- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05374837
Mobile Messaging for Improved Nutrition (IIMAANJE)
December 5, 2024 updated by: Shauna Downs, PhD MS, Rutgers, The State University of New Jersey
The Impact and Implementation of a Mobile Messaging Intervention to Improve Infant and Young Child Nutrition in Senegal
This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a cluster-randomized control trial (cRCT) conducted with 488 mother, father, and child triads in 104 villages in three regions in Senegal: Thies, Diourbel and Fatick.
Mothers and fathers in the experimental group will receive 16 voice and text messages over the course of 16 weeks.
One voice and 1 text message with the same content will be sent per week over the 16 week period.
We will include eight scripted messages which have previously been piloted.
We will also include eight unscripted messages from positive deviants from communities similar to our study population that were included in our pilot study.
A text message with the same content as the voice message will be sent to each triad mother and father to increase the reach of the intervention.
We will conduct baseline and endline assessments of infant and young child feeding practices in both the experimental and control groups.
Primary outcomes will include the prevalence of anemia and minimum acceptable diet in children.
Minimum acceptable diet is an indicator of dietary diversity and a proxy for nutrient adequacy.
Secondary outcomes include the frequency of consuming key foods targeted in the intervention over the previous 7 days and infant and young child feeding indicators of complementary feeding of the child.
In addition, infant and young child feeding knowledge, beliefs, and norms (of mothers and fathers in triads) and intentions (of mothers in triads) will be included as secondary outcomes.
Study Type
Interventional
Enrollment (Actual)
488
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dakar, Senegal
- Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 1 year (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Residing in Thies, Diourbel or Fatick regions of Senegal
- Household is member of village farming group
- Mothers and fathers (or caregivers) that have a child 6-19 months at baseline
- Mothers and fathers (or caregivers) that are 18 years or older
- Mothers and fathers (or caregivers) have the ability and mental capacity to consent to their participation
- Mother/father (or male/female caregivers) have access to mobile phone
- Child between 6-19 months at baseline
Exclusion Criteria:
-Does not meet study inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The control group will not receive any intervention.
After the endline data collection is completed, the intervention will be delivered to the control group.
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Experimental: Infant and young child feeding (IYCF) voice messaging intervention
The voice messaging intervention group will receive voice/text messages for a period of 16 weeks.
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A mobile voice and text messaging intervention aimed at improving IYCF practices will be delivered to mothers and fathers with young children (6-23 months).
A total of 16 voice and text message, with the same content, will be sent over a 16-week period (1 voice + 1 text messages (with same content) per week x 16 weeks).
Two types of messages will be included: 1) eight scripted and 2) eight unscripted messages from positive deviants.
The content of the messages include: breastfeeding until two years of age, consuming a variety of foods within a given meal, the consistency of porridge (thick rather than thin), limiting sweets and fried foods, the importance of animal source foods, consuming vitamin A rich fruits and vegetables, consuming leafy greens, handwashing and feeding infants and young children fruits and vegetables produced by the household.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Children Who Consume a Minimum Acceptable Diet
Time Frame: At study completion, an average of 4 months after baseline
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The minimum acceptable diet indicator will be used to assess diet quality in children.
A list-based recall will be used to assess dietary intake over the previous day.
The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months).
Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.
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At study completion, an average of 4 months after baseline
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Anemia Prevalence of Children
Time Frame: At study completion, an average of 4 months after baseline
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Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb < 11 g/dl; moderate 7 ≤ hb < 10 d/dl and severe hb < 7 g/dl.
A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels.
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At study completion, an average of 4 months after baseline
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Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline
Time Frame: Between baseline and study completion, an average of 4 months after baseline
|
The change in percentage of children meeting the minimum acceptable diet indicator between baseline and endline will be used to assess diet quality in children.
A list-based recall will be used to assess dietary intake over the previous day.
The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months).
Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.
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Between baseline and study completion, an average of 4 months after baseline
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Change in Percentage of Children With Anemia Between Baseline and Endline
Time Frame: Between baseline and study completion, an average of 4 months after baseline
|
We will use Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb < 11 g/dl; moderate 7 ≤ hb < 10 d/dl and severe hb < 7 g/dl.
A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels.
The change in child anemia prevalence between baseline and endline will be examined (calculated as endline-baseline/baseline*100).
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Between baseline and study completion, an average of 4 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Child Consuming Key Foods in the Past 7 Days
Time Frame: At study completion, an average of 4 months after baseline
|
The frequency of the child consuming specific foods targeted in the intervention over the course of the previous week (7 days) will be assessed.
More specifically, the number of times that the following foods have been consumed will be assessed: animal source foods, leafy greens, orange colored fruits and vegetables, thick porridge, porridge mixed with nutrient-rich foods, sweets and sugary drinks, fried foods.
