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NCT05374837: IIMAANJE

Mobile Messaging for Improved Nutrition

Completed NA Results posted Last updated 30 December 2024
What this trial tests

NA trial testing Infant and young child feeding voice messaging intervention in Diet, Healthy in 488 participants. Completed in 15 December 2022.

Timeline
10 June 2022
Primary endpoint
15 December 2022
15 December 2022

Quick facts

Lead sponsorRutgers, The State University of New Jersey
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment488
Start date10 June 2022
Primary completion15 December 2022
Estimated completion15 December 2022
Sites1 location across Senegal

Drugs / interventions tested

Conditions studied

Sponsor

Rutgers, The State University of New Jersey

Who can join

Adults 6 Months to 23 Months, any sex, with Diet, Healthy or Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Children Who Consume a Minimum Acceptable Diet Primary · 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

GroupValue95% CI
Control Group67
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention92
Control Group138
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention191
Anemia Prevalence of Children Primary · 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.

GroupValue95% CI
Control Group123
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention154
Control Group47
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention82
Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline Primary · 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

GroupValue95% CI
Control Group18.5
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention23.7
Change in Percentage of Children With Anemia Between Baseline and Endline Primary · 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).

GroupValue95% CI
Control Group2.9
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention-3.8
Frequency of Child Consuming Key Foods in the Past 7 Days Secondary · 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.

Frequency of consuming orange fruits and/or vegetables over past 7 days
GroupValue95% CI
Control Group4.7± 2.85
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention4.97± 2.77
Frequency of consuming animal source foods over past 7 days
GroupValue95% CI
Control Group4.40± 2.94
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention4.55± 2.93
Frequency of consuming leafy greens over past 7 days
GroupValue95% CI
Control Group2.03± 2.79
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention2.05± 2.6
Frequency of consuming thick porridge over past 7 days
GroupValue95% CI
Control Group8.88± 13.95
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention9.51± 14.31
Frequency of consuming porridge mixed with nutrient rich foods over past 7 days
GroupValue95% CI
Control Group3.47± 4.49
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention3.51± 4.40
Frequency of consuming sugary foods over the past 7 days
GroupValue95% CI
Control Group6.72± 5.25
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention6.52± 5.16
Frequency of consuming fried foods over the past 7 days
GroupValue95% CI
Control Group1.77± 2.48
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention1.69± 2.52
Infant and Young Child Feeding (IYCF) Practices Indicators Secondary · 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 descr

Bottle feeding
GroupValue95% CI
Control Group10
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention18
Control Group167
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention221
Egg and/or flesh food consumption
GroupValue95% CI
Control Group123
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention168
Control Group82
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention115
Sweet beverage consumption
GroupValue95% CI
Control Group93
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention178
Control Group112
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention105
Unhealthy food consumption
GroupValue95% CI
Control Group107
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention156
Control Group98
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention127
Zero vegetable or fruit consumption
GroupValue95% CI
Control Group25
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention25
Control Group180
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention258
Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions Secondary · 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.

