NCT05374837

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 16, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

December 30, 2024

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

April 27, 2022

Results QC Date

May 21, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

SenegalInfant and young child feeding

Outcome Measures

Primary Outcomes (4)

  • 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.

    At study completion, an average of 4 months after baseline

  • 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.

    At study completion, an average of 4 months after baseline

  • 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.

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

  • 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).

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

Secondary Outcomes (10)

  • Frequency of Child Consuming Key Foods in the Past 7 Days

    At study completion, an average of 4 months after baseline

  • Infant and Young Child Feeding (IYCF) Practices Indicators

    At study completion, an average of 4 months after baseline

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

    At study completion, an average of 4 months after baseline

  • Number of Children Consuming Minimum Meal Frequency

    At study completion, an average of 4 months after baseline

  • Number of Children Consuming Minimum Dietary Diversity

    At study completion, an average of 4 months after baseline

  • +5 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

The control group will not receive any intervention. After the endline data collection is completed, the intervention will be delivered to the control group.

Infant and young child feeding (IYCF) voice messaging intervention

EXPERIMENTAL

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

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.

Infant and young child feeding (IYCF) voice messaging intervention

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation

Dakar, Senegal

Location

Related Publications (1)

  • Downs SM, Gueye D, Sall M, Ndoye B, Sarr NN, Sarr M, Mboup S, Alam NA, Diouf A, Merchant EV, Sackey J. 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. Front Public Health. 2023 Sep 25;11:1258963. doi: 10.3389/fpubh.2023.1258963. eCollection 2023.

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Shauna Downs
Organization
Rutgers School of Public Health

Study Officials

  • Shauna Downs

    Rutgers School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Given the nature of the intervention, it will not be possible to mask the treatment group at endline data collection.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-randomized control trial. Please note that enrollment number reflects the number of triads included in the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 16, 2022

Study Start

June 10, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

December 30, 2024

Results First Posted

December 30, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

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.

Locations