- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04606706
A mHealth Based Education Intervention on Maternal, Infant and Young Child Nutrition to Prevent Stunting in Kelantan (stunting)
Development and Effectiveness of A Mobile Health-Based Education Intervention on Maternal, Infant and Young Child Nutrition to Prevent Stunting in Kelantan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A) Research Objectives
General Objective
To evaluate the effectiveness of mobile health intervention program and to explore the perceptions and experiences of mobile health intervention among mothers to prevent stunting among infant and young children in Kelantan, Malaysia
- Specific Objectives
Phase 1 - Development of a mobile health education package to prevent stunting among maternal, infant and young children
To develop the mobile health education package for pregnant women, lactating mothers and mothers of young children in preventing stunting among children
Phase 2 - Evaluation of the effectiveness of mobile health intervention program to prevent stunting
- To compare the changes in anthropometric measurement and dietary intake after 6 months of intervention among pregnant women, lactating mothers, infants and children in Kelantan
To compare the changes in knowledge, attitude and practice of breastfeeding after 6 months of intervention among lactating mothers
Phase 3 - Qualitative study
- To explore the perceptions and experiences of mobile health intervention among lactating mothers and their husband
B) Study Location
This study will be conducted in selected 6 districts in Kelantan, Malaysia which are Jeli, Gua Musang, Kuala Krai, Tanah Merah, Pasir Mas and Kota Bharu
C) Sample Size
Sample size for each study group (pregnant women, lactating mothers and children) were calculated by using G-power software.
Total sample size for each group = 150 subjects After including 15% of dropout compensation, the final total sample size calculated for each group of this study = 172 subjects Thus, the total sample size for each arm (intervention and control groups) for each group of study = 86 subjects
For face-to-face interview, subjects will be recruited until saturation is achieved. An estimated 20-30 subjects will be recruited in this study (Mason, 2010). The face-to-face interview will be audio recorded.
D) Population and Sampling Method
This study will involve antenatal mothers with husband, lactating mothers with infant and husband, and children's with mother that will be selected by using multistage sampling method
E) Research Tools
Questionnaire
- Socio-demographic and socio-economic questionnaire
- Belief toward feeding practice questionnaire
- Validated food security questionnaire i. 10 items Radimer/Cornell hunger scale
- Nutrient intake questionnaire i. 3-days 24-hour diet recall
- Validated mental health questionnaire i. Depression, anxiety and stress scale
- Validated knowledge, attitude and practice on breastfeeding and infant and young child feeding questionnaire
- Programme satisfaction questionnaire
F) Anthropometric measurement instrument:
- Baby weighing scale
- Adult weighing scale
- Height measuring scale
- Measuring tape
- Body composition analyzer
G) mHealth Intervention Package
All the messages will be created in Malay language based on the books, booklets, topics and modules that have been developed by World Health Organization (WHO) 2012 and UNICEF 2012, and also have widely and officially used by Ministry of Health Malaysia to educate their patients. Basically, the source of messages that will be created and use are from:
- Knowledge on breastfeeding (based on 13 breastfeeding topics for antenatal and postnatal)
- Knowledge on infant and young child feeding (10 key messages for complementary feeding by WHO 2012 & key messages booklets for Infant and Young Child Feeding (IYCF) practices from UNICEF, 2012 in simplified form)
- Knowledge on bottle handling and bottle feeding
- Knowledge on formula milk preparation
- Knowledge on hand washing
- Information on healthy nutrition intake
H) mHealth Mode of Intervention
Intervention will be conducted by using a mobile phone. Thus, a "call centre" for this mobile health intervention program will be set up in Universiti Sains Malaysia (USM) Health Campus. All the information about breastfeeding, infant and young child feeding, bottle handling and bottle feeding, formula milk preparation, hand washing and nutrition intake will be disseminate through a mobile apps known as WhatsApp and by a phone call. There will be a total of 50 messages for 6 months of intervention which are 2 messages per week (every Tuesday & Thursday). The understanding of information will be evaluate 2 times per month by a phone call. The type of messages that will be used are:
- Text messages
- Voice messages
- Video/graphic messages
- Voice calls
A child growth chart (height) also will be give to respondents with infants and children.
I) Data Collection Procedure
Data collection will be conducted at selected districts and health clinics after obtaining approval from USM Research Ethics Committee and Medical Research and Ethics Committee, Ministry of Health Malaysia. This intervention study will be conducted over 6 months. All of the subjects who meet the inclusion and exclusion criteria will be recruited from the health clinics and will be referred to the call center of this study by a trained nutritionist. The purpose of the study and the randomization process will be explained to the subjects by a nutritionist during subjects recruitment.
All subjects (wife and husband only) will sign the informed consent form and parents permission form (for infant and children). The baseline and after 6 months of intervention data will be collected by a researcher and research assisstants of this study while a face-to-face interview will be collected by a researcher. Thus, this research will involve several procedures for mother, children and husband/father.
Mother:
Each mother will involve in anthropometric measurement (including body weight, height/length, body composition) and have to answer the questionnaire during the first and at the end of the intervention sessions.The questionnaire consist of sosio-demography, sosio-economy, medical history, belief toward food intake, food security, nutrient intake, mental health, knowledge, attitude and practice of breastfeeding and infant nutrition and children, and satisfaction of the programme. The estimate time taken to complete the questionnaire is 30 minutes.
