This study will evaluate the usability, feasibility and practicality of a previously
developed smartphone application with complete alpha and beta testing on pregnancy outcomes
in a cluster randomised control trial (RCT).
The study will be completed by involving the nutrition intervention using either mHealth
interventions or conventional methods that will be carried out among pregnancy women.
Subjects will be allocated into groups according to respective health clinics, namely, two
interventions group which are:
Group 1: mHealth intervention group
Group 2: mHealth intervention group + dietitian consultation
Group 3: control group
which total of 294 eligible subjects will be recruited, with 98 subjects are needed in
respective groups.
This is a cluster-randomised controlled trial. For Malaysia consist of two regions which are
East Malaysia and West (or peninsular) Malaysia and they are actually about 400 miles (640
km) apart. At East Malaysia, we targeted on the area with higher density of population which
are Klang Valley (Kuala Lumpur, Selangor and Putrajaya). As shown in Figure 1, for three
states under Klang Valley, we obtained ethics approval from the Jabatan Kesihatan Negeri
Selangor for Selangor state and Jabatan Kesihatan Wilayah Persekutuan Kuala Lumpur dan
Putrajaya for Putrajaya state. In order to prevent cross contamination between the states, we
use simple random sampling which Selangor been allocated into control group and Putrajaya as
intervention group.
As under Putrajaya states only two clinics granted approval for data collection which are
Presint 9 Health Clinic and Presint 18 Health Clinic. By using cluster sampling method,
Presint 9 Health Clinic was randomised into intervention group 1 which whole cluster
participant will be receiving mHealth intervention alone and Presint 18 Health Clinic into
intervention group 2 which whole cluster participants will receive mHealth intervention group
in addition with personal dietitian consultation.
There are nine districts in Selangor: Gombak, Hulu Langat, Hulu Selangor, Klang, Kuala
Langat, Kuala Selangor, Petaling, Sabak Bernam and Sepang which consist of total of 81 health
clinics, we stratified the number of health clinics within the 25 km radius from the Faculty
of Medicine and Health Sciences, Universiti Putra Malaysia due to the geographical proximity
and financial constraints (limited budget). There were total of 15 health clinics after
stratification and simple random sampling was done which Seri Kembangan health clinics in
Petaling District had been chosen as control group. As this is an intervention study, thus
blinding is not applicable for data collection personnel and participants. The health clinics
that involved in this study will be maternal and child health clinics.
This study will use a set of questionnaires to obtain information on personal information,
anthropometry data, prenatal knowledge, physical activity, psychosocial well-being, dietary
intake, quality of life, sleep quality and gestational weight gain of the subjects, based on
appropriate instruments. Re-assessment will be performed at month-6 and month-9 (delivery)
after baseline measurements. During the re-assessment, the data will be collected again on
dietary intake, physical activity, psychosocial well-being, sleep quality and quality of
life. All subjects will be followed up prospectively until delivery. The follow up data
collection will be matched with the prenatal visit of the pregnant mother to the clinic.