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Improved Child Nutrition and Development Through Social Transfers (TENDER)

28. april 2026 oppdatert av: Jordyn Wallenborn, Swiss Tropical & Public Health Institute

Taabo Enhanced Nutrition and Development Through Economic Rewards

The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding. It will also learn about the impacts of social transfers on maternal and child health and development. The main questions it aims to answer are:

  • Does the social transfer increase complementary breastfeeding rates at 24-months postpartum?
  • Does the social transfer increase complementary breastfeeding duration?
  • Does the social transfer impact child health and development?
  • Does the social transfer impact maternal physical and mental health?

Researchers will compare a conditional social transfer to a control group that only receives education about breastfeeding recommendations to see if a conditional social transfers works to increase complementary breastfeeding.

Participants will:

Receive a pamphlet explaining the current recommendations of breastfeeding Receive instructions that if they meet the recommendation to breastfeed until 24-months postpartum they receive a social transfer or receive no additional information Complete home visits at 12- and 24-months postpartum Complete detailed questionnaire

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1040

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Côte d’Ivoire
      • Taabo, Côte d’Ivoire
        • Taabo Health and Demographic Surveillance
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Are enrolled in the Taabo multigenerational birth cohort (MGC)
  2. Completed the postpartum interview of the Taabo MGC
  3. Have a child who is within two weeks of their 12-month birthday,
  4. are breastfeeding at time of recruitment,
  5. live in the Taabo HDSS, Côte d'Ivoire
  6. have no illnesses that contraindicates breastfeeding,
  7. had a healthy singleton infant with a birth weight of at least 2500 grams, and
  8. agree to participate and sign an informed consent; if underage (12-17 years), a legal representative will also have to agree to sign the informed consent

Exclusion Criteria:

  1. Plans to move permanently outside study area
  2. Has a medical, intellectual or psychological disability
  3. Contraindication for breastfeeding
  4. Children born with < 2500 grams

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Social Transfer
A social transfer is provided at the 24-month visit, conditional on the mother still breastfeeding at the time of the visit. They also receive education about current breastfeeding recommendations.
Annen: Social Transfer
A social transfer will be given conditioned upon breastfeeding at 24-months postpartum.
Ingen inngripen: Control
No intervention is provided besides education on current breastfeeding recommendations.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of Complementary Breastfeeding
Tidsramme: from 12 to 24 months postpartum
Prevalence of complementary breastfeeding at 24 months postpartum.
from 12 to 24 months postpartum
Complementary Breastfeeding Duration
Tidsramme: from 12 to 24 months postpartum
Duration of complementary breastfeeding in weeks.
from 12 to 24 months postpartum

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Weight-for-Age z-score
Tidsramme: 12 months; 24 months
Infants will be weighed in kilograms by a mobile weighing scale. Measurements will be analyzed as age standardized z-scores.
12 months; 24 months
Child Health Outcomes
Tidsramme: 12 months; 24 months
We will assess the child's health outcomes by using a questionnaire administered to the caregiver. The questionnaire will ask a range of yes or no questions about child diarrhea, respiratory illness, fever, and child antibiotic use.
12 months; 24 months
Percent weight loss
Tidsramme: 12 months; 24 months;
Percent weight loss will use body weight (kg) and pregnancy weight of the mother controlling for time of measurement. Percent weight loss will be calculated as ((current weight - pregnancy weight) / pregnancy weight) × 100.
12 months; 24 months;
Mother and Child Hemoglobin Levels
Tidsramme: 12 months; 24 months
We will assess the mother and child anemia levels. The HemoCue Hb 301 will be used to give an instant measurement of the Haemoglobin (Hb) level of the patient. Capillary blood will be collected through a finger prick. Blood samples drawn for the haemoglobin assessment will be discarded after the test. Iron levels will be analyzed as a continuous outcome.
12 months; 24 months
Maternal Depression
Tidsramme: 12 months; 24 months
Maternal postpartum depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9); categorized as a binary: no depression (score <10) or depression present (score ≥10).
12 months; 24 months
Height-for-age z-score
Tidsramme: 12 months; 24 months
Height will be measured in centimeters by using a Height Measuring Device, stadiometer, 20-205cm. All measurements will be analyzed as age standardized z-scores
12 months; 24 months
Mid-upper arm circumference (MUAC)
Tidsramme: 12 months; 24 months
Infants will be measured for mid-upper arm circumference (MUAC) using non-stretchable measuring tape. All measurements will be analyzed as age standardized z-scores.
12 months; 24 months
Mother and Child Anemia
Tidsramme: 12 months; 24 months
The HemoCue Hb 301 will be used to give an instant measurement of the Haemoglobin (Hb) level of the patient. Capillary blood will be collected through a finger prick. Blood samples drawn for the haemoglobin assessment will be discarded after the test. Hemoglobin levels (gm/dL) will be used to categorize mothers and children into a binary variable: anemic or not anemic.
12 months; 24 months
Maternal weight change
Tidsramme: 12 months; 24 months;

Weight weight change will use body weight (kg) and pregnancy weight of the mother controlling for time of measurement. Maternal weight change will be calculated as the difference between postpartum weight and pregnancy weight. Because pregnancy weight varies by gestational age, analyses will control for gestational age at pregnancy weight measurement and time postpartum at outcome measurement.

Categorized as: no weight loss (0 kg); moderate weight loss (<0 to >-5 kg); high weight loss (≥-5 kg); moderate weight gain (>0 to <5 kg); high weight gain (≥5 kg).
12 months; 24 months;
Change in systolic and diastolic blood pressure (mmHg)
Tidsramme: 12 months; 24 months;
Change in systolic and diastolic blood pressure (mmHg) from baseline of the mothers will be categorized as low, normal, or high according to standard clinical thresholds.
12 months; 24 months;
Change in systolic and diastolic blood pressure (mmHg)
Tidsramme: 12 months; 24 months;
Change in systolic and diastolic blood pressure (mmHg) from baseline of the mothers will be analyzed as a continuous measure.
12 months; 24 months;
Caregiver Reported Early Development Instruments (CREDI) cognitive z-score
Tidsramme: 12 months; 24 months
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
12 months; 24 months
CREDI language z-score
Tidsramme: 12 months; 24 months
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
12 months; 24 months
CREDI motor z-score
Tidsramme: 12 months; 24 months
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
12 months; 24 months
CREDI social-emotional z-score
Tidsramme: 12 months; 24 months
The CREDI long-form will be administered. Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
12 months; 24 months
Maternal Anxiety
Tidsramme: 12 months; 24 months
Maternal postpartum anziety will be assessed using the the GAD-7 (Generalized Anxiety Disorder-7); a seven-item self-report questionnaire designed to measure the severity of anxiety; categorized as: Minimal Anxiety: score 0-4; Mild Anxiety: score 5-9; Moderate Anxiety: score 10-14; Severe Anxiety: score 15-21
12 months; 24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Swiss Tropical & Public Health Institute

Samarbeidspartnere

Centre Suisse de Recherches Scientifique en Côte d'Ivoire

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

28. februar 2028

Studiet fullført (Antatt)

28. februar 2028

Datoer for studieregistrering

Først innsendt

15. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-50

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE

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Nei

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Nei

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