NCT04606706

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
516

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

September 14, 2020

Last Update Submit

November 16, 2021

Conditions

Keywords

Mobile healthEducation interventionMaternalInfantYoung childNutritionStunting

Outcome Measures

Primary Outcomes (7)

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

    Body weight in kg

    6 months

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

    Body mass index in kg/m\^2

    6 months

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

    Body composition in %

    6 months

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

    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

    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

    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

    Socioeconomic status (SES) in Ringgit Malaysia unit

    6 months

Secondary Outcomes (1)

  • Changes in knowledge, attitude and practice of breastfeeding after 6 months of intervention among lactating mothers

    6 months

Other Outcomes (2)

  • Perceptions on mobile health intervention among lactating mothers and their husband

    after 6 months

  • |Experiences on mobile health intervention among lactating mothers and their husband

    after 6 months

Study Arms (2)

Maternal, lactating mother & young child (Intervention)

EXPERIMENTAL

mHealth education intervention for 6 months

Other: Mobile health nutrition education intervention

Maternal, lactating mother & young child (Control)

NO INTERVENTION

Conventional health education

Interventions

Nutrition education will be given through mobile phone

Maternal, lactating mother & young child (Intervention)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • +12 more criteria

You may not qualify if:

  • Pregnant women + husband
  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hamid Jan Jan Mohamed

CONTACT

Norshafawati Abd Azimi

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Quasi-experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 14, 2020

First Posted

October 28, 2020

Study Start

March 1, 2021

Primary Completion

February 28, 2022

Study Completion

September 30, 2022

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations