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
調査の概要
状態
介入・治療
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Taabo、コートジボワール
- Taabo Health and Demographic Surveillance
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コンタクト:
- Siaka Koné
- 電話番号:+225 0749069627
- メール:Siaka.kone@csrs.ci
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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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介入なし:Control
No intervention is provided besides education on current breastfeeding recommendations.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Prevalence of Complementary Breastfeeding
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Weight-for-Age z-score
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-50
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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