- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07584395
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Pilot Study to Assess the Benefits and Sustainability of Regular Growth Monitoring (RGM) of Young Children in Villages in Guinea-Bissau
Wasting (severe thinness) is a common and serious problem among young children in rural Guinea-Bissau. Community Health Agents (CHAs) can help prevent malnutrition by regularly measuring children's growth and advising families on nutritious local foods. However, this practice is not consistently implemented.
This pilot study will test whether implementing Regular Growth Monitoring (RGM) by CHAs every month is feasible and effective in reducing malnutrition among children aged 6 months to 5 years in two rural villages. Investigators will also compare three methods for measuring mid-upper arm circumference (MUAC), which is used to detect malnutrition: the standard WHO tape measure, a photograph of the arm, and a simple bracelet. The goal is to identify which method is easiest for CHAs to use reliably.
Baseline and final measurements will be taken in both villages. One village will receive the monthly RGM intervention first, followed by the second village. Families will also be asked about their experiences with the program through brief questionnaires.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Wasting is prevalent in rural Guinea-Bissau villages and adversely affects child health and cognitive development long-term. Prior work by this team of investigators suggests that regular feedback from Community Health Agents (CHAs) to caregivers, including recommendations of locally available nutritious recipes for at-risk children, may reduce the incidence of moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). However, routine growth monitoring (RGM) has been largely unfeasible at the village level due to measurement complexity and limited training resources. Modern technology and artificial intelligence may help make this more scalable.
This is a proof-of-concept, sequential pilot study conducted in two villages in Guinea-Bissau with which the team has an established relationship. Baseline anthropometric measurements will be collected on all eligible children (aged 6 months to 5 years, without SAM at enrollment) in both villages. Children identified with SAM at baseline will be referred to the local malnutrition clinic and excluded from the study.
One village will begin the RGM intervention immediately after baseline data collection. The second village will begin the intervention after final data collection in the first village. Assignment order will be by PI decision rather than randomization, as required by the collaborating UCSF team members.
During the RGM period, CHAs will screen each child monthly using all three mid-upper arm circumference (MUAC) methods: (1) WHO tape measure (reference standard), (2) arm photograph, and (3) bracelet. Data will be entered into a secure REDCap database. Children meeting SAM criteria (by tape measure) will be referred to tertiary care; children with MAM will receive weekly CHA nutrition education on local recipes. Measurements collected at baseline and end-of-study include: weight, height, MUAC by all three methods, skinfold thicknesses (biceps and triceps), and family demographics.
After study completion, brief questionnaires will be administered to parents, CHAs, and Ministry of Health staff to assess perceived effects, acceptability, feasibility, and preferences among the monitoring methods. This study has been approved by both the Dartmouth College CPHS and the Ministry of Health in Guinea-Bissau.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Bissau Region
-
Bissau, Bissau Region, Guinée-Bissau, 1000
- Two villages in rural Guinea-Bissau
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Children aged 6 months to 5 years residing in one of the two selected villages in Guinea-Bissau
- Caregiver willing to enroll the child in the study (verbal consent provided)
- Caregiver can provide birth certificate or documentation of child's age
- Child does not have severe acute malnutrition (SAM) at the baseline assessment
Exclusion Criteria:
- Children diagnosed with severe acute malnutrition (SAM) at baseline (these children will be referred to the local malnutrition clinic)
- Children whose caregivers do not wish to participate
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Village #1 (initial start)
Children aged 6 months to 5 years in the first village who do not have SAM at baseline.
This village receives the monthly Regular Growth Monitoring (RGM) intervention immediately after baseline data collection.
CHAs perform monthly MUAC screening using three methods; at-risk children are referred or receive caregiver nutrition education.
|
Monthly malnutrition screening by Community Health Agents (CHAs) using three MUAC methods: (1) WHO standard tape measure, (2) arm photograph for remote review, and (3) a solid bracelet device.
The tape measure is the reference standard.
Children identified with SAM are referred to a tertiary malnutrition clinic; children with MAM have their caregivers provided with weekly education on using local nutritious recipes to support recovery.
Data are entered into REDCap and reviewed remotely by the US research team.
|
|
Comparateur actif: Village #2 (delayed start)
Children aged 6 months to 5 years in the second village who do not have SAM at baseline.
This village serves as a comparison group during the first village's RGM period, then receives the same RGM intervention subsequently.
|
Monthly malnutrition screening by Community Health Agents (CHAs) using three MUAC methods: (1) WHO standard tape measure, (2) arm photograph for remote review, and (3) a solid bracelet device.
The tape measure is the reference standard.
Children identified with SAM are referred to a tertiary malnutrition clinic; children with MAM have their caregivers provided with weekly education on using local nutritious recipes to support recovery.
Data are entered into REDCap and reviewed remotely by the US research team.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of severe acute malnutrition (SAM)
Délai: Baseline to study completion (~4 months)
|
Proportion of enrolled children meeting SAM criteria (by WHO tape measure MUAC) at study completion, compared between early-start and delayed-start villages.
|
Baseline to study completion (~4 months)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Prevalence of moderate acute malnutrition (MAM)
Délai: Baseline to study completion (~4 months)
|
Proportion of enrolled children meeting MAM criteria (by WHO tape measure MUAC) at study completion, compared between early-start and delayed-start villages.
|
Baseline to study completion (~4 months)
|
|
Weight-for-length z-score
Délai: Baseline to study completion (~4 months)
|
Change in weight-for-length z-score between baseline and final assessment, compared between early-start and delayed-start villages
|
Baseline to study completion (~4 months)
|
|
Weight-for-age z-score
Délai: Baseline to study completion (~4 months)
|
Change in weight-for-age z-score between baseline and final assessment, compared between early-start and delayed-start villages.
|
Baseline to study completion (~4 months)
|
|
Length-for-age z-score
Délai: Baseline and study completion (~4 months)
|
Change in length-for-age z-score between baseline and final assessment, compared between early-start and delayed-start villages
|
Baseline and study completion (~4 months)
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Agreement of new RGM methods vs. reference standard
Délai: Assessed at each study visit (monthly from baseline to 4 months follow-up)
|
Accuracy of the arm photograph and bracelet for detecting MAM and SAM relative to the WHO tape measure MUAC.
|
Assessed at each study visit (monthly from baseline to 4 months follow-up)
|
|
Acceptability and feasibility of RGM methods
Délai: N/A, data collected at study completion (4 month visit)
|
Perceived acceptability and feasibility of the three MUAC monitoring methods among parents, CHAs, and Ministry of Health staff, collected via brief structured questionnaires.
|
N/A, data collected at study completion (4 month visit)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Susan B. Roberts, Ph.D., Dartmouth College
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 33690
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .