- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02427945
Leveraging an Existing Large-scale Safe Water Program to Deliver Nutrition Messages at a Low Marginal Cost
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Evidence Action's Dispensers for Safe Water program currently provides access to safe water for two million people. The program would be able to leverage the existence of this service delivery platform to provide promoters with training on proper nutrition and methods for delivering these messages to target groups.
The intervention is a home visiting program that will provide nutrition advice on complementary feeding to households with children aged 6-24 months. Two types of home visits will be evaluated, a 'traditional visit mode' in which the child's mother receives the visit; and a 'couples visit mode' in which the promoter attempts to involve both the father and mother.
Households in the control group will also receive home visits by promoters but the content of the visit will be restricted to safe water. The same information on safe water will also be provided to households in the treatment group. Hence, the evaluation will measure the additional effect of providing nutrition information on top of information on safe water.
Promoters will provide advice on nutrition and food hygiene to target households, according to criteria established by Evidence Action. Following the Guiding Principles for Complementary Feeding of the Breastfed Child (PAHO/WHO 2003), the intervention will include information on the maintenance of breastfeeding, safe/hygienic preparation and storage of complementary foods, amount of complementary food needed, food consistency, meal frequency and energy density, nutrient content of complementary foods, and feeding after illness. The home visits will be modelled on the MaiMwana Infant Feeding intervention (http://www.maimwana.malawi.net/MaiMwana/Home.html) that has been taking place in Mchinji (Malawi) since 2005.
Households within the treatment group will be provided by a poster to hang in their dwellings with some basic information on nutrition. A random subset of households will be given a small poster in black and white, and the other subset of households will be give a larger color poster.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Busia County
-
Busia, Busia County, Kenya
- Evidence Action
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Children will be included if they are between 0 and 18 months at baseline and live within the catchment area of a water point in which Evidence Action installs a chlorine dispenser
Exclusion Criteria:
- None
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Control
Provision of information on safe water
|
A promoter from Evidence Action will visit the household and provide information on safe water.
|
|
Sperimentale: Treatment traditional
Provision of information on safe water and child nutrition.
The information will be targeted to the mother of the child aged between 6 and 24 months old.
|
A promoter from Evidence Action will visit the household and provide information on safe water, as well as child nutrition (including hygiene on food preparation and storage).
Households will be given a poster to hang in their dwellings with basic nutrition information.
The poster might be smaller and in black and white, or larger and in color.
|
|
Sperimentale: Treatment couple
Provision of information on safe water and child nutrition.
The information will be targeted to the mother of the child aged between 6 and 24 months old, and her husband.
|
A promoter from Evidence Action will visit the household and provide information on safe water, as well as child nutrition (including hygiene on food preparation and storage).
Households will be given a poster to hang in their dwellings with basic nutrition information.
The poster might be smaller and in black and white, or larger and in color.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Height-for-age z-score
Lasso di tempo: Up to 18 months
|
Up to 18 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Knowledge of child nutrition issues measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Child nutritional intake measured using a 7 day Food Frequency Questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a 7 day Food Frequency Questionnaire
|
Up to 18 months
|
|
Child's age when breastfeeding stops measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
A composite index of other anthropometric indicators (includes child's weight for age z-score, child's mid-upper arm circumference, and child's head circumference)
Lasso di tempo: Up to 18 months
|
The composite index will include child's weight for age z-score, child's mid-upper arm circumference, and child's head circumference.
|
Up to 18 months
|
|
Probability that the child suffers from bipedal oedema
Lasso di tempo: Up to 18 months
|
Up to 18 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Household food consumption measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Household consumption measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Total Chlorine Residual score
Lasso di tempo: Up to 18 months
|
Up to 18 months
|
|
|
Labor supply measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Time cooking on the day prior to the interview measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Women's empowerment measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
|
Probability of having a chat with a friend or acquaintance about food or nutrition measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire.
Having a chat in the last 3 days prior to the survey interview.
|
Up to 18 months
|
|
Probability of child suffering from diarrhea measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire.
Suffering from diarrhea in the last 7 days prior to the survey.
Diarrhea is defined as having 3 loose stools in any one day and/or having blood in the stools at least once.
|
Up to 18 months
|
|
Hygiene practices measured using a structured questionnaire
Lasso di tempo: Up to 18 months
|
Measured using a structured questionnaire
|
Up to 18 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marcos Vera-Hernandez, PhD, research fellow
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1827/006
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Malnutrizione infantile
-
MedDay Pharmaceuticals SAEurofins OptimedTerminatoVolontari sani | Compromissione epatica della categoria Child Pugh moderataFrancia, Ungheria
-
The Hospital for Sick ChildrenBill and Melinda Gates Foundation; Aga Khan UniversityAttivo, non reclutanteUnder Five Child Health Nutrizione e immunizzazionePakistan
-
RenJi HospitalCompletatoRapporto conta piastrinica/diametro milza | Classificazione Child-PughCina
-
Stanford UniversityNational Cancer Institute (NCI)TerminatoCarcinoma epatocellulare ricorrente | Child-Pugh Classe A | Child-Pugh Classe BStati Uniti, Giappone
-
Boehringer IngelheimNon più disponibileMalattie polmonari, interstiziali (nelle popolazioni pediatriche) | Malattia polmonare interstiziale infantile (chILD)
-
Ohio State University Comprehensive Cancer CenterVarian Medical SystemsCompletatoChild-Pugh Classe A | Carcinoma epatocellulare in stadio IIIA | Carcinoma epatocellulare in stadio IIIB | Carcinoma epatocellulare in stadio IIIC | Carcinoma epatocellulare in stadio IVA | Carcinoma epatocellulare in stadio IVB | Child-Pugh Classe BStati Uniti
-
Centre Hospitalier Universitaire DijonCompletatoCarcinoma epatocellulare di Child-Pugh AFrancia
-
MindRank AI LtdNon ancora reclutamentoCompromissione Epatica (Lieve e Moderata, Classi A e B di Child-Pugh) | Insufficienza Epatica (ID MeSH: D048550)Cina
-
CatalYm GmbHReclutamentoCarcinoma epatocellulare di Child-Pugh A | Carcinoma epatocellulare non resecabile o metastatico | Fallimento del trattamento di prima linea che includeva un composto anti PD-(L)1 approvatoItalia, Germania
-
Roswell Park Cancer InstituteMerck Sharp & Dohme LLCCompletatoCarcinoma epatocellulare adulto avanzato | Child-Pugh Classe A | Carcinoma epatocellulare in stadio III | Carcinoma epatocellulare in stadio IIIA | Carcinoma epatocellulare in stadio IIIB | Carcinoma epatocellulare in stadio IIIC | Carcinoma epatocellulare in stadio IV | Carcinoma epatocellulare in... e altre condizioniStati Uniti