ClinicalTrials.gg
CompletedNCT05374837IIMAANJEUpdated Dec 30, 2024Results posted

Mobile Messaging for Improved Nutrition

An interventional study of Infant and young child feeding voice messaging intervention in Diet, Healthy and Anemia, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in Senegal. Open to participants aged 6 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-30.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
488
Allocation
Randomized
Ages
6 Months to 23 Months
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Diet, Healthy
  • Anemia

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Keywords

  • Senegal
  • Infant and young child feeding
03

In context

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

This study's enrollment of 488 is above the median of 117 across 1,336 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 23 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-Does not meet study inclusion criteria

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
488 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralInfant 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.

06

What researchers measure

Primary outcomes

  1. Number of Children Who Consume a Minimum Acceptable Diet

    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.

    Time frame: At study completion, an average of 4 months after baseline

  2. Anemia Prevalence of Children

    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.

    Time frame: At study completion, an average of 4 months after baseline

  3. Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline

    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.

    Time frame: Between baseline and study completion, an average of 4 months after baseline

  4. Change in Percentage of Children With Anemia Between Baseline and Endline

    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).

    Time frame: Between baseline and study completion, an average of 4 months after baseline

Secondary outcomes

  1. Frequency of Child Consuming Key Foods in the Past 7 Days

    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.

    Time frame: At study completion, an average of 4 months after baseline

  2. Infant and Young Child Feeding (IYCF) Practices Indicators

    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.

    Time frame: At study completion, an average of 4 months after baseline

  3. Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions

    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.

    Time frame: At study completion, an average of 4 months after baseline

  4. Number of Children Consuming Minimum Meal Frequency

    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)

    Time frame: At study completion, an average of 4 months after baseline

  5. Number of Children Consuming Minimum Dietary Diversity

    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)

    Time frame: At study completion, an average of 4 months after baseline

  6. Percent Change in Frequency of Consuming Key Foods in the Past 7 Days

    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.

    Time frame: Between baseline and study completion, an average of 4 months after baseline

  7. Change in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators

    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.

    Time frame: Between baseline and study completion, an average of 4 months after baseline

  8. Change in Percentage of Children Meeting Minimum Meal Frequency Indicator

    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.

    Time frame: Between baseline and study completion, an average of 4 months after baseline

  9. Change in Percentage of Children Meeting Minimum Dietary Diversity

    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.

    Time frame: Between baseline and study completion, an average of 4 months after baseline

  10. Change in Percentage of Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions

    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.

    Time frame: Between baseline and study completion, an average of 4 months after baseline

07

Results

Posted Dec 30, 2024

Participant flow

We recruited triads (mother, father and child) for this study. The intervention was delivered to mothers and fathers in the triad and the study outcomes were primarily measured in the child.

Participant flow — Overall Study
MilestoneControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Started455632
Child participants started study205283
Mother participants started study205283
Father participants started study4566
Child participants completed the study205283
Mother participants completed the study205283
Father participants completed the study2848
Completed438614
Not completed1718
Withdrew: Lost to follow-up1718

Outcome measures

PrimaryNumber of Children Who Consume a Minimum Acceptable Diet

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.

Time frame:
At study completion, an average of 4 months after baseline
Reported as:
Count of participants · Participants
Number of Children Who Consume a Minimum Acceptable Diet
ParticipantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Consumed minimum acceptable diet (MAD)6792
Did not consume minimum acceptable diet138191
Statistical analysis
  • Control Group · Regression, Logistic · p = 0.145 (The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.) · Odds ratio (or): 0.9585 · 95% CI 0.4276 to 2.1485Odds of consuming a minimum acceptable diet in control group at endline.
  • Infant and Young Child Feeding (IYCF) Voice Messaging Intervention · Regression, Logistic · p = 0.145 (The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.) · Odds ratio (or): 0.9669 · 95% CI 0.43 to 2.1742Odds of consuming a minimum acceptable diet in intervention group at endline.
PrimaryAnemia Prevalence of Children

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.

Time frame:
At study completion, an average of 4 months after baseline
Reported as:
Count of participants · Participants
Anemia Prevalence of Children
ParticipantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Anemia123154
No anemia4782
Statistical analysis
  • Control Group · Regression, Logistic · p = 0.179 (The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.) · Odds ratio (or): 0.3084 · 95% CI 0.1977 to 0.481
  • Infant and Young Child Feeding (IYCF) Voice Messaging Intervention · Regression, Logistic · p = 0.179 (The a priori threshold for statistical significance is \<0.05. The p-value is for the intervention by time interaction.) · Odds ratio (or): 0.438 · 95% CI 0.2983 to 0.6431
PrimaryChange in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline

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.

