Metabolic Syndrome, Obesity
Conditions
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.
Detailed description
This is same as above.
Interventions
OTHERmobile health lifestyle intervention
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.
Sponsors
Aga Khan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight in kilograms, height in meter (will be combined to report BMI in kg/m^2) | one year | A weighing scale will be used for this and values recorded on a questionnaire |
| Advance glycation end product (U/mL) from serum | one year | 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. |
| Body fat percentage | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Methylation level of genes | 1 year | From the blood samples collected, DNA will be used to measure the methylation level of genes of interest such as Leptin, POMC, desnutrin etc. These molecular biology testing of this physiological parameter will be conducted in the laboratory and results will be recorded on a questionnaire. |
| Meal quality and calorie count | 1 year | Participants will be asked to make a meal diary and write all their food intake and physical activity on a mobile app. They will share their monthly progress with the investigator via WhatsApp (m-health) . |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORSadia Fatima, PhD
Aga Khan University
Outcome results
None listed