Leafy greens will provide my baby with important nutrients
GroupValue95% CI
Control Group: Mothers in Triad93
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad113
Control Group: Fathers in Triad15
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad25
Control Group: Mothers in Triad69
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad101
Control Group: Fathers in Triad12
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad22
Control Group: Mothers in Triad11
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad16
Control Group: Fathers in Triad1
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad1
Control Group: Mothers in Triad4
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad5
Control Group: Fathers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad0
Eating animal source foods can prevent anemia
GroupValue95% CI
Control Group: Mothers in Triad86
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad121
Control Group: Fathers in Triad15
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad23
Control Group: Mothers in Triad83
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad111
Control Group: Fathers in Triad13
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad24
Control Group: Mothers in Triad6
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad2
Control Group: Fathers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad1
Control Group: Mothers in Triad1
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad4
Control Group: Fathers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad0
Feeding my baby multiple times a day is important for his/her growth and development
GroupValue95% CI
Control Group: Mothers in Triad76
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad103
Control Group: Fathers in Triad15
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad23
Control Group: Mothers in Triad74
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad83
Control Group: Fathers in Triad9
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad20
Control Group: Mothers in Triad6
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad13
Control Group: Fathers in Triad1
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad0
Control Group: Mothers in Triad16
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad36
Control Group: Fathers in Triad3
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad5
Feeding my baby orange fruits and vegetables can help their eye health and prevent illness
GroupValue95% CI
Control Group: Mothers in Triad86
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad126
Control Group: Fathers in Triad16
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad26
Control Group: Mothers in Triad89
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad110
Control Group: Fathers in Triad11
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad21
Control Group: Mothers in Triad2
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad3
Control Group: Fathers in Triad1
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad1
Control Group: Mothers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad0
Control Group: Fathers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad0
It is important to limit the amount of sweet and fried foods my baby consumes
GroupValue95% CI
Control Group: Mothers in Triad55
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad58
Control Group: Fathers in Triad13
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad21
Control Group: Mothers in Triad67
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad89
Control Group: Fathers in Triad7
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad14
Control Group: Mothers in Triad20
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad24
Control Group: Fathers in Triad2
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad2
Control Group: Mothers in Triad17
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad38
Control Group: Fathers in Triad3
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad6
Clear or liquid porridge nourishes my baby
GroupValue95% CI
Control Group: Mothers in Triad63
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad93
Control Group: Fathers in Triad9
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad24
Control Group: Mothers in Triad89
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad120
Control Group: Fathers in Triad18
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad22
Control Group: Mothers in Triad12
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad4
Control Group: Fathers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad1
Control Group: Mothers in Triad8
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad17
Control Group: Fathers in Triad1
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad1
Washing my hands with soap before and after cooking, eating, etc. can help prevent illness
GroupValue95% CI
Control Group: Mothers in Triad104
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad144
Control Group: Fathers in Triad16
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad29
Control Group: Mothers in Triad73
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad92
Control Group: Fathers in Triad12
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad19
Control Group: Mothers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad0
Control Group: Fathers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad0
Control Group: Mothers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad1
Control Group: Fathers in Triad0
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad0
After six months, breast milk nourishes my baby
GroupValue95% CI
Control Group: Mothers in Triad23
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad21
Control Group: Fathers in Triad6
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad10
Control Group: Mothers in Triad36
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad36
Control Group: Fathers in Triad6
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad13
Control Group: Mothers in Triad1
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad2
Control Group: Fathers in Triad9
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad12
Control Group: Mothers in Triad49
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Mothers in Triad75
Control Group: Fathers in Triad7
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention: Fathers in Triad13
Number of Children Consuming Minimum Meal Frequency Secondary · 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)

GroupValue95% CI
Control Group121
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention142
Control Group84
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention141
Number of Children Consuming Minimum Dietary Diversity Secondary · 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)

GroupValue95% CI
Control Group85
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention102
Control Group91
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention136
Percent Change in Frequency of Consuming Key Foods in the Past 7 Days Secondary · 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.

Percent change in frequency of consuming orange fruits and/or vegetables over past 7 days
GroupValue95% CI
Control Group44.4± 161.4
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention51.6± 157.3
Percent change in frequency of consuming animal source foods over past 7 days
GroupValue95% CI
Control Group71.6± 176.5
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention46.1± 150.7
Percent change in frequency of consuming leafy greens over past 7 days
GroupValue95% CI
Control Group31.1± 170.8
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention56.7± 208.5
Percent change in frequency of consuming thick porridge over past 7 days
GroupValue95% CI
Control Group5.2± 268.5
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention15.0± 288.3
Percent change in frequency of consuming porridge mixed with nutrient rich foods over past 7 days
GroupValue95% CI
Control Group52.0± 282.8
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention48.6± 270.9
Percent change in frequency of consuming sugary foods over the past 7 days
GroupValue95% CI
Control Group90.7± 276.8
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention117.2± 315.0
Percent change in frequency of consuming fried foods over the past 7 days
GroupValue95% CI
Control Group17.7± 187.4
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention-35.1± 123.8
Change in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators Secondary · 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, unhe

Change in percentage of children bottle fed
GroupValue95% CI
Control Group-11.9
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention-7.3
Change in percentage of children fed egg and/or flesh food consumption
GroupValue95% CI
Control Group13.7
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention21.2
Change in percentage of children fed sweet beverage consumption
GroupValue95% CI
Control Group17.1
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention15.6
Change in percentage of children fed unhealthy food
GroupValue95% CI
Control Group7.3
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention11.7
Change in percentage of children fed zero vegetable or fruit
GroupValue95% CI
Control Group-11.7
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention-22.3
Change in Percentage of Children Meeting Minimum Meal Frequency Indicator Secondary · 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.

GroupValue95% CI
Control Group20.5
Infant and Young Child Feeding (IYCF) Voice Messaging Intervention21.6

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The impact and implementation of an mHealth intervention to improve infant and young child feeding in Senegal: IIMAANJE protocol for a cluster randomized control trial.
    Downs SM, Gueye D, Sall M, Ndoye B, et al · · 2023 · cited 4× · PMID 37818304 · DOI 10.3389/fpubh.2023.1258963

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