Time frame:
Between baseline and study completion, an average of 4 months after baseline
Reported as:
Number · percent of participants
Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline
percent of participantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline18.523.7
PrimaryChange in Percentage of Children With Anemia Between Baseline and Endline

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).

Time frame:
Between baseline and study completion, an average of 4 months after baseline
Reported as:
Number · percent of participants
Change in Percentage of Children With Anemia Between Baseline and Endline
percent of participantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Change in Percentage of Children With Anemia Between Baseline and Endline2.9-3.8
SecondaryFrequency of Child Consuming Key Foods in the Past 7 Days

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.

Time frame:
At study completion, an average of 4 months after baseline
Reported as:
Mean · Times key foods consumed in past 7 days
Frequency of Child Consuming Key Foods in the Past 7 Days
Times key foods consumed in past 7 daysControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Frequency of consuming orange fruits and/or vegetables over past 7 days4.7 ± 2.854.97 ± 2.77
Frequency of consuming animal source foods over past 7 days4.40 ± 2.944.55 ± 2.93
Frequency of consuming leafy greens over past 7 days2.03 ± 2.792.05 ± 2.6
Frequency of consuming thick porridge over past 7 days8.88 ± 13.959.51 ± 14.31
Frequency of consuming porridge mixed with nutrient rich foods over past 7 days3.47 ± 4.493.51 ± 4.40
Frequency of consuming sugary foods over the past 7 days6.72 ± 5.256.52 ± 5.16
Frequency of consuming fried foods over the past 7 days1.77 ± 2.481.69 ± 2.52
SecondaryInfant and Young Child Feeding (IYCF) Practices Indicators

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.

Time frame:
At study completion, an average of 4 months after baseline
Reported as:
Count of participants · Participants
Infant and Young Child Feeding (IYCF) Practices Indicators
ParticipantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Bottle feeding — Yes1018
Bottle feeding — No167221
Egg and/or flesh food consumption — Yes123168
Egg and/or flesh food consumption — No82115
Sweet beverage consumption — Yes93178
Sweet beverage consumption — No112105
Unhealthy food consumption — Yes107156
Unhealthy food consumption — No98127
Zero vegetable or fruit consumption — Yes2525
Zero vegetable or fruit consumption — No180258
SecondaryMothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions

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.

Time frame:
At study completion, an average of 4 months after baseline
Reported as:
Count of participants · Participants
Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
ParticipantsControl Group: Mothers in TriadInfant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in TriadControl Group: Fathers in TriadInfant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad
Leafy greens will provide my baby with important nutrients — Strongly agree931131525
Leafy greens will provide my baby with important nutrients — Agree691011222
Leafy greens will provide my baby with important nutrients — Neutral (neither agree or disagree)111611
Leafy greens will provide my baby with important nutrients — Disagree4500
Leafy greens will provide my baby with important nutrients — Strongly disagree0400
Eating animal source foods can prevent anemia — Strongly agree861211523
Eating animal source foods can prevent anemia — Agree831111324
Eating animal source foods can prevent anemia — Neutral (neither agree or disagree)6201
Eating animal source foods can prevent anemia — Disagree1400
Eating animal source foods can prevent anemia — Strongly disagree1100
Feeding my baby multiple times a day is important for his/her growth and development — Strongly agree761031523
Feeding my baby multiple times a day is important for his/her growth and development — Agree7483920
Feeding my baby multiple times a day is important for his/her growth and development — Neutral (neither agree or disagree)61310
Feeding my baby multiple times a day is important for his/her growth and development — Disagree163635
Feeding my baby multiple times a day is important for his/her growth and development — Strongly disagree5400
Feeding my baby orange fruits and vegetables can help their eye health and prevent illness — Strongly agree861261626
Feeding my baby orange fruits and vegetables can help their eye health and prevent illness — Agree891101121
Feeding my baby orange fruits and vegetables can help their eye health and prevent illness — Neutral (neither agree or disagree)2311
Feeding my baby orange fruits and vegetables can help their eye health and prevent illness — Disagree0000
Feeding my baby orange fruits and vegetables can help their eye health and prevent illness — Strongly disagree0000
It is important to limit the amount of sweet and fried foods my baby consumes — Strongly agree55581321
It is important to limit the amount of sweet and fried foods my baby consumes — Agree6789714
It is important to limit the amount of sweet and fried foods my baby consumes — Neutral (neither agree or disagree)202422
It is important to limit the amount of sweet and fried foods my baby consumes — Disagree173836
It is important to limit the amount of sweet and fried foods my baby consumes — Strongly disagree183035
Clear or liquid porridge nourishes my baby — Strongly agree6393924
Clear or liquid porridge nourishes my baby — Agree891201822
Clear or liquid porridge nourishes my baby — Neutral (neither agree or disagree)12401
Clear or liquid porridge nourishes my baby — Disagree81711
Clear or liquid porridge nourishes my baby — Strongly disagree5500
Washing my hands with soap before and after cooking, eating, etc. can help prevent illness — Strongly agree1041441629
Washing my hands with soap before and after cooking, eating, etc. can help prevent illness — Agree73921219
Washing my hands with soap before and after cooking, eating, etc. can help prevent illness — Neutral (neither agree or disagree)0000
Washing my hands with soap before and after cooking, eating, etc. can help prevent illness — Disagree0100
Washing my hands with soap before and after cooking, eating, etc. can help prevent illness — Strongly disagree0200
After six months, breast milk nourishes my baby — Strongly agree2321610
After six months, breast milk nourishes my baby — Agree3636613
After six months, breast milk nourishes my baby — Neutral (neither agree or disagree)12912
After six months, breast milk nourishes my baby — Disagree4975713
After six months, breast milk nourishes my baby — Strongly disagree6810500
SecondaryNumber of Children Consuming Minimum Meal Frequency