For each mother selected in group 2, additional health related information will be provided periodically through mobile phone for 6 months. Health education information also will be given conventionally at health clinic. Whereas mother in group 1 will receive health education information conventionally at health clinic for 6 months. The subjects will be randomly assigned. The selected subject will also be interviewed at the end of the study.
Children:
All children involved will undergo anthropometric measurements (body weight, length, body composition) during the first and at the end of intervention.
Husband/Father:
For husband/father whom their spouse are selected in group 2, additional health related information will be provided periodically through mobile phone for 6 months. Health education information also will be given conventionally at health clinic. Whereas husband/father whom their spouse are selected in group 1 will receive health education information conventionally at health clinic for 6 months. A few husband/father whom their spouse selected to be interviewed also will be interviewed at the end of intervention.
Each interview will take about 40 to 60 minutes to complete.
Group 1 - Control group; Group 2 - Intervention group
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hamid Jan Jan Mohamed
- Phone Number: 7618 +6097677508
- Email: hamidjan@usm.my
Study Contact Backup
- Name: Norshafawati Abd Azimi
- Phone Number: 7680 +6097677508
- Email: shafa.azimi@gmail.com
Study Locations
-
-
Kelantan
-
Kubang Kerian, Kelantan, Malaysia, 16150
- Recruiting
- Universiti Sains Malaysia
-
Contact:
- Hamid Jan Jan Mohamed
-
Principal Investigator:
- Norshafawati Abd Azimi
-
Sub-Investigator:
- Tengku Alina Tengku Ismail
-
Sub-Investigator:
- Hafzan Yusoff
-
Sub-Investigator:
- Yee Cheng Kueh
-
Sub-Investigator:
- Surianti Sukeri
-
Sub-Investigator:
- Zabidi Azhar Mohd Hussin Zabidi-Hussin
-
Sub-Investigator:
- Puspawati Mohamad
-
Sub-Investigator:
- Hamid Jan Jan Mohamed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Pregnant women + husband
- Malaysian
- Pregnant women age 18-35 years during the study
- Height (<155 cm)
- or B40 (household income below Ringgit Malaysia (RM) 2194 in Kelantan)
- or history of stunted child
- or History Gestional Diabetes Mellitus (GDM), anemia, pre-eclampsia
- In second trimester of pregnancy (13-16 weeks)
- Attend the same selected health clinics for the regular medical check-up
- Own a smart phone
Lactation mother + infant + husband
- Malaysian
- Lactation mother age 18-35 years during the study
- Mother height (<155 cm)
- or B40 (household income below RM 2194 in Kelantan)
- or history of stunted child
- New postnatal cases reported to the clinic after delivery
- Attend the selected health clinics for the regular medical check-up
- Own a smart phone
Children + mother + father
- Malaysian
- Children age 6-18 months
- B40 (household income below RM2194 in Kelantan)
- or stunted siblings
- Full terms' babies (deliver after 37 weeks gestation)
- Attend the selected health clinics for the regular medical check-up
- Own a smart phone
Exclusion Criteria:
Pregnant women + husband
1) Multiple pregnancies
Lactation mother + infant + husband
- Babies who have congenital problems/ birth defects
- Stillbirth or foetal death after deliver
Children + mother + father
- Children who have congenital problems/ birth defects
- Single parent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Maternal, lactating mother & young child (Intervention)
mHealth education intervention for 6 months
|
Nutrition education will be given through mobile phone
|
No Intervention: Maternal, lactating mother & young child (Control)
Conventional health education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in body weight after 6 months of intervention among mother, infant and children
Time Frame: 6 months
|
Body weight in kg
|
6 months
|
Changes in body mass index after 6 months of intervention among mother, infant and children
Time Frame: 6 months
|
Body mass index in kg/m^2
|
6 months
|
Changes in body composition after 6 months of intervention among mother, infant and children
Time Frame: 6 months
|
Body composition in %
|
6 months
|
Changes in dietary intake after 6 months of intervention among mother, infant and children
Time Frame: 6 months
|
24-hour diet recall (3-days) in kcal
|
6 months
|
Assessment of food security level after 6 months of intervention among mother, infant and children
Time Frame: 6 months
|
Food security in score (All items are negative answer = secure; If one or more item have positive answer = insecure)
|
6 months
|
Assessment of mental stress after 6 months of intervention among mother, infant and children
Time Frame: 6 months
|
Mental stress in score (Depression if score >9; anxiety if score > 7; stress if score > 14)
|
6 months
|
Assessment of socioeconomic status (SES) after 6 months of intervention among mother, infant and children
Time Frame: 6 months
|
Socioeconomic status (SES) in Ringgit Malaysia unit
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in knowledge, attitude and practice of breastfeeding after 6 months of intervention among lactating mothers
Time Frame: 6 months
|
Total score of knowledge in percentage (A higher percentage means good knowledge), Higher score of attitude means positive attitude
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceptions on mobile health intervention among lactating mothers and their husband
Time Frame: after 6 months
|
Perceptions on mobile health (qualitative-based)
|
after 6 months
|
|Experiences on mobile health intervention among lactating mothers and their husband
Time Frame: after 6 months
|
Experiences on mobile health (qualitative-based)
|
after 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 311/PPSK/4117626
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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