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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
488

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Senegal
      • Dakar, Senegal
        • Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Behavioral: Infant and young child feeding voice messaging intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
At study completion, an average of 4 months after baseline
Anemia Prevalence of Children
Time Frame: At study completion, an average of 4 months after baseline
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.
At study completion, an average of 4 months after baseline
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.
Between baseline and study completion, an average of 4 months after baseline
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).
Between baseline and study completion, an average of 4 months after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
At study completion, an average of 4 months after baseline
Infant and Young Child Feeding (IYCF) Practices Indicators
Time Frame: At study completion, an average of 4 months after baseline
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.
At study completion, an average of 4 months after baseline
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
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.
At study completion, an average of 4 months after baseline
Number of Children Consuming Minimum Meal Frequency
Time Frame: At study completion, an average of 4 months after baseline
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)
At study completion, an average of 4 months after baseline
Number of Children Consuming Minimum Dietary Diversity
Time Frame: At study completion, an average of 4 months after baseline
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)
At study completion, an average of 4 months after baseline
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.
Between baseline and study completion, an average of 4 months after baseline
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.
Between baseline and study completion, an average of 4 months after baseline
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.
Between baseline and study completion, an average of 4 months after baseline
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
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.
Between baseline and study completion, an average of 4 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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