseline, 6 months, and 12 months)
- Clinical Measures - waist circumference(Baseline, 6 months, 12 months)
研究者
研究点 (2)
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