Severe Acute MalnutritionNCT07584395
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
A study testing Regular Growth Monitoring (RGM) by Community Health Agents in people with Severe Acute Malnutrition and Moderate Acute Malnutrition (MAM), run by Trustees of Dartmouth College at 1 site in Guinea-Bissau.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
- What is being tested?
- Regular Growth Monitoring (RGM) by Community Health Agents
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 5 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Guinea-Bissau1 site
Two villages in rural Guinea-Bissau
Bissau, Bissau Region, 1000
About this study
Official title: 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.
Read the 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.
- Being tested
- Regular Growth Monitoring (RGM) by Community Health Agents
- Keywords
- Childhood malnutrition, Growth monitoring, Guinea-Bissau, Wasting, Mid-upper arm circumference
- Medical subject headings
- Severe Acute Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Growth Monitoring (RGM) by Community Health AgentