The LvL UP Trial: a Sequential, Multiple Assignment, Randomized Controlled 2 Trial to Assess the Effectiveness of a Blended Mobile Lifestyle Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,073
- 试验地点
- 4
- 主要终点
- Mental well-being (Warwick-Edinburgh Mental Well-being Scale)
研究概览
简要总结
Non-communicable diseases (NCDs), such as cardiovascular disease, diabetes, or cancer, and common mental disorders (CMDs), such as depression or anxiety, represent the primary causes of death and disability worldwide, causing major health and financial burdens. Lifestyle behaviours, including physical activity, diet, stress and emotional regulation, tobacco smoking, alcohol consumption, and sleep are important modifiable risk factors associated with the prevention and management of both NCDs and CMDs.
LvL UP is a mHealth intervention aimed at preventing NCDs and CMDs in adults from multi-ethnic Southeast Asian populations. Building upon leading evidence- and theory-based frameworks in the areas of mental health and behaviour change, a multidisciplinary team of researchers developed LvL UP as a holistic intervention centred around three core pillars: Move More, Eat Well, Stress Less.
This study is aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP, an mHealth lifestyle intervention for the prevention of NCDs and CMDs, and (ii) establishing the optimal blended approach in LvL UP that balances effective personalized lifestyle support with scalability.
详细描述
Participants will:
- Visit the study site at baseline and month 6 to complete assessments.
- Complete online assessments at months 1, 3, 9 and 12.
- Be assigned to group 1 (intervention) or group 2 (comparison).
- Participants in group 1 will download the LvL UP App.
- Participants in group 1 categorized as non-responders; at month 1 will start receiving six motivational interviewing coaching sessions in addition to continue using the LvL UP app (LvL UP + MI).
- Participants in group 2 will receive a package with standard lifestyle resources from Singapore Health Promotion Board.
Participants will be randomly allocated to groups 1 or 2 (LvL UP or comparison) following a 2:1 ratio favoring the LvL UP group. At month 1 (decision point), participants from the LvL UP group will be classified as responders or non-responders based on pre-specified criteria. Non-responder participants will be re-randomized with equal probability (1:1) to one of the two second-line conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional MI support sessions (LvL UP + MI). The LvL UP pilot study results (NCT06360029) will be used to inform the tailoring variable(s) for the trial (i.e., to define response / non-response at month 1). Engagement and app evaluation variables (e.g., number of app components completed over the first 4 weeks, net promoter score), preliminary intervention effects (e.g., initial positive response), or a combination of the two will be used.
Participants will also take part in a process evaluation informed by the UK Medical Research Council guidelines to explore implementation (process, fidelity, dose, adaptations, reach), mechanisms of action (participant experience and response to intervention, mediators, unexpected pathways and consequences), and contextual factors that may affect implementation and intervention outcomes. Methods will entail qualitative and quantitative approaches, including surveys, interviews, web-based and app-based analytic data, and direct observation. In addition, other measures have been added to the research protocol to address the following exploratory aims (all relevant measures are described in the outcomes section):
A. To identify the most cost-effective intervention condition from the societal perspective (e.g., self-reported sickness absence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) aged 21 to 59 years,
- •(ii) Singapore citizens, permanent residents, or foreigners residing in Singapore on long-term passes with at least 1 year of validity remaining,
- •(iii) planning to reside in Singapore for the duration of the study (eligible participants can undertake sporadic trips overseas, as long as these do not conflict with in-person study visits),
- •(iv) proficient in English (the LvL UP app is currently only available in English),
- •(v) owners of a smartphone (minimum requirements: iOS version 12.4 and Android version 8) with internet access,
- •(vi) able to provide informed consent, and
- •(vii) identified as 'at risk' of developing non-communicable diseases and/or common mental disorders.
排除标准
- •(i) diagnosed with one of the following chronic diseases: heart disease (e.g., heart attack and stroke), cancer, chronic respiratory diseases (e.g., chronic obstructed pulmonary disease and asthma), diabetes (type 1 or type 2), or chronic kidney disease.
- •(ii) diagnosed with one of the following mental disorders: major depressive disorders (depression), bipolar, eating disorders, post-traumatic stress disorder (PTSD), anxiety disorders, severe personality disorder, substance use disorders, or other mental health conditions diagnosed by a mental health professional.
- •(iii) pregnant, (iv) currently taking medications prescribed for high blood pressure or high blood glucose.
- •(v) past or current LvL UP users, including participants from the LvL UP pilot trial (NCT06360029) or HAPPY trial (Harnessing Human Potential and Improving Health Span in Women and their Children Trial).
- •(vi) already participating or planning to participate in the LvL UP trial as a 'LvL UP Buddy'.
- •(vii) enrolled or planning to enroll in another lifestyle intervention research study before or during the study period.
结局指标
主要结局
Mental well-being (Warwick-Edinburgh Mental Well-being Scale)
时间窗: Baseline, month 1, month 3, month 6, month 9, month 12
Assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS-14). The total score ranges from 14 to 70, with higher values indicating higher mental well-being.
次要结局
- Subjective well-being (World Health Organization Well-Being Index)(Baseline, month 1, month 3, month 6, month 9, month 12)
- Mental health (depression - Patient Health Questionnaire-9)(Baseline, month 1, month 3, month 6, month 9, month 12)
- Mental health (stress - Kessler Psychological Distress Scale)(Baseline, month 1, month 3, month 6, month 9, month 12)
- Health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version)(Baseline, month 3, month 6, month 9, month 12)
- Health behaviours (physical activity - International Physical Activity Questionnaire)(Baseline, month 1, month 3, month 6, month 9, month 12)
- Health behaviours (steps - smartphone-based)(Throughout the study period (i.e., assessed every day during 12 months))
- Health behaviours (sleep - Pittsburgh Sleep Quality Index)(Baseline, month 6, month 12)
- Health behaviours (smoking and alcohol consumption - ad hoc questionnaire)(Baseline, month 6, month 12)
- Anthropometry (body weight)(Baseline, month 6)
- Anthropometry (body height)(Baseline, month 6)
- Anthropometry (waist circumference)(Baseline, month 6)
- Anthropometry (hip circumference)(Baseline, month 6)
- Anthropometry (body composition)(Baseline, month 6)
- Anthropometry (self-reported height and weight)(month 1, month 3, month 9, month 12)
- Resting blood pressure(Baseline, month 6)
- Health behaviours (diet quality 1 - diet screener)(Baseline, month 1, month 3, month 6, month 9, month 12)
- Health behaviours (diet quality 2 - ad hoc Food Frequency Questionnaire)(Baseline, month 1, month 3, month 6, month 9, month 12)
- Blood metabolic profile (concentration of albumin, creatinine, DHEA-S, HbA1c, hsCRP, TC, HDL, TG, LDL-calculated, random glucose, and full blood count)(Baseline, month 6)
- Blood metabolic profile (food intake and health status)(Baseline, month 6)
- Self-reported health status(Baseline, month 3, month 6, month 9, month 12)
- Change in health status(Baseline, month 3, month 6, month 9, month 12)