TY - JOUR
T1 - mHealth nutrition and lifestyle intervention (mHENAL) to reduce cardiovascular disease risk in a middle-aged, overweight and obese population in Sri Lanka
T2 - Study protocol for a randomized controlled trial
AU - Senarath, Upul
AU - Katulanda, Prasad
AU - Fernando, Dulitha N.
AU - Kalupahana, Nishan S.
AU - Partheepan, Kunarathinam
AU - Jayawardena, Ranil
AU - Katulanda, Gaya
AU - Dibley, Michael J.
N1 - Publisher Copyright:
© 2019 The Authors
PY - 2019/12
Y1 - 2019/12
N2 - Mobile phone-based health interventions (mHealth) are viewed as an attractive approach to foster behaviour change, and found to be effective in promoting physical activity and healthy diets. The present study aims to investigate whether mHealth with advice for dietary and lifestyle modifications would reduce 10-year cardio vascular disease (CVD) risk among overweight or obese adults aged 35–64 years in Sri Lanka. A two-group parallel-arm randomized controlled trial (RCT) was conducted in Colombo district, recruiting 1200 individuals aged 35–64 years with a body mass index (BMI) of ≥25 kgm−2. Participants were randomly assigned either to mHealth package (intervention arm, n = 600) or usual care (control arm, n = 600). The intervention package contains a series of dietary and lifestyle improvement messages, a mobile application to register participants, and a web application to deliver these messages. Participants in the intervention arm receive 2 voice and 2 text messages per week to their mobile phones for a period of 12 months. The primary outcome (10-year CVD risk) will be assessed according to sex, age, smoking status, blood pressure, serum cholesterol and glycaemic status. Data are collected at enrollment and after 12 months of intervention on: dietary practices, physical activity, smoking, anthropometry, body composition, blood pressure, fasting plasma glucose, HbA1c and lipid profile. Analysis of effect will be performed by intention-to-treat principle, comparing the outcomes between intervention and control arms. The study resulted in a comprehensive mHealth nutrition and lifestyle package (mHENAL) and successfully completed recruitment and baseline assessment of participants. The message delivery is in progress.
AB - Mobile phone-based health interventions (mHealth) are viewed as an attractive approach to foster behaviour change, and found to be effective in promoting physical activity and healthy diets. The present study aims to investigate whether mHealth with advice for dietary and lifestyle modifications would reduce 10-year cardio vascular disease (CVD) risk among overweight or obese adults aged 35–64 years in Sri Lanka. A two-group parallel-arm randomized controlled trial (RCT) was conducted in Colombo district, recruiting 1200 individuals aged 35–64 years with a body mass index (BMI) of ≥25 kgm−2. Participants were randomly assigned either to mHealth package (intervention arm, n = 600) or usual care (control arm, n = 600). The intervention package contains a series of dietary and lifestyle improvement messages, a mobile application to register participants, and a web application to deliver these messages. Participants in the intervention arm receive 2 voice and 2 text messages per week to their mobile phones for a period of 12 months. The primary outcome (10-year CVD risk) will be assessed according to sex, age, smoking status, blood pressure, serum cholesterol and glycaemic status. Data are collected at enrollment and after 12 months of intervention on: dietary practices, physical activity, smoking, anthropometry, body composition, blood pressure, fasting plasma glucose, HbA1c and lipid profile. Analysis of effect will be performed by intention-to-treat principle, comparing the outcomes between intervention and control arms. The study resulted in a comprehensive mHealth nutrition and lifestyle package (mHENAL) and successfully completed recruitment and baseline assessment of participants. The message delivery is in progress.
KW - Cardiovascular disease
KW - Lifestyle
KW - Mobile phone-based
KW - Nutrition intervention
KW - Obesity
KW - mHealth
UR - http://www.scopus.com/inward/record.url?scp=85072512627&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85072512627&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2019.100453
DO - 10.1016/j.conctc.2019.100453
M3 - Article
AN - SCOPUS:85072512627
SN - 2451-8654
VL - 16
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100453
ER -