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

13. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Aktiv komparator: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of severe acute malnutrition (SAM)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of moderate acute malnutrition (MAM)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Agreement of new RGM methods vs. reference standard
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Trustees of Dartmouth College

Samarbeidspartnere

University of California, San Francisco

Etterforskere

  • Hovedetterforsker: Susan B. Roberts, Ph.D., Dartmouth College

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. mai 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. desember 2026

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene

7. mai 2026

Først lagt ut (Faktiske)

13. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. juli 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 33690

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Following publication of the primary manuscript.

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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