Home » Trials » SLCTR/2016/018
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
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SLCTR Registration Number
SLCTR/2016/018
Date of Registration
The date of last modification
Mar 03, 2019
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 or 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 Trial 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
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/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
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
Exclusion criteria
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.
|
[ At baseline and at 9 months after commencement of the intervention ] |
Secondary outcome(s)
|
1.
|
[ At baseline and at 9 months after commencement of the intervention ] |
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
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Research Council, Sri Lanka, Grant No. NRC 15-145
Regulatory approvals
Status
Approved
Date of Approval
2016-05-23
Approval number
16-061
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
