Application of a Precision Lifestyle Medicine Clinical Program for a Sample of IFHAS Screening Cohort
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in Body Mass Index (BMI)
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate whether a precision lifestyle medicine intervention can improve cardiometabolic health in Emirati adults aged 25 to 50 years living in Abu Dhabi with obesity (BMI 30-35 kg/m²) who have previously completed IFHAS screening. The study will also use IFHAS screening data to better understand participants' health profiles and the relationship between lifestyle factors and chronic diseases. The main questions it aims to answer are:
- Does a precision lifestyle medicine program improve cardiometabolic biomarkers after an 18-week intervention?
- Can IFHAS screening data be used to identify health risk profiles and support personalized lifestyle interventions for the Emirati population?
Researchers will compare participants receiving the precision lifestyle medicine intervention with a propensity-matched control group receiving standard IFHAS care to determine whether the intervention leads to greater improvements in cardiometabolic health.
Participants will:
- Take part in an 18-week personalized lifestyle medicine program tailored to their health profile.
- Attend study visits and complete health assessments over a total study period of 24 weeks.
- Undergo cardiometabolic biomarker assessments before and after the intervention.
- Complete questionnaires or assessments about their adherence to the lifestyle program and their experience with the precision lifestyle medicine clinic.
- Provide biological samples to support the establishment of a biomarker repository for future research.
Detailed Description
This study is a prospective clinical trial designed to evaluate the effectiveness of a precision lifestyle medicine program in improving cardiometabolic health among Emirati adults with obesity. The study also aims to use data collected through the IFHAS screening program to better understand the current health status, disease risk profiles (pathophenotypes), and associations between lifestyle factors and chronic diseases within the Emirati population.
A total of 150 eligible participants will be enrolled to receive an individualized precision lifestyle medicine intervention. Their outcomes will be compared with those of 150 propensity score-matched individuals selected from the IFHAS database who receive standard IFHAS care. The intervention is designed to provide personalized lifestyle recommendations based on each participant's clinical characteristics and health profile.
Eligible participants are Emirati adults aged 25 to 50 years who reside in the Emirate of Abu Dhabi, have a body mass index (BMI) between 30 and 35 kg/m², are Thiqa cardholders, have completed at least one IFHAS screening, are enrolled in the Emirati Genome Programme, and are able to provide informed consent. Individuals receiving weight-loss medications, those with certain medical conditions or physical limitations that may interfere with participation, pregnant women, and individuals enrolled in other lifestyle intervention programs are excluded.
Recruitment will occur on a rolling basis until the target sample size of 150 participants is reached. Each participant will be involved in the study for approximately 24 weeks, including an 18-week precision lifestyle medicine intervention and follow-up assessments.
The primary objectives of the study are to:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Emiratis residing in Abu Dhabi emirate
- •Aged 25-50 years
- •BMI 30-35 kg/m²
- •Thiqa cardholder
- •Previous participation in IFHAS screening
- •Able to provide informed consent
- •Participant in the Emirati Genome Programme
- •No weight-loss medications (e.g., Ozempic, Saxenda, Wegovy) within 3 months of enrollment.
Exclusion Criteria
- •Aged under 25 years or over 50 years of age
- •BMI range under 30 kg/m2 and over 35 kg/m2
- •Taking weight loss medication such as GLP-1 drugs (Ozempic, Saxenda, Wegovy)
- •Active treatment for serious medical conditions (cancer, planned surgery, immunomodulation)
- •Transplant surgery within 12 months
- •Pregnancy
- •Surgery within 3 months prior to recruitment
- •Physical limitations preventing exercise participation
- •Current enrolment in other lifestyle intervention programs
- •Active psychiatric conditions, cognitive impairment, or mental health conditions affecting study participation
- •Contraindication to MRI or DEXA imaging, including severe claustrophobia or need for sedation.
Outcomes
Primary Outcomes
Change in Body Mass Index (BMI)
Time Frame: Baseline and Week 24
Mean change in body mass index (BMI) from baseline to Week 24 following the precision lifestyle medicine intervention.
Change in Cardiometabolic Composite Response
Time Frame: 24 weeks
Proportion of participants classified as cardiometabolic responders at Week 24, defined as achieving at least two of the following: ≥3% reduction in body weight, ≥5% reduction in ApoB (or LDL-C), ≥0.3% reduction in HbA1c (or ≥15% reduction in HOMA-IR), ≥3 mmHg reduction in systolic blood pressure, or ≥2 cm reduction in waist circumference.
Secondary Outcomes
- High responder rate(24 weeks)
- Change in body weight(baseline to week 24)
- Change in HbA1c(Baseline to Week 24)
- Change in ApoB(Baseline to Week 24)
- VO₂peak(Baseline to Week 24)
- Change in 10-year cardiovascular disease risk(Baseline to Week 24)
- Change in 10-year type 2 diabetes risk(Baseline to Week 24)
- Participant commitment to the intervention(Throughout the intervention (up to Week 24))
- Participant experience(Week 24)