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Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau

7 maggio 2026 aggiornato da: Susan B. Roberts, Trustees of Dartmouth College

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

400

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Guinea Bissau
    • Bissau Region
      • Bissau, Bissau Region, Guinea Bissau, 1000
        • Two villages in rural Guinea-Bissau
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: Regular Growth Monitoring (RGM) by Community Health Agents
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.
Comparatore attivo: 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.
Comportamentale: Regular Growth Monitoring (RGM) by Community Health Agents
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of severe acute malnutrition (SAM)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of moderate acute malnutrition (MAM)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Agreement of new RGM methods vs. reference standard
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Trustees of Dartmouth College

Collaboratori

University of California, San Francisco

Investigatori

  • Investigatore principale: Susan B. Roberts, Ph.D., Dartmouth College

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

2 maggio 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 33690

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Deidentified participant data will be stored and made publicly available at an appropriate repository following publication of the primary manuscript. Participant names stored locally in Guinea-Bissau will be retained for 3 years after study completion and then destroyed. The US team will not have access to identifiable participant information.

Periodo di condivisione IPD

Following publication of the primary manuscript.

Criteri di accesso alla condivisione IPD

Publicly available deidentified dataset; access details to be determined at time of publication.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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 .

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