Adherence to a Personalised Nutrition ProgrammeNCT07407556
Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support
A study testing Psychology-tailored message and Neutral message in people with Adherence to a Personalised Nutrition Programme, run by Alexandra King at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Adherence to a Personalised Nutrition Programme
- What is being tested?
- Psychology-tailored message and Neutral message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St Mary's University
Twickenham, Middlesex, TW1 4SX
About this study
Official title: Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support: An n=1 Randomised Trial
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.
- Being tested
- Psychology-tailored message, Neutral message
- Keywords
- personalised nutrition, behaviour change, adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychology-tailored messageBehavioural
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 messageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Static personalisation | Active comparator | 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. Receives: Behavioral: Neutral message |
| Fully personalised | Experimental | 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) Receives: Behavioral: Psychology-tailored message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
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.
Measured: From enrolment to the end of the 6 week intervention
Secondary outcomes (1)
Participant experiences from post-intervention focus group
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.
Measured: Within 4 weeks following completion of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start13 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to a Personalised Nutrition ProgrammeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a 6-week n-of-1 micro-randomised trial (MRT) across multiple participants designed to evaluate the effect of message tailoring (psychology-tailored vs neutral) on short-term habit adherence within a fully personalised lifestyle intervention. An MRT is a within-person experimental design in which each participant is repeatedly randomised to different intervention conditions. This allows estimation of causal, moment-level effects even in small samples because each participant serves as their own control.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandra King
- Sponsor type
- University, hospital or other
- Collaborators
- Optimyse Nutrition LTD
- Responsible party
- Sponsor-investigator, Alexandra King, St. Mary's University, Twickenham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407556
- Sponsor's protocol ID
- SMU_ETHICS_2025-26_195
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The findings will be used to develop a commercial App for dietary behaviour change
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support: An n=1 Randomised Trial
- ClinicalTrials.gov ID
- NCT07407556
- Acronym / sponsor ID
- SMU_ETHICS_2025-26_195
- Keywords
- personalised nutrition, behaviour change, adherence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alexandra KingUniversity, hospital or other
- Collaborators
- Optimyse Nutrition LTD
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a 6-week n-of-1 micro-randomised trial (MRT) across multiple participants designed to evaluate the effect of message tailoring (psychology-tailored vs neutral) on short-term habit adherence within a fully personalised lifestyle intervention. An MRT is a within-person experimental design in which each participant is repeatedly randomised to different intervention conditions. This allows estimation of causal, moment-level effects even in small samples because each participant serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Static personalisation | Active comparator | Behavioral: Neutral messageAll 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. |
| Fully personalised | Experimental | Behavioral: Psychology-tailored messageAll 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants must:
- 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.
Key exclusion criteria (12 listed)
- Participants will be excluded if they:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychology-tailored messageParticipants 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. | Behavioural | Fully personalised |
| Neutral messageParticipants 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. | Behavioural | Static personalisation |
Primary outcome
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.
1 secondary outcome
Participant experiences from post-intervention focus group
Time frame: Within 4 weeks following completion of intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided. The findings will be used to develop a commercial App for dietary behaviour change
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychology-tailored message and Neutral message in people with Adherence to a Personalised Nutrition Programme, run by Alexandra King at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: From enrolment to the end of the 6 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.