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

Aga Khan University

Status: Completed

Conditions: Obesity; Metabolic Syndrome

Treatments: Other: mobile health lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06448806

Mhealth-Epigen

Details and patient eligibility

About

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, at 6 months and 12 months. Keep a diary of their food and activity and the number of times they use mobile health application.

Full description

This is same as above.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Lifestyle modification through m-health

Other group

Description:

Individuals recruited will be followed for a year and offered lifestyle intervention

Treatment:

Other: mobile health lifestyle intervention