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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03297190
Other study ID # 20171
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 25, 2018
Est. completion date September 30, 2019

Study information

Verified date June 2022
Source Helen Keller International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This cluster randomized controlled study aims to add to the evidence base on mHealth interventions by assessing the main effects of delivering nutrition messages on key maternal, infant, and young child nutrition (MIYCN) behaviors and outcomes through three innovative behavior change strategies. The strategies compared will be: (i) an interpersonal communication strategy using the Tanzanian government's Mkoba wa Siku 1000 maternal, infant and young child nutrition (MIYCN) curriculum (MwS) through clinic- and community-based channels, (ii) the mNutrition SMS text messaging module of the government's Wazazi Nipendeni program, and (iii) the combination of both of these strategies (interpersonal and SMS messaging). They will be compared with the current standard of care in Tanzania. The goal will be to determine which has the greatest impact on key MIYCN and hygiene practices and care-seeking behaviors. It will be paired with a costing analysis so that these effects can be understood in the context of their costs.


Recruitment information / eligibility

Status Completed
Enrollment 2245
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Mothers of children aged 0-12 mo. or pregnant at time of enrollment - Consent to participate in the study Exclusion Criteria: - Unable to consent to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SMS
Receipt of SMS messages on nutrition and health topics
Interpersonal Counselling
Interpersonal counselling on health and nutrition topics

Locations

Country Name City State
Tanzania HKI-Tanzania Dar es Salaam

Sponsors (2)

Lead Sponsor Collaborator
Helen Keller International Tanzania Food and Nutrition Centre

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Children's Dietary Diversity % of children 6-29 mo. who consumed the minimum dietary diversity (received foods from =4 food groups on the previous day) 24 h
Primary Women's dietary diversity % who consumed food items from at least five out of ten defined food groups in the previous 24 hours (WDDS) 24 h
Primary Children's Minimum Meal Frequency % of children 6-29 mo. who consumed the minimum meal frequency the prior day (2/day for breastfed infants 6-8 mo.; 3/day for breastfed infants 9-29 mo.; 4/day for non-breastfed infants 6-29 mo.) 24 h
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