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

July 13, 2026 updated by: 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of severe acute malnutrition (SAM)
Time Frame: 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of moderate acute malnutrition (MAM)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of new RGM methods vs. reference standard
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trustees of Dartmouth College

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Susan B. Roberts, Ph.D., Dartmouth College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 7, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33690

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

Following publication of the primary manuscript.

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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