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

ConditionsSevere Acute Malnutrition Moderate Acute Malnutrition (MAM)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-5

SponsorTrustees of Dartmouth College

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Village #1 (initial start)Experimental treatment 1 intervention

Group B: Village #2 (delayed start)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to study completion (~4 months)

Secondary outcomes

Prevalence of moderate acute malnutrition (MAM)

Proportion of enrolled children meeting MAM criteria (by WHO tape measure MUAC) at study completion, compared between early-start and delayed-start villages.

Time frame

Baseline to study completion (~4 months)

Weight-for-length z-score

Change in weight-for-length z-score between baseline and final assessment, compared between early-start and delayed-start villages

Time frame

Baseline to study completion (~4 months)

Weight-for-age z-score

Change in weight-for-age z-score between baseline and final assessment, compared between early-start and delayed-start villages.

Time frame

Baseline to study completion (~4 months)

Length-for-age z-score

Change in length-for-age z-score between baseline and final assessment, compared between early-start and delayed-start villages

Time frame

Baseline and study completion (~4 months)

Other outcomes

Agreement of new RGM methods vs. reference standard

Accuracy of the arm photograph and bracelet for detecting MAM and SAM relative to the WHO tape measure MUAC.

Time frame

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

Acceptability and feasibility of RGM methods

Perceived acceptability and feasibility of the three MUAC monitoring methods among parents, CHAs, and Ministry of Health staff, collected via brief structured questionnaires.

Time frame

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

Sponsors and contacts

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Trustees of Dartmouth College

Lead sponsor

University of California, San Francisco

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: