Effectiveness of M-health Education on Pregnancy Outcomes Among Pregnant Women in Klang Valley

Sponsor

Universiti Putra Malaysia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05377151

Collaborator

(none)

294

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Gestational weight gain (GWG), weight gain of a mother during pregnancy, is an important determinant that influence the health outcomes of mothers and fetus. There is an increasing trend of pregnant women using mobile health (mHealth) to assess for pregnancy-related health information. While evidence on the effectiveness of mHealth education on improving pregnancy outcomes among pregnant women is growing, the findings had been inconclusive with scarcity of such data in Malaysia. The objective of the study is to determine the effectiveness of a 9-month mHealth intervention on GWG and other outcomes (prenatal knowledge, physical activity, psychosocial well-being, nutritional status, quality of life and sleep quality) among pregnant women.

Condition or Disease	Intervention/Treatment	Phase
Pregnant Women	Other: Mobile application	N/A

Detailed Description

This study consists of four phases:

Phase 1: Module development and evaluation

Phase 2: Development of mobile application according to the module developed at phase 1

Phase 3: Re-evaluation on the mobile application

Phase 4: Nutrition intervention using either mHealth interventions or conventional methods will be carried out among pregnant women.

Subjects will be allocated into three groups, 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.

A multistage sampling will be used in this study. Selangor and Putrajaya will be selected as study locations. Next, health clinics located at Selangor and Putrajaya will be randomised into control group and intervention group via simple random sampling.

By using purposive sampling, Klinik Kesihatan (KK) Seri Kembangan and KK Batu 14 Puchong at Petaling District will be chosen as study locations.
Following that, cluster sampling is used to avoid contamination, as such KK Presint 11 and KK Presint 14 will be chosen as Group 1 intervention whereas KK Presint 9 and KK Presint 18 will be chosen as Group 2 intervention.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

294 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of M-health Education on Pregnancy Outcomes Among Pregnant Women in Klang Valley

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mobile application (mHealth) intervention only - the subjects will receive mobile application (mHealth) intervention only	Other: Mobile application Nutrition intervention using either mHealth interventions or conventional methods will be carried out among pregnant women). Subjects will be allocated into three groups, namely, two interventions group which are: Group 1: mHealth intervention group (98 subjects) Group 2: mHealth intervention group + dietitian consultation (98 subjects) Group 3: control group (98 subjects)
Experimental: mobile application (mHealth) intervention and dietitian consultation - the subjects will receive the information from both mobile application (mHealth) and dietitian consultation	Other: Mobile application Nutrition intervention using either mHealth interventions or conventional methods will be carried out among pregnant women). Subjects will be allocated into three groups, namely, two interventions group which are: Group 1: mHealth intervention group (98 subjects) Group 2: mHealth intervention group + dietitian consultation (98 subjects) Group 3: control group (98 subjects)
No Intervention: standard usual care- dietitian consultation - the subjects will receive all the related information from the standard usual care- dietitian consultation

Arm

Intervention/Treatment

Experimental: mobile application (mHealth) intervention only

- the subjects will receive mobile application (mHealth) intervention only

Other: Mobile application

Nutrition intervention using either mHealth interventions or conventional methods will be carried out among pregnant women). Subjects will be allocated into three groups, namely, two interventions group which are: Group 1: mHealth intervention group (98 subjects) Group 2: mHealth intervention group + dietitian consultation (98 subjects) Group 3: control group (98 subjects)

Experimental: mobile application (mHealth) intervention and dietitian consultation

- the subjects will receive the information from both mobile application (mHealth) and dietitian consultation

Other: Mobile application

No Intervention: standard usual care- dietitian consultation

- the subjects will receive all the related information from the standard usual care- dietitian consultation

Outcome Measures

Primary Outcome Measures

Changes in Gestational Weight Gain [3 points time (Baseline, 6th month, 9th month/ delivery)]
Weight gain (kg)

