- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02208531
Transition to Scale of Nutrition and Psychosocial Stimulation Program for Malnourished Children (TTS Bangladesh)
Transition to Scale of an Integrated Program of Nutritional Care and Psychosocial Stimulation to Improve Malnourished Children's Development in Bangladesh
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Over 200 million children <5 yrs do not reach their full potential due to poor nutrition and inadequate cognitive stimulation. Nutritional Care (NC) alone is insufficient to correct developmental deficit in malnourished children and psychosocial stimulation (PS) is also required.
Objectives:
- Pilot two intervention methods and different delivery models of providing NC+PS to refine the intervention and identify any difficulties.
- Conduct a cluster randomized controlled trial (CRCT) of NC+PS on malnourished children.
- Pilot the feasibility of providing NC+PS to groups of mothers instead of individuals through a quasi-experimental design.
Methods: The study consists of 3 different sub-studies:
- The pilot will be a qualitative study conducted in 10 Community Clinics (CCs) involving 40 children (aged 6-33 months) per CC. Mothers and children will attend the clinic every 2 weeks for an hour play session in groups of 2 or 6. We will explore different delivery models and assess problems through focus group discussions with parents and staff of the CCs.
- For the CRCT we will survey all children aged 6-24 mo in 140 CCs to identify those malnourished. We will then randomize the CCs to NC+PS or control, randomly select 40 children from each CC and evaluate a random subsample of 6 children from each of the CCs using anthropometry, Bayley-III, Wolke's behavior rating and family care indicators (FCI) at baseline and endline.
- The quasi experimental study will be conducted in 10 CCs randomized to group-intervention or control with 40 mothers and children per CC. Mothers will come to the CCs in groups of 6 with their children every fortnight. The children will be tested at the beginning and after 12 months using the same tools in the main study.
Outcome variable: The main outcomes are children's language, mental and psychomotor development measured on Bayley-III. In addition we expect improvements in FCI and mother's child rearing knowledge and practices. We will also conduct cost analysis and based on the success indicators, cost per successful outcome will be calculated from total cost of intervention program.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Dhaka, Bangladesch, 1212
- International Centre for Diarrhoeal Disease Research, Bangladesh
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Moderately and Severely malnourished children WAZ<-2SD
- Age: 6-24 months
- Both male and female children
- Living within 30 minutes walk from the Community Clinic
- Parents giving consent to participate in the study
Exclusion Criteria:
- Severe Acute Malnutrition with complications requiring close monitoring and/or hospitalization
- Severe clinical pallor
- Known chronic diseases like epilepsy, cerebral palsy, mental retardation
- Twin/multiple birth
Children with above exclusion criteria or those whose parents do not wish to sign the consent form will not be included in the evaluation sample but if they wish they will receive the stimulation.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Kontrolle
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Experimental: Psychosocial Stimulation and Nutritional Care
Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
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Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cognitive, Language and Motor Composite Scores
Zeitfenster: 12 months
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The outcomes are measured on Bayley-III test.
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12 months
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Anthropometry multiple measures, viz. Weight, length/height and head circumference
Zeitfenster: 12 months
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Children's weight, length/height and head circumference will be measured using standard methods.
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12 months
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Behaviour
Zeitfenster: 12 months
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The outcome is measured using Wolke's behaviour ratings during the Bayley-III test.
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12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Family Care Indicators
Zeitfenster: 12 months
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This outcome is measured by interviewing mothers of children about the quality of psychosocial stimulation at home.
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12 months
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Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Mehrin SF, Hasan MI, Tofail F, Shiraji S, Ridout D, Grantham-McGregor S, Hamadani JD, Baker-Henningham H. Integrating a Group-Based, Early Childhood Parenting Intervention Into Primary Health Care Services in Rural Bangladesh: A Cluster-Randomized Controlled Trial. Front Pediatr. 2022 Jun 10;10:886542. doi: 10.3389/fped.2022.886542. eCollection 2022.
- Hamadani JD, Mehrin SF, Tofail F, Hasan MI, Huda SN, Baker-Henningham H, Ridout D, Grantham-McGregor S. Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health. 2019 Mar;7(3):e366-e375. doi: 10.1016/S2214-109X(18)30535-7.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PR-13099
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