- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07569172
Improved Child Nutrition and Development Through Social Transfers (TENDER)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Taabo, Côte d’Ivoire
- Taabo Health and Demographic Surveillance
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Kontakt:
- Siaka Koné
- Telefonnummer: +225 0749069627
- E-mail: Siaka.kone@csrs.ci
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Are enrolled in the Taabo multigenerational birth cohort (MGC)
- Completed the postpartum interview of the Taabo MGC
- Have a child who is within two weeks of their 12-month birthday,
- are breastfeeding at time of recruitment,
- live in the Taabo HDSS, Côte d'Ivoire
- have no illnesses that contraindicates breastfeeding,
- had a healthy singleton infant with a birth weight of at least 2500 grams, and
- 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:
- Plans to move permanently outside study area
- Has a medical, intellectual or psychological disability
- Contraindication for breastfeeding
- Children born with < 2500 grams
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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A social transfer will be given conditioned upon breastfeeding at 24-months postpartum.
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Ingen indgriben: Control
No intervention is provided besides education on current breastfeeding recommendations.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Prevalence of Complementary Breastfeeding
Tidsramme: from 12 to 24 months postpartum
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Prevalence of complementary breastfeeding at 24 months postpartum.
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from 12 to 24 months postpartum
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Complementary Breastfeeding Duration
Tidsramme: from 12 to 24 months postpartum
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Duration of complementary breastfeeding in weeks.
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from 12 to 24 months postpartum
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Weight-for-Age z-score
Tidsramme: 12 months; 24 months
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Infants will be weighed in kilograms by a mobile weighing scale.
Measurements will be analyzed as age standardized z-scores.
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12 months; 24 months
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Child Health Outcomes
Tidsramme: 12 months; 24 months
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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.
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12 months; 24 months
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Percent weight loss
Tidsramme: 12 months; 24 months;
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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.
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12 months; 24 months;
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Mother and Child Hemoglobin Levels
Tidsramme: 12 months; 24 months
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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.
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12 months; 24 months
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Maternal Depression
Tidsramme: 12 months; 24 months
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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).
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12 months; 24 months
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Height-for-age z-score
Tidsramme: 12 months; 24 months
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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
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12 months; 24 months
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Mid-upper arm circumference (MUAC)
Tidsramme: 12 months; 24 months
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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.
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12 months; 24 months
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Mother and Child Anemia
Tidsramme: 12 months; 24 months
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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.
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12 months; 24 months
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Maternal weight change
Tidsramme: 12 months; 24 months;
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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;
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Change in systolic and diastolic blood pressure (mmHg)
Tidsramme: 12 months; 24 months;
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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.
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12 months; 24 months;
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Change in systolic and diastolic blood pressure (mmHg)
Tidsramme: 12 months; 24 months;
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Change in systolic and diastolic blood pressure (mmHg) from baseline of the mothers will be analyzed as a continuous measure.
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12 months; 24 months;
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Caregiver Reported Early Development Instruments (CREDI) cognitive z-score
Tidsramme: 12 months; 24 months
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The CREDI long-form will be administered.
Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
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12 months; 24 months
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CREDI language z-score
Tidsramme: 12 months; 24 months
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The CREDI long-form will be administered.
Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
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12 months; 24 months
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CREDI motor z-score
Tidsramme: 12 months; 24 months
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The CREDI long-form will be administered.
Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
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12 months; 24 months
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CREDI social-emotional z-score
Tidsramme: 12 months; 24 months
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The CREDI long-form will be administered.
Raw item data will be converted to norm-referenced z-scores using the CREDI scoring procedure.
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12 months; 24 months
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Maternal Anxiety
Tidsramme: 12 months; 24 months
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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
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12 months; 24 months
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomsegenskaber
- Kropsvægt
- Tegn og symptomer, fordøjelsessystemet
- Sygdomme i immunsystemet
- Infektioner
- Luftvejssygdomme
- Ændringer i kropsvægt
- Respirationsforstyrrelser
- Hæmatologiske sygdomme
- Hudsygdomme
- Tegn og symptomer, luftveje
- Hudsygdomme, eksem
- Dermatitis
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Hud- og bindevævssygdomme
- Tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Personlig tilfredshed
- Fodringsadfærd
- Vægttab
- Overfølsomhed
- Overførbare sygdomme
- Eksem
- Anæmi
- Hoste
- Diarré
- Psykologisk velvære
- Amning
Andre undersøgelses-id-numre
- 2025-50
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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