Active, Not Recruiting

NCT Number: NCT07407556

Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Adherence to a Personalised Nutrition Programme

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's University

Twickenham, Middlesex, TW1 4SX, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Psychology-tailored message

Behavioral

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)

Daily personalisation influences:

difficulty level of the daily goal
specific behaviour change technique (BCT) chosen (e.g., action planning vs implementation intention vs coping planning)
tone, structure and timing of the message
reinforcement style The nutrition content remains identical; only HOW it is delivered changes.

Neutral message

Behavioral

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.

Primary outcomes

Adherence

Time frame: 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.

Secondary outcomes

Participant experiences from post-intervention focus group

Time frame: Within 4 weeks following completion of intervention.

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.

Sponsors and collaborators

Lead sponsor

Alexandra King

Other

Collaborators

Optimyse Nutrition LTD

Registry information

Official study title

Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support: An n=1 Randomised Trial

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 12, 2026
Registry last updated: Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.