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)

Time frame:
At study completion, an average of 4 months after baseline
Reported as:
Count of participants · Participants
Number of Children Consuming Minimum Meal Frequency
ParticipantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Consumed minimum meal frequency121142
Did not consume minimum meal frequency84141
Statistical analysis
  • Control Group vs Infant and Young Child Feeding (IYCF) Voice Messaging Intervention · Chi-squared · p = 0.054 (A priori threshold for statistical significance \<0.05.)
SecondaryNumber of Children Consuming Minimum Dietary Diversity

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)

Time frame:
At study completion, an average of 4 months after baseline
Reported as:
Count of participants · Participants
Number of Children Consuming Minimum Dietary Diversity
ParticipantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Did not meet minimum dietary diversity85102
Met minimum dietary diversity91136
Statistical analysis
  • Control Group vs Infant and Young Child Feeding (IYCF) Voice Messaging Intervention · Chi-squared · p = 0.65 (A priori threshold for statistical significance \<0.05)
SecondaryPercent Change in Frequency of Consuming Key Foods in the Past 7 Days

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.

Time frame:
Between baseline and study completion, an average of 4 months after baseline
Reported as:
Mean · percent change
Percent Change in Frequency of Consuming Key Foods in the Past 7 Days
percent changeControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Percent change in frequency of consuming orange fruits and/or vegetables over past 7 days44.4 ± 161.451.6 ± 157.3
Percent change in frequency of consuming animal source foods over past 7 days71.6 ± 176.546.1 ± 150.7
Percent change in frequency of consuming leafy greens over past 7 days31.1 ± 170.856.7 ± 208.5
Percent change in frequency of consuming thick porridge over past 7 days5.2 ± 268.515.0 ± 288.3
Percent change in frequency of consuming porridge mixed with nutrient rich foods over past 7 days52.0 ± 282.848.6 ± 270.9
Percent change in frequency of consuming sugary foods over the past 7 days90.7 ± 276.8117.2 ± 315.0
Percent change in frequency of consuming fried foods over the past 7 days17.7 ± 187.4-35.1 ± 123.8
SecondaryChange in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators

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.

Time frame:
Between baseline and study completion, an average of 4 months after baseline
Reported as:
Number · percent of participants
Change in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators
percent of participantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Change in percentage of children bottle fed-11.9-7.3
Change in percentage of children fed egg and/or flesh food consumption13.721.2
Change in percentage of children fed sweet beverage consumption17.115.6
Change in percentage of children fed unhealthy food7.311.7
Change in percentage of children fed zero vegetable or fruit-11.7-22.3
SecondaryChange in Percentage of Children Meeting Minimum Meal Frequency Indicator

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.

Time frame:
Between baseline and study completion, an average of 4 months after baseline
Reported as:
Number · percent of participants
Change in Percentage of Children Meeting Minimum Meal Frequency Indicator
percent of participantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Change in Percentage of Children Meeting Minimum Meal Frequency Indicator20.521.6
SecondaryChange in Percentage of Children Meeting Minimum Dietary Diversity

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.

