- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Taabo, Ivoorkust
- Taabo Health and Demographic Surveillance
-
Contact:
- Siaka Koné
- Telefoonnummer: +225 0749069627
- E-mail: Siaka.kone@csrs.ci
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
A social transfer will be given conditioned upon breastfeeding at 24-months postpartum.
|
|
Geen tussenkomst: Control
No intervention is provided besides education on current breastfeeding recommendations.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Prevalence of Complementary Breastfeeding
Tijdsspanne: from 12 to 24 months postpartum
|
Prevalence of complementary breastfeeding at 24 months postpartum.
|
from 12 to 24 months postpartum
|
|
Complementary Breastfeeding Duration
Tijdsspanne: from 12 to 24 months postpartum
|
Duration of complementary breastfeeding in weeks.
|
from 12 to 24 months postpartum
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Weight-for-Age z-score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Ziekte attributen
- Lichaamsgewicht
- Tekenen en symptomen, spijsvertering
- Ziekten van het immuunsysteem
- Infecties
- Ziekten van de luchtwegen
- Veranderingen in lichaamsgewicht
- Ademhalingsstoornissen
- Hematologische ziekten
- Huidziektes
- Tekenen en symptomen, ademhaling
- Huidziekten, Eczeem
- Dermatitis
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Huid- en bindweefselaandoeningen
- Tekenen en symptomen
- Hemische en lymfatische ziekten
- Persoonlijke voldoening
- Voedingsgedrag
- Gewichtsverlies
- Overgevoeligheid
- Overdraagbare ziekten
- Eczeem
- Bloedarmoede
- Hoesten
- Diarree
- Geestelijk welzijn
- Borstvoeding
Andere studie-ID-nummers
- 2025-50
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .