NCT03297190

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

February 25, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

1.6 years

First QC Date

September 26, 2017

Last Update Submit

June 15, 2022

Conditions

Nutritional Deficiency

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

SMS

ACTIVE COMPARATOR

Participants will receive SMS messages on nutrition and health related topics

Behavioral: SMS

Interpersonal

ACTIVE COMPARATOR

Participants will receive interpersonal counselling on nutrition and health related topics

Behavioral: Interpersonal Counselling

SMS + Interpersonal

ACTIVE COMPARATOR

Participants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics

Behavioral: SMSBehavioral: Interpersonal Counselling

Usual Care

NO INTERVENTION

Interventions

SMSBEHAVIORAL

Receipt of SMS messages on nutrition and health topics

SMSSMS + Interpersonal
Interpersonal CounsellingBEHAVIORAL

Interpersonal counselling on health and nutrition topics

InterpersonalSMS + Interpersonal

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers of children aged 0-12 mo. or pregnant at time of enrollment
  • Consent to participate in the study

You may not qualify if:

  • Unable to consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKI-Tanzania

Dar es Salaam, 11, Tanzania

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

February 25, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Anonymous data to be shared after data analysis is completed.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Approximately 12 mo. after completion, indefinitely
Access Criteria
Fill out data use agreement.

Locations

TA(1)