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

NCT07584395 | Not Yet Recruiting

• 1 other identifier: 33690
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderate Acute Malnutrition (MAM); Severe Acute Malnutrition

Keywords

Childhood malnutrition; Growth monitoring; Guinea-Bissau; Wasting; Mid-upper arm circumference

Outcome Measures

Primary Outcomes (1)

• Prevalence of severe acute malnutrition (SAM)

  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)

Secondary Outcomes (4)

• Prevalence of moderate acute malnutrition (MAM)

  Baseline to study completion (~4 months)

• Weight-for-length z-score

  Baseline to study completion (~4 months)

• Weight-for-age z-score

  Baseline to study completion (~4 months)

• Length-for-age z-score

  Baseline and study completion (~4 months)

Other Outcomes (2)

• Agreement of new RGM methods vs. reference standard

  Assessed at each study visit (monthly from baseline to 4 months follow-up)

• Acceptability and feasibility of RGM methods

  N/A, data collected at study completion (4 month visit)

Study Arms (2)

Village #1 (initial start)

EXPERIMENTAL

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.

Behavioral: Regular Growth Monitoring (RGM) by Community Health Agents

Village #2 (delayed start)

ACTIVE COMPARATOR

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.

Behavioral: Regular Growth Monitoring (RGM) by Community Health Agents

Interventions

Regular Growth Monitoring (RGM) by Community Health Agents BEHAVIORAL

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.

Village #1 (initial start); Village #2 (delayed start)

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Two villages in rural Guinea-Bissau

Bissau, Bissau Region, 1000, Guinea-Bissau

Location

MeSH Terms

Conditions

Severe Acute Malnutrition; Cachexia

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Susan B. Roberts, Ph.D.

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel E. Silver, Ph.D., M.P.H.

CONTACT

603-646-6482; rachel.e.silver@dartmouth.edu

Valerie Flaherman, M.D., M.P.H.

CONTACT

415-502-6266; valerie.flaherman@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Dean for Foundational Research

Model Details: In this interventional study model, one village begins RGM first. The second village will begin RGM immediately after final data collection in the first village.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 13, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication of the primary manuscript.
• Access Criteria: Publicly available deidentified dataset; access details to be determined at time of publication.

Locations

GU (1)