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

NCT06448806 | Completed

• 1 other identifier: Mhealth-Epigen
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Obesity

Outcome Measures

Primary Outcomes (3)

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

  A weighing scale will be used for this and values recorded on a questionnaire

  one year

• Advance glycation end product (U/mL) from serum

  This serum biomarker level will be assessed by Enzyme linked immunosorbent assay (ELISA) at the laboratory. Values will be recorded as Units per milliliter on a questionnaire.

  one year

• Body fat percentage

  Body composition will be measured by Bioelectrical impedance matching (BIA) and computerized topography (CT) scans. The reports will be shared with the participants and values will be recorded on a questionnaire.

  1 year

Secondary Outcomes (2)

• Methylation level of genes

  1 year

• Meal quality and calorie count

  1 year

Study Arms (1)

Lifestyle modification through m-health

OTHER

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

Other: mobile health lifestyle intervention

Interventions

mobile health lifestyle intervention OTHER

You will be asked to record all dietary and physical activity log for 12 months on an application. Mobile sms reminders will be sent to you on regular basis. At day 0, and 12 months you will be asked to provide 3 ml of blood for the methylation and advance glycation level testing and your weight and body fat percentage will be measured. During this period you will have to follow the lifestyle and diet chart provided to you by the researchers.

Lifestyle modification through m-health

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18 or above 65 year
• Pregnant women
• Individuals with other comorbidities such as cancers, hepatic and/or renal impairment, or on hormonal supplements and/or anti-inflammatory drugs etc.
• Unfit for blood testing or no smart phone available

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

DBBS

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sadia Fatima, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 7, 2024
• Study Start: June 24, 2024
• Primary Completion: June 24, 2024
• Study Completion: May 21, 2025
• Last Updated: March 4, 2026

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)