- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415109
Improving LDL-C Levels Through Temporal Self-regulation Theory-based, Personality-tailored Health Messages
Improving LDL-C Levels Through Temporal Self-regulation Theory-based, Personality-tailored Health Messages: A Three-Arm Randomized Controlled Trial
The study is meant to run parallel to the larger study, RESET. The goal of this study is to to evaluate the effectiveness of a once-off general and personality-tailored text message on GP consultation among RESET participants identified to have high LDL-C. The main question it aims to answer is:
Will participants exposed to personality tailored advice have a higher adherence to GP consultation compared to the participants in the control group?
Researchers will compare a personalized message to a general message (with no personalization according to patients personality type) and control group to see if the messages increase adherence.
Participants are required to complete two questionnaires: one before and one after they receive their RESET results.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jocelyn Chew
- Phone Number: +6565168687
- Email: dbi-lab@nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 117599
- Recruiting
- National University of Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- New participants of RESET who have given consent to be contacted for future studies
- ≥21 years old
Exclusion Criteria:
- are not able to read, write or communicate in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Personality-Tailored Message
|
The intervention will consist of messages and infographics embedded in participants' return of results (ROR) emails within the RESET study. Each participant will receive the ROR alongside the intervention once, at the time their results are sent. No repeat messages will be delivered. The message will include the personality-tailored message with the same core content as the general message, including indications for lipid therapy, benefits of lipid-lowering medications, common side effects, risks of non-adherence, and an infographic on diet and lifestyle modification based on ACE lipid management guidance. An infographic will be included in the same ROR email. This message will contain an added component framed according to conscientiousness and neuroticism scores, as these traits are strong predictors of health behaviours. Scores will be derived from baseline BFI-44 results. |
|
Active Comparator: General Message
|
The intervention will consist of messages and infographics embedded in participants' return of results (ROR) emails within the RESET study. Each participant will receive the ROR alongside the intervention once, at the time their results are sent. No repeat messages will be delivered. The general health message will include indications for lipid therapy, benefits of lipid-lowering medications, common side effects, risks of non-adherence, and an infographic on diet and lifestyle modification based on ACE lipid management guidance. The infographic will be included in the same ROR email. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intention to adopt a healthier diet
Time Frame: From enrollment to 3 months after results have been returned.
|
A 3-item, 7-point Likert scale assessing participants' intention to adopt a healthier diet.
The minimum and maximum score one can attain on this measure is 3 and 21 respectively, with a higher score indicating higher intention to adopt a healthier diet.
|
From enrollment to 3 months after results have been returned.
|
|
Intention to engage in Physical Activity
Time Frame: From enrollment to 3 months after results have been returned.
|
A 3-item, 7-point Likert scale assessing participants' intention to engage in physical activity.
The minimum and maximum score one can attain on this measure is 3 and 21 respectively, with a higher score indicating higher intention to engage in physical activity.
|
From enrollment to 3 months after results have been returned.
|
|
Intention to visit a General Practitioner
Time Frame: 3 months after results have been returned.
|
A 3-item, 7-point Likert scale assessing participants' intention to visit a general practitioner.
The minimum and maximum score one can attain on this measure is 3 and 21 respectively, with a higher score indicating higher intention to visit a general practitioner.
|
3 months after results have been returned.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Big Five Inventory - 44
Time Frame: From enrollment
|
A 44-item, 5-point Likert scale questionnaire that assesses the "Big Five" personality traits of a participant: namely Openness, Conscientiousness, Extraversion, Agreeableness, and Neuroticism, each represented as sub-scales. Subscale scores are calculated by summing the relevant items. The minimum / maximum score for each sub-scale is as follows, with higher scores indicating higher representation of the respective personality trait. Openness: 10/50 Conscientiousness: 9/45 Extraversion: 8/40 Agreeableness: 9/45 Neuroticism: 8/40 |
From enrollment
|
Collaborators and Investigators
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
- NUS-IRB-2025-334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Adherence
-
Universiti Putra MalaysiaCompletedMedication Adherence | Adherence, TreatmentPakistan
-
University of GiessenKruse Johannes; Florian Blachutzik; Andreas RiethNot yet recruitingHeart Failure | Adherence, Medication | Adherence, Treatment
-
Universidad Rey Juan CarlosUnknownCardiovascular Diseases | Physical Disability | Treatment Adherence | Satisfaction | Adherence, PatientSpain
-
CNGE ConseilCompleted
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingAdherence, Medication | Adherence, Patient | Transplant; Failure, Liver | Adherence, Treatment | Transplant;Failure,KidneyUnited States
-
University of MiamiNot yet recruiting
-
Swiss Tropical & Public Health InstituteNot yet recruiting
-
Children's Hospital Medical Center, CincinnatiSeattle Children's Hospital; St. Jude Children's Research Hospital; University...CompletedCancer | Adherence, MedicationUnited States
-
Afyonkarahisar Health Sciences UniversityNot yet recruitingHandwashing Behavior
-
University of California, San FranciscoNot yet recruitingBreast SurgeryUnited States
Clinical Trials on Personalized Message
-
Indiana UniversityPatient-Centered Outcomes Research InstituteCompletedCancer Screening TestsUnited States
-
Emory UniversityCompleted
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of Colorado, DenverNational Cancer Institute (NCI); Massachusetts General Hospital; Dana-Farber... and other collaboratorsNot yet recruitingColorectal CancerUnited States
-
Wills EyeCompleted
-
Mayo ClinicAdelante HealthcareCompleted
-
Children's Hospital Medical Center, CincinnatiCompletedEffect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChartHealth Care UtilizationUnited States
-
University of North Carolina, Chapel HillWellcome TrustCompletedHeart Diseases | Obesity | CancerUnited States
-
Imperial College LondonNHS EnglandCompleted