- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07407556
Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support
Exploring the Use of Genetic and Behavioural Data in Tailoring Dietary and Lifestyle Support: An n=1 Randomised Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Middlesex
-
Twickenham, Middlesex, United Kingdom, TW1 4SX
- St Mary's University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Static personalisation
All participants receive a fully personalised dietary and lifestyle plan based on:
Participants receive:
No adaptation is made based on:
|
Participants receive:
No adaptation is made based on:
|
|
Experimental: Fully personalised
All participants receive a fully personalised dietary and lifestyle plan based on:
Participants receive the same nutritional and lifestyle content, but daily goals are adapted based on: Stable Traits
|
Participants receive the same nutritional and lifestyle content, but daily goals are adapted based on: Stable Traits
Daily personalisation influences:
|
What is the study measuring?
Primary Outcome Measures
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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SMU_ETHICS_2025-26_195
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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