mHealth nutrition and lifestyle intervention (mHENAL) to reduce cardiovascular disease risk in a middle-aged, overweight and obese population in Sri Lanka: Study protocol for a randomized controlled trial

Upul Senarath; Prasad Katulanda; Dulitha N Fernando; Nishan S Kalupahana; Kunarathinam Partheepan; Ranil Jayawardena; Gaya Katulanda; Michael J Dibley

doi:10.1016/j.conctc.2019.100453

mHealth nutrition and lifestyle intervention (mHENAL) to reduce cardiovascular disease risk in a middle-aged, overweight and obese population in Sri Lanka: Study protocol for a randomized controlled trial

Contemp Clin Trials Commun. 2019 Sep 19:16:100453. doi: 10.1016/j.conctc.2019.100453. eCollection 2019 Dec.

Authors

Upul Senarath¹, Prasad Katulanda¹, Dulitha N Fernando¹, Nishan S Kalupahana², Kunarathinam Partheepan¹, Ranil Jayawardena¹, Gaya Katulanda³, Michael J Dibley⁴

Affiliations

¹ Faculty of Medicine, University of Colombo, 25 Kynsey Road, Colombo, 00800, Sri Lanka.
² Faculty of Medicine, University of Peradeniya, Peradeniya, 20400, Sri Lanka.
³ Department of Chemical Pathology, National Hospital of Sri Lanka, Regent Street, Colombo, 01000, Sri Lanka.
⁴ The University of Sydney School of Public Health, Faculty of Medicine and Health, Edward Ford Building (A27), The University of Sydney, NSW, 2006, Australia.

Abstract

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, HbA_1c 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.

Keywords: Cardiovascular disease; Lifestyle; Mobile phone-based; Nutrition intervention; Obesity; mHealth.