CompletedNot Applicable

Mobile Health (M-health) Intervention to Reduce the Epigenetic Signature in Metabolic Syndrome (MetS)

Pakistan26 participantsStarted 2024-06-24

Plain-language summary

The goal of this interventional study is to learn about the improvement in body composition effects of lifestyle intervention in subjects with metabolic syndrome. The main question it aims to answer is: Does life style intervention lower body fat% and gene methylation levels in subjects with metabolic syndrome? Participants will answer survey questions and get blood and body composition testing done at day 0, and 12 months. Keep a diary of their food and activity and the number of times they use mobile health application.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Less than 5 kg body weight fluctuation in the 6 months prior to recruitment.
. 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).
. 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)".
. Have access to a smart phone/mobile and not using the fitness application

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Weight in kilograms, height in meter (will be combined to report BMI in kg/m^2)

Timeframe: one year

Advance glycation end product (U/mL) from serum

Timeframe: one year

Body fat percentage

Timeframe: 1 year

Trial details

NCT IDNCT06448806

SponsorAga Khan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-24

View on ClinicalTrials.gov More Metabolic Syndrome trials