- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taabo, Côte d’Ivoire
- Taabo Health and Demographic Surveillance
-
Contact:
- Siaka Koné
- Phone Number: +225 0749069627
- Email: Siaka.kone@csrs.ci
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
No Intervention: Control
No intervention is provided besides education on current breastfeeding recommendations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Complementary Breastfeeding
Time Frame: from 12 to 24 months postpartum
|
Prevalence of complementary breastfeeding at 24 months postpartum.
|
from 12 to 24 months postpartum
|
|
Complementary Breastfeeding Duration
Time Frame: from 12 to 24 months postpartum
|
Duration of complementary breastfeeding in weeks.
|
from 12 to 24 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight-for-Age z-score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Body Weight
- Signs and Symptoms, Digestive
- Immune System Diseases
- Infections
- Respiratory Tract Diseases
- Body Weight Changes
- Respiration Disorders
- Hematologic Diseases
- Skin Diseases
- Signs and Symptoms, Respiratory
- Skin Diseases, Eczematous
- Dermatitis
- Pathological Conditions, Signs and Symptoms
- Behavior
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- Personal Satisfaction
- Feeding Behavior
- Weight Loss
- Hypersensitivity
- Communicable Diseases
- Eczema
- Anemia
- Cough
- Diarrhea
- Psychological Well-Being
- Breast Feeding
Other Study ID Numbers
- 2025-50
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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