- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07584395
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
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
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rachel E. Silver, Ph.D., M.P.H.
- Phone Number: 603-646-6482
- Email: rachel.e.silver@dartmouth.edu
Study Contact Backup
- Name: Valerie Flaherman, M.D., M.P.H.
- Phone Number: 415-502-6266
- Email: valerie.flaherman@ucsf.edu
Study Locations
-
-
Bissau Region
-
Bissau, Bissau Region, Guinea-Bissau, 1000
- Two villages in rural Guinea-Bissau
-
Contact:
- Raimundo Co
- Phone Number: 245-955-240-0808
- Email: dimundorai@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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.
|
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.
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan B. Roberts, Ph.D., Dartmouth College
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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