Time frame:
Between baseline and study completion, an average of 4 months after baseline
Reported as:
Number · percent of participants
Change in Percentage of Children Meeting Minimum Dietary Diversity
percent of participantsControl GroupInfant and Young Child Feeding (IYCF) Voice Messaging Intervention
Change in Percentage of Children Meeting Minimum Dietary Diversity29.336.6
SecondaryChange in Percentage of Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions

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.

Time frame:
Between baseline and study completion, an average of 4 months after baseline
Reported as:
Number · percent of participants
Change in Percentage of Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
percent of participantsControl Group: Mothers in TriadInfant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in TriadControl Group: Fathers in TriadInfant and Young Child Feeding (IYCF) Voice Messaging: Fathers in Triad
Change in percentage of mothers/fathers strongly agreeing leafy greens provide important nutrients19.416.92.521.8
Change in percentage of mothers/fathers strongly agreeing animal source foods can prevent anemia5.76.84.723.7
Change in percentage of mothers/fathers strongly agree feeding baby multiple times/day is important6.89.218.025.2
Change in percentage of mothers/fathers strongly agree feeding orange fruits/vegetables is important1.32.91.622.4
Change in percentage of mothers/fathers strongly agree that limiting amount of sweet and fried foods-8.0-10.4-0.221.0
Change in percentage of mothers/fathers that strongly agree clear or liquid porridge nourishes baby-11.7-6.3-16.818.2
Change in percentage of mothers/fathers that strongly agree about importance of washing hands-3.2-3.4-5.110.4
Change in percentage of mothers/fathers that believe breast milk nourishes baby after 6 mths8.14.63.713.3

Adverse events

Collected over Adverse event data was collected over the course of the intervention (approximately 6 months (inclusive of baseline and endline data collection)) for the triad (mothers, fathers, children).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group - Children0/205 (0%)0/205 (0%)0/205 (0%)
Control Group - Mothers0/205 (0%)0/205 (0%)0/205 (0%)
Control Group - Fathers0/45 (0%)0/45 (0%)0/45 (0%)
Infant and Young Child Feeding - (IYCF) Voice Messaging Intervention - Children0/283 (0%)0/283 (0%)0/283 (0%)
Infant and Young Child Feeding - (IYCF) Voice Messaging Intervention - Mothers0/283 (0%)0/283 (0%)0/283 (0%)
Infant and Young Child Feeding - (IYCF) Voice Messaging Intervention - Fathers0/66 (0%)0/66 (0%)0/66 (0%)

Baseline characteristics

The study population is triads (mother, father, child). Some baseline population characteristics were collected for the triad (race/ethnicity, region) and others are specific to the mother, father, or child. 205 mothers; 205 children; and 45 fathers were included at baseline.

Age, Continuous
Age, Continuous(Months of child)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Child12.3 ± 4.611.6 ± 4.111.9 ± 4.3
Age, Continuous
Age, Continuous(Years of mother)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Mean28.67 ± 8.0627.76 ± 7.4528.15 ± 7.72
Age, Continuous
Age, Continuous(Years of father)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Mean42.67 ± 8.1841.89 ± 9.5542.21 ± 8.99
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Child participants — Female92145237
Child participants — Male113138251
Mother participants — Female205283488
Mother participants — Male000
Father participants — Female000
Father participants — Male4566111
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Ethnicity of triad/household — Wolof/Lebou147194341
Ethnicity of triad/household — Pular/Toucouleur13619
Ethnicity of triad/household — Serere3975114
Ethnicity of triad/household — Diola202
Ethnicity of triad/household — Manding/Soce246
Ethnicity of triad/household — Other ethnicity246
Region of Enrollment
Region of Enrollment(Participants)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Senegal205283488
Child's mother's highest education level completed
Child's mother's highest education level completed(Participants)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Primary school4266108
Secondary school334578
University549
Did not attend formal school125168293
Prevalence of child anemia
Prevalence of child anemia(Participants)Control GroupInfant and Young Child Feeding (IYCF) Voice Messaging InterventionTotal
Child has no anemia6186147
Child has anemia139192331

17 further baseline measures are reported on the registry.

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Study locations

1 site
  • Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation
    Dakar, Senegal
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05374837
Responsible party
Shauna Downs, PhD MS (Assistant Professor, Rutgers, The State University of New Jersey) — Principal investigator
First posted
May 16, 2022
Start date
Jun 10, 2022
Primary completion
Dec 15, 2022
Completion
Dec 15, 2022
Results posted
Dec 30, 2024
Last update
Dec 30, 2024

Study contacts

Shauna Downs
principal investigator · Rutgers School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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