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

July 16, 2026 updated by: Alexandra King

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Middlesex
      • Twickenham, Middlesex, United Kingdom, TW1 4SX
        • St Mary's University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants must:

    1. Be 18-45 years old.
    2. Have a BMI between 18.5 and 40 kg/m² (normal weight to obesity categories).
    3. Own a smartphone with WhatsApp installed.
    4. Be willing to receive daily messages for 6 weeks.
    5. Be able to provide informed consent.
    6. Be willing to provide a cheek swab for DNA analysis.
    7. 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:

    1. Have a diagnosed eating disorder or significant disordered eating symptoms.
    2. Are currently pregnant or breastfeeding.
    3. Have any medical condition requiring medically supervised dietary modification (e.g., diabetes requiring medication, kidney disease, coeliac disease).
    4. Are currently taking medication that significantly affects appetite, weight, or metabolism (e.g., GLP-1 agonists).
    5. Work night shifts
    6. Have severe mental health conditions (e.g., moderate-severe depression, psychosis).
    7. Are participating in another behaviour-change or weight-related study.
    8. Are unwilling to receive WhatsApp messages
    9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: Neutral message

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.
Experimental: 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)
Behavioral: Psychology-tailored message

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrolment to the end of the 6 week intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 4 weeks following completion of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandra King

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Optimyse Nutrition LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMU_ETHICS_2025-26_195

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The findings will be used to develop a commercial App for dietary behaviour change

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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