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Mobile HealthstuntingNCT04606706

A mHealth Based Education Intervention on Maternal, Infant and Young Child Nutrition to Prevent Stunting in Kelantan

A study testing Mobile health nutrition education intervention in people with Mobile Health and Healthy, run by Universiti Sains Malaysia at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research aimed to develop health module related to nutrition through mobile phone and to access it effectiveness among mother, infant and children (0-2 years old) to prevent stunting in Kelantan, Malaysia. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Mobile Health, Healthy
What is being tested?
Mobile health nutrition education intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 siteMalaysia
Study dates
1 Mar 2021to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 27Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Hamid Jan Jan Mohamed contact

+6097677508 ext. 7618

hamidjan@usm.my

Norshafawati Abd Azimi contact

+6097677508 ext. 7680

shafa.azimi@gmail.com

Malaysia1 site, 1 recruiting
  • Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150

    Hamid Jan Jan Mohamed

    Norshafawati Abd Azimi

    Recruiting

Other trials in Malaysia

About this study

Official title: Development and Effectiveness of A Mobile Health-Based Education Intervention on Maternal, Infant and Young Child Nutrition to Prevent Stunting in Kelantan

This research aimed to develop health module related to nutrition through mobile phone and to access it effectiveness among mother, infant and children (0-2 years old) to prevent stunting in Kelantan, Malaysia. Besides, to evaluate the effectiveness of intervention in reducing stress among pregnant and lactating women. The mobile health (mHealth) messaging interventions will be delivered via a mobile app known as WhatsApp and by a phone call. There will be a total of 50 messages for 6 months of intervention in which 2 messages will be delivered per week (every Tuesday \& Thursday). The understanding of information will be evaluated 2 times per month by a phone call. The type of messages that will be used are text messages, voice messages, video/graphic messages, and voice calls. The assessment using a brief questionnaire and anthropometry measurement will be conducted during first and at the end of the intervention. The effectiveness and perceptions as well as experiences of mobile health intervention will also be assessed.

Read the detailed description
  1. Research Objectives
  2. 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
  3. Specific Objectives

Phase 1 - Development of a mobile health education package to prevent stunting among maternal, infant and young children

  1. 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
  2. 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
  3. To compare the changes in knowledge, attitude and practice of breastfeeding after 6 months of intervention among lactating mothers Phase 3 - Qualitative study
  4. To explore the perceptions and experiences of mobile health intervention among lactating mothers and their husband
  5. 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

  1. 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.

  1. 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

  1. Research Tools
  2. Questionnaire
  3. Socio-demographic and socio-economic questionnaire
  4. Belief toward feeding practice questionnaire
  5. Validated food security questionnaire i. 10 items Radimer/Cornell hunger scale
  6. Nutrient intake questionnaire i. 3-days 24-hour diet recall
  7. Validated mental health questionnaire i. Depression, anxiety and stress scale
  8. Validated knowledge, attitude and practice on breastfeeding and infant and young child feeding questionnaire
  9. Programme satisfaction questionnaire
  10. Anthropometric measurement instrument:
  11. Baby weighing scale
  12. Adult weighing scale
  13. Height measuring scale
  14. Measuring tape
  15. Body composition analyzer
  16. 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:

  1. Knowledge on breastfeeding (based on 13 breastfeeding topics for antenatal and postnatal)
  2. 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)
  3. Knowledge on bottle handling and bottle feeding
  4. Knowledge on formula milk preparation
  5. Knowledge on hand washing
  6. Information on healthy nutrition intake
  7. 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:

  1. Text messages
  2. Voice messages
  3. Video/graphic messages
  4. Voice calls

A child growth chart (height) also will be give to respondents with infants and children.

  1. 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

Being tested
Mobile health nutrition education intervention
Keywords
Mobile health, Education intervention, Maternal, Infant, Young child, Nutrition, Stunting
Medical subject headings
Growth Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile health nutrition education interventionOther

    Nutrition education will be given through mobile phone

Study groups in NCT04606706
Study groupRoleWhat they receive
Maternal, lactating mother & young child (Intervention)ExperimentalmHealth education intervention for 6 months
Receives: Other: Mobile health nutrition education intervention
Maternal, lactating mother & young child (Control)No interventionConventional health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in body weight after 6 months of intervention among mother, infant and children

    Body weight in kg

    Measured: 6 months

  2. Changes in body mass index after 6 months of intervention among mother, infant and children

    Body mass index in kg/m^2

    Measured: 6 months

  3. Changes in body composition after 6 months of intervention among mother, infant and children

    Body composition in %

    Measured: 6 months

  4. Changes in dietary intake after 6 months of intervention among mother, infant and children

    24-hour diet recall (3-days) in kcal

    Measured: 6 months

  5. Assessment of food security level after 6 months of intervention among mother, infant and children

    Food security in score (All items are negative answer = secure; If one or more item have positive answer = insecure)

    Measured: 6 months

  6. Assessment of mental stress after 6 months of intervention among mother, infant and children

    Mental stress in score (Depression if score >9; anxiety if score > 7; stress if score > 14)

    Measured: 6 months

  7. Assessment of socioeconomic status (SES) after 6 months of intervention among mother, infant and children

    Socioeconomic status (SES) in Ringgit Malaysia unit

    Measured: 6 months

Secondary outcomes (1)
  1. Changes in knowledge, attitude and practice of breastfeeding after 6 months of intervention among lactating mothers

    Total score of knowledge in percentage (A higher percentage means good knowledge), Higher score of attitude means positive attitude

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completion28 Feb 2022 (estimated)
  4. Study completion30 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Quasi-experimental design
Masking
Single blind
Who is masked
Participant
Enrolment
516 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04606706
Sponsor's protocol ID
311/PPSK/4117626
Acronym
stunting
Status last verified
Nov 2021
First submitted
14 Sep 2020
Last updated
17 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mobile health nutrition education intervention in people with Mobile Health and Healthy, run by Universiti Sains Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hamid Jan Jan Mohamed (+6097677508 ext. 7618, hamidjan@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in body weight after 6 months of intervention among mother, infant and children (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.

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