Secondary Outcome Measures

Prenatal knowledge [1 point1 time (Baseline)]
The maternal health literacy inventory in pregnancy (MHELIP) MHELIP score to 4 categories: 'inadequate', 'problematic' (which together also define 'limited' health literacy), 'sufficient and 'excellent' (which together also defined 'desired' health literacy): Inadequate= 0-50 Problematic= 50.1-66 Sufficient= 66.1-84 Excellent=84.1-100
Physical activity [2 points time (Baseline, 6th month)]
Pregnancy Physical Activity Questionnaire (PPAQ) The activity was classified by intensity: sedentary (< 1.5 METs), light (1.5- < 3.0 METs), moderate (3.0-6.0 METs) or vigorous (> 6.0 METs) and the average number of MET-hours per week expended in each intensity level was calculated. The higher the score, the more active the subject is.
Psychosocial well-being [3 points time (Baseline, 6th month, 9th month/ delivery)]
Depression Anxiety and Stress Scale (DASS-21) Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. Depression (Normal: 0-9; Mild: 10-13; Moderate: 14-20; Severe: 21-27; Extremely Severe: 28+) Anxiety (Normal: 0-7; Mild: 8-9; Moderate: 10-14; Severe: 15-19; Extremely Severe: 20+) Stress (Normal: 0-14; Mild: 15-18; Moderate: 19-25; Severe: 26-33; Extremely Severe: 34+)
Nutritional status [3 points time (Baseline, 6th month, 9th month/ delivery)]
24-hour dietary recall (2 weekdays and 1 weekend)
Quality of life (well being) [3 points time (Baseline, 6th month, 9th month/ delivery)]
WHO 5 item well being index The raw score is calculated by totalling the figures of the five answers. The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life. To obtain a percentage score ranging from 0 to 100, the raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life.
Sleep quality [3 points time (Baseline, 6th month, 9th month/ delivery)]
Pittsburgh Sleep Quality Index (PSQI) In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Pregnancy outcome (Type of delivery) [1 point time (9th month/ delivery)]
Spontaneous vaginal delivery (SVD): Cephalic/ Breech/ Assisted Breech; Instrumental Delivery: Forceps/ Vacuum; Caesarean: Elective/ Emergency/ Lower segment Caesarean section (LSCS)/ Classical
Pregnancy outcome (Apgar Score) [1 point time (9th month/ delivery)]
@1 minit/ minute and @5 minits/ minutes (Apgar Score 7-10: Good outcome)
Pregnancy outcome (Born term) [1 point time (9th month/ delivery)]
Yes / No (_______ minggu/ week)
Pregnancy outcome (Infant weight) [1 point time (9th month/ delivery)]
weight (kg)
Pregnancy outcome (Infant length) [1 point time (9th month/ delivery)]
length (cm)
Pregnancy outcome (Infant head circumference) [1 point time (9th month/ delivery)]
head circumference (cm)
Pregnancy outcome ( Infant breast circumference) [1 point time (9th month/ delivery)]
breast circumference (cm)
Pregnancy outcome (Infant gender) [1 point time (9th month/ delivery)]
Male/ Female
Pregnancy outcome (Maternal complications) [1 point time (9th month/ delivery)]
Postpartum hemorrhage (PPH)/ Eklampsia / Retained placenta/ Venous thromboembolism (VTE)/ Postpartum depression
Pregnancy outcome (Infant complications) [1 point time (9th month/ delivery)]
Miscarriage/ Prematurity/ Stillbirth/ Congenital anomalies/ Shoulder dystosia/ Jaundice / Respiratory related / Transient Tacypnoiec of newborn (TTN)/ Pneumonia (lung infection)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Malaysian women
18 - 40 years old
Single pregnancy
At first trimester or second trimester
All ethnicities
Meet or did not meet with dietitian before
With or without diseases (diabetes mellitus with/ without low dose insulin, hypertension, hyperlipidaemia, overweight/ obese)
Own smart phone with internet access
All BMI categories

Exclusion Criteria:

Diagnosed by medical doctor with major psychiatric problems (bipolar depression, schizophrenia, suicidal risk)
Multiple pregnancies
On other intervention program
Grand multipara
Severe comorbidities (cardiac diseases, severe anaemia)
Type 1 diabetes mellitus or Type 2 diabetes mellitus with high dose insulin