Mobile phone based (m-health) nutrition counselling and lifestyle modification intervention to reduce risk of heart disease

Not Applicable

Conditions: Cardiovascular Diseases and related risk conditions (Obesity, Hypertension, Dyslipidaemia, Diabetes Mellitus)

Registration Number: SLCTR/2016/018

Lead Sponsor: ational Research Council

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Male and female participants ages 35 to 64 years
2. Body Mass Index 25 kg per square meter or higher

Exclusion Criteria

1. History of any cardiovascular event (myocardial infarction; unstable angina or stable angina, past coronary artery procedure, stroke or Transient Ischaemic Attacks)
2. Renal artery or kidney disease
3. Peripheral vascular disease
4. Congestive heart failure
5. Cancer or treatment for cancer in the last 2 years;
6. Pregnancy and lactation.

Not having a mobile phone for personal use will not be a reason for exclusion as the study will provide a mobile phone with connection for those who do not possess a mobile phone.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Body mass index<br>2. Blood pressure<br>3. Fasting Blood glucose<br>4. Serum cholesterol and lipid profile<br>5. Smoking status<br>6. Estimated 10-year cardio vascular risk (calculated using both WHO/ISH risk prediction charts and Framingham risk equation)<br> [At baseline and at 9 months after commencement of the intervention]<br>

Secondary Outcome Measures

Name	Time	Method
1. Body composition analysis - bio impedance assessment method using Body Composition Analyzer ( model HBF 375)<br>2. Dietary intake - QUT & DRU Food Frequency Questionnaire validated for Sri Lanka<br>3. Physical activity – IPAQ (international Physical Activity Questionnaire) validated for Sri Lanka<br>4. Alcohol use – Same set of questions as in the WHO STEPS survey<br> [At baseline and at 9 months after commencement of the intervention]<br>