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Effectiveness of a mobile phone based nutrition counselling and lifestyle modification intervention for reducing cardiovascular risks in adults in the community: A Randomized Controlled Trial -

SLCTR Registration Number

SLCTR/2016/018


Date of Registration

30 Jun 2016

The date of last modification

Jun 30, 2016



Application Summary


Scientific Title of Trial

Effectiveness of a mobile phone based nutrition counselling and lifestyle modification intervention for reducing cardiovascular risks in adults in the community: A Randomized Controlled Trial


Public Title of Trial

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


Disease of Health Condition(s) Studied

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


Scientific Acronym

M-HeNAL Trial


Public Acronym

M-HeNAL Trial


Brief title

M-Health Nutrition and Lifestyle Trial


Universal Trail Number

U1111-1182-9981


Any other number(s) assigned to the trial and issuing authority

National Research Council NRC 15-145; Ethics Review Committee Faculty of Medicine, University of Colombo - EC-16-061


Trial Details


What is the research question being addressed?

Can a m-health nutrition counselling and lifestyle modification intervention reduce cardiovascular risk by one-third when compared to usual care among individuals at increased risk of cardiovascular disease in the community?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy


Assignment

Parallel


Purpose

Prevention


Intervention(s) planned

The study will be conducted in all Medical Officer of Health areas except the Colombo Municipal Council area in the Colombo District. The primary sampling units are the Grama Niladhari divisions

The eligible participants, after obtaining informed written consent, will be assigned either to intervention or control arm using block randomization.

The intervention arm will receive a M-Health nutrition and lifestyle package developed in consultation with relevant experts in the fields of nutrition, public health, clinical medicine, and information and communication technology etc.

The content of the package will comprise of simple, scientifically valid, and culturally acceptable text and voice messages aiming behavior changes in diet and lifestyle factors. The messages will cover healthy eating practices, for example, adding more servings of vegetables or fruits to daily; cut down refine carbohydrates; skip trans-fats, choose fewer saturated fats; and get more healthy fats; engage 30 minutes of exercise daily, stop smoking etc.

These messages will be incorporated to an automated system with interactive and personalized features. The intervention group will receive interactive and personalized mobile phone messages at a frequency of 3 messages per week for a period of 9 months.

Individuals in the control group will not receive any M-Health intervention.

Both groups will be allowed to continue with whatever the interventions they follow currently, without any active intervention or interruption by the study. These may include following available information education and communication material, attending healthy lifestyle clinics, nutrition clinics or any other health promotional activities other than any m-health intervention.

Both Intervention and control groups will be followed up and monitored for the same duration.


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.



Primary outcome(s)

  1. Body mass index
  2. Blood pressure
  3. Fasting Blood glucose
  4. Serum cholesterol and lipid profile
  5. Smoking status
  6. Estimated 10-year cardio vascular risk (calculated using both WHO/ISH risk prediction charts and Framingham risk equation)

Primary outcome(s) - Time of assessment(s)

At baseline and at 9 months after commencement of the intervention


Secondary outcome

  1. Body composition analysis - bio impedance assessment method using Body Composition Analyzer ( model HBF 375)
  2. Dietary intake - QUT & DRU Food Frequency Questionnaire validated for Sri Lanka
  3. Physical activity – IPAQ (international Physical Activity Questionnaire) validated for Sri Lanka
  4. Alcohol use – Same set of questions as in the WHO STEPS survey

Secondary outcome(s) - Time of assessment(s)

  1. Body composition analysis - bio impedance assessment method using Body Composition Analyzer ( model HBF 375)
  2. Dietary intake - QUT & DRU Food Frequency Questionnaire validated for Sri Lanka
  3. Physical activity – IPAQ (international Physical Activity Questionnaire) validated for Sri Lanka
  4. Alcohol use – Same set of questions as in the WHO STEPS survey


Target number/sample size

1232 participants (616 per arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2016-08-01


Anticipated end date

2018-07-31


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, Colombo on 23rd May 2016 (Ref: EC-16-061)


Funding source

National Research Council, Sri Lanka, Grant No. NRC 15-145



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

L. D. J. Upul Senarath
Professor in Community Medicine
Department of Community Medicine, Faculty of Medicine, University of Colombo 25, Kynsey Road, Colombo 00800 Sri Lanka
+94 11 267 7765
+94 71 577 3625
+94 11 269 1581
upul@commed.cmb.ac.lk
http://www.med.cmb.ac.lk/index.php/department-of-commedicine-staff/27-staff-profile/community-staff/206-upul-senarath

Contact Person for Public Queries

L. D. J. Upul Senarath
Professor in Community Medicine
Department of Community Medicine, Faculty of Medicine, University of Colombo 25, Kynsey Road, Colombo 00800 Sri Lanka
+94 11 267 7765
+94 71 577 3625
+94 11 269 1581
upul@commed.cmb.ac.lk
http://www.med.cmb.ac.lk/index.php/department-of-commedicine-staff/27-staff-profile/community-staff/206-upul-senarath


Primary study sponsor/organization

National Research Council

380/72, Baudhdhaloka Mawatha Colombo 00700 Sri Lanka
+94 11 269 7538, +94 11 2675136 .
+94 11 269 7166
nrc@sltnet.lk
www.nrc.gov.lk

Secondary study sponsor (If any)

None