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At study completion, an average of 4 months after baseline
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Infant and Young Child Feeding (IYCF) Practices Indicators
Time Frame: At study completion, an average of 4 months after baseline
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The WHO/UNICEF IYCF indicators will be used to assess feeding practices.
Mothers will be asked about feeding practices as part of the household surveys.
The indicators include: ever breastfed, early initiation of breastfeeding, exclusively breastfed for the first two days after birth, bottle feeding 0-23 months, continued breastfeeding 12-23 months, introduction of solid, semi-solid or soft foods 6-8 months, egg and/or flesh food consumption, sweet beverage consumption, unhealthy food consumption, and zero vegetable or fruit.
The proportion of children being fed according to the detailed descriptions of these indicators will be assessed based on the WHO/UNICEF IYCF indicator manual.
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At study completion, an average of 4 months after baseline
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Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
Time Frame: At study completion, an average of 4 months after baseline
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IYCF knowledge, attitudes, norms and intentions will be assessed using survey questions based on the components of the intervention.
Both mothers and fathers will be asked the survey questions as part of the household survey.
The questions are grounded in the theory of planned behavior and based on previously published IYCF knowledge, attitudes, norms and intentions questions.
The questions have been pilot tested by the project PI.
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At study completion, an average of 4 months after baseline
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Number of Children Consuming Minimum Meal Frequency
Time Frame: At study completion, an average of 4 months after baseline
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Minimum meal frequency of (semi) solid or soft foods is assessed by examining the proportion of young children consuming foods: 2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months)
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At study completion, an average of 4 months after baseline
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Number of Children Consuming Minimum Dietary Diversity
Time Frame: At study completion, an average of 4 months after baseline
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The proportion of young children consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables)
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At study completion, an average of 4 months after baseline
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Percent Change in Frequency of Consuming Key Foods in the Past 7 Days
Time Frame: Between baseline and study completion, an average of 4 months after baseline
|
The percent change (calculated as endline-baseline/baseline) in the frequency of consuming specific foods targeted in the intervention over the course of the previous week (7 days) will be assessed between baseline and endline.
More specifically, the number of times that the following foods have been consumed will be assessed: animal source foods, leafy greens, orange colored fruits and vegetables, thick porridge, porridge mixed with nutrient-rich foods, sweets and sugary drinks, fried foods.
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Between baseline and study completion, an average of 4 months after baseline
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Change in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators
Time Frame: Between baseline and study completion, an average of 4 months after baseline
|
The change in percentage of children being fed according to the recommended IYCF practices between baseline and endline.
The WHO/UNICEF IYCF indicators will be used to assess feeding practices.
Mothers will be asked about feeding practices as part of the household surveys.
The indicators include: ever breastfed, early initiation of breastfeeding, exclusively breastfed for the first two days after birth, bottle feeding 0-23 months, continued breastfeeding 12-23 months, introduction of solid, semi-solid or soft foods 6-8 months, egg and/or flesh food consumption, sweet beverage consumption, unhealthy food consumption, and zero vegetable or fruit.
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Between baseline and study completion, an average of 4 months after baseline
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Change in Percentage of Children Meeting Minimum Meal Frequency Indicator
Time Frame: Between baseline and study completion, an average of 4 months after baseline
|
The change in the percentage of children meeting the minimum meal frequency (MMF) indicator between baseline and endline will be assessed.
Minimum meal frequency of (semi) solid or soft foods is assessed by examining the proportion of young children consuming foods: 2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months.
|
Between baseline and study completion, an average of 4 months after baseline
|
|
Change in Percentage of Children Meeting Minimum Dietary Diversity
Time Frame: Between baseline and study completion, an average of 4 months after baseline
|
The change in the percentage of young children consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) between baseline and endline.
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Between baseline and study completion, an average of 4 months after baseline
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Change in Percentage of Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
Time Frame: Between baseline and study completion, an average of 4 months after baseline
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The change in percentage of mothers/fathers with specific IYCF knowledge, attitudes, norms and intentions between baseline and endline will be assessed using survey questions based on the components of the intervention.
Mothers will be asked the survey questions as part of the household survey.
The questions are grounded in the theory of planned behavior and based on previously published IYCF knowledge, attitudes, norms and intentions questions.
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Between baseline and study completion, an average of 4 months after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Shauna Downs, Rutgers School of Public Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2022
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 15, 2022
Study Registration Dates
First Submitted
April 27, 2022
First Submitted That Met QC Criteria
May 10, 2022
First Posted (Actual)
May 16, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 5, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro2021000819
- 1R21HD105067-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Access to the study database will be available for educational, research and non-profit purposes.
All data to be shared will be stripped of any potentially identifying information.
Data will be made available through written request to the PIs.
A brief analysis plan and data request will be required and reviewed by the PI for approval of data sharing.
When requests are approved data will be sent electronically in password protected files.
The final dataset will be available in a cvs file.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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