Mobile health intervention to improve body composition in metabolic syndrome
Epigenetic Signature of Advance Glycation End Products (AGE) and Skin Autofluorescence As a Risk Predictor in Metabolically Healthy and Unhealthy Obese Adults
NA · Aga Khan University · NCT06448806
This study is testing whether a mobile health program that helps people with metabolic syndrome change their lifestyle can reduce body fat and improve their health over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Aga Khan University (other) |
| Locations | 1 site (Karachi, Sind) |
| Trial ID | NCT06448806 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effects of a mobile health lifestyle intervention on body composition and epigenetic markers in individuals with metabolic syndrome. Participants will engage in lifestyle changes and track their food and activity using a mobile application, while undergoing blood and body composition assessments at the start, 6 months, and 12 months. The study seeks to determine if these interventions can reduce body fat percentage and gene methylation levels associated with metabolic syndrome.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with metabolic syndrome who have a stable body weight and meet specific BMI and health criteria.
Not a fit: Patients who are significantly overweight or have unstable body weight fluctuations may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to significant improvements in body composition and metabolic health for patients with metabolic syndrome.
How similar studies have performed: Other studies have shown promising results with lifestyle interventions in metabolic syndrome, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Less than 5 kg body weight fluctuation in the 6 months prior to recruitment. 2. Ideal body weight for height falling according to the South Asian Criteria as per WHO recommended i.e. Body Mass Index (BMI) of 18.5 to 22.9 kg/m2 (normal-weight) and above 23kg/m2 (overweight/ obese). 3. Any one of the following characteristics "according to the modified National Cholesterol Education Program (NCEP) ATPIII guidelines i) waist circumference ii) hyper triglyceridemia (triglycerides ≥150 mg/dl) or low High density lipoprotein (HDL) cholesterol (HDL cholesterol ≤40 mg/dl for men and ≤50 mg/dl for women iii) elevated blood pressure (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥85 mmHg or current use of antihypertensive drugs) iv) impaired fasting glucose (fasting plasma glucose ≥100mg/dl) v) waist circumference (90 cm in men and 80 cm in women)". 4. Have access to a smart phone/mobile and not using the fitness application Exclusion Criteria: 1. Age \<18 or above 65 year 2. Pregnant women 3. Individuals with other comorbidities such as cancers, hepatic and/or renal impairment, or on hormonal supplements and/or anti-inflammatory drugs etc. 4. Unfit for blood testing or no smart phone available
Where this trial is running
Karachi, Sind
- DBBS — Karachi, Sind, Pakistan (RECRUITING)
Study contacts
- Principal investigator: Sadia Fatima, PhD — Aga Khan University
- Study coordinator: Sadia Fatima, PhD
- Email: sadia.fatima@aku.edu
- Phone: +9234864147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metabolic Syndrome, Obesity