Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support: An n=1 Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
Personalised nutrition approaches typically rely on static information such as health status, lifestyle and genetic data. However, adherence often remains low because daily behaviours are influenced by psychological states, motivation and real-time barriers. There is growing interest in whether integrating behavioural signals and timely prompts could strengthen engagement. The purpose of this study is to explore whether incorporating psychological adaptation and just-in-time behavioural prompts leads to better adherence to a personalised nutrition programme compared with commonly used personalised approach (combining health, lifestyle and genetics data without psycho-behavioural adaptation). Using a six-week n-of-1 randomised trial design implemented across multiple participants, the research will also assess the feasibility of delivering this adaptive support in a free-living environment, as well as participants' engagement, acceptability and perceived usefulness. Following completion of the 6-week intervention, an optional focus group will be conducted with a subset of participants (maximum 8) within four weeks of the final study day. The focus group will last approximately 60-90 minutes and will be conducted in person or via video call. Qualitative data from the focus group will be analysed using reflexive thematic analysis (Braun & Clarke, 2021). These findings will inform the development of an adaptive personalised nutrition AI agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must:
- •Be 18-45 years old.
- •Have a BMI between 18.5 and 40 kg/m² (normal weight to obesity categories).
- •Own a smartphone with WhatsApp installed.
- •Be willing to receive daily messages for 6 weeks.
- •Be able to provide informed consent.
- •Be willing to provide a cheek swab for DNA analysis.
- •Have sufficient English proficiency to understand daily written instructions.
- •Given that the programme focuses on the six pillars of lifestyle medicine (nutrition, physical activity, sleep, stress management, social connection, and alcohol/substance moderation), participants must be able to safely engage with light lifestyle recommendations.
排除标准
- •Participants will be excluded if they:
- •Have a diagnosed eating disorder or significant disordered eating symptoms.
- •Are currently pregnant or breastfeeding.
- •Have any medical condition requiring medically supervised dietary modification (e.g., diabetes requiring medication, kidney disease, coeliac disease).
- •Are currently taking medication that significantly affects appetite, weight, or metabolism (e.g., GLP-1 agonists).
- •Work night shifts
- •Have severe mental health conditions (e.g., moderate-severe depression, psychosis).
- •Are participating in another behaviour-change or weight-related study.
- •Are unwilling to receive WhatsApp messages
- •Are unwilling to receive genetic information This will be checked with PARQ questionnaire
- •Focus group participants:
- •All 14 study participants will be invited to participate in the optional post-intervention focus group. As the focus group is limited to a maximum of 8 participants, if more than 8 express interest, selection will be made to ensure diversity across gender, age, engagement during the intervention and personality profile to maximise the richness of discussion. Participants who are not selected or who decline will not be disadvantaged in any way and their study data will be retained and analysed as normal.
研究组 & 干预措施
Static personalisation
All participants receive a fully personalised dietary and lifestyle plan based on:
- baseline lifestyle and diet
- health status
- environmental context
- genetic polymorphisms (e.g., FTO, APOA2, TCF7L2, CLOCK, TMPRSS6, FADS1/2, MTNR1B, CYP1A2, taste receptors) This ensures that both study arms receive personalised nutrition, reflecting current best practice.
Participants receive:
- One fixed daily behaviour goal, aligned with the weekly pillar
- Personalised only according to diet, lifestyle, health status and genetics
- Delivered at a pre-selected time chosen by the participant (e.g., 8:30-10:00)
No adaptation is made based on:
- psychological traits
- daily mood/energy
- anticipated or reported barriers
- communication preferences (tone, length, mode) This reflects current "gold standard" personalised nutrition: personalised by biology and lifestyle, but not by psychology or dynamic states.
干预措施: Neutral message (Behavioral)
Fully personalised
All participants receive a fully personalised dietary and lifestyle plan based on:
- baseline lifestyle and diet
- health status
- environmental context
- genetic polymorphisms (e.g., FTO, APOA2, TCF7L2, CLOCK, TMPRSS6, FADS1/2, MTNR1B, CYP1A2, taste receptors) This ensures that both study arms receive personalised nutrition, reflecting current best practice.
Participants receive the same nutritional and lifestyle content, but daily goals are adapted based on:
Stable Traits
- Big Five personality
- Health locus of control
- Optimism bias
- Delay discounting
- Self-determination
- Stress/anxiety baseline
- Habit awareness
- Values/motivations
- Reward preferences Daily State
- Morning energy rating (1-5)
- Expected barriers
- Context (home vs office vs weekend) Communication Preferences
- tone (coachy, compassionate, factual, brief)
- message length (low/medium/high)
- mode (text, voice, image) Environmental and Social Context (e.g., Friday office snacks, partner-driven late dinners)
干预措施: Psychology-tailored message (Behavioral)
结局指标
主要结局
Adherence
时间窗: From enrolment to the end of the 6 week intervention
Adherence is defined as daily completion or active attempt of the assigned lifestyle goal. Adherence is measured using a brief daily self-report item delivered via WhatsApp as part of an ecological momentary assessment. Each day, participants are asked whether they completed or actively attempted the assigned goal (Yes/No). Daily adherence is coded as a binary outcome (1 = completed, 0 = not completed). Adherence rates are calculated as the proportion of completed goal days relative to total analysable person-days and compared between personalised intervention days and static control days. An analysable person-day is defined as a day on which a goal message was successfully delivered and a corresponding adherence response was received within the response window. Days with missing responses or delivery failures are excluded from adherence analyses.
次要结局
- Participant experiences from post-intervention focus group(Within 4 weeks following completion of intervention.)
研究者
Alexandra King
Head of School Allied Health and Life Sciences
St. Mary's University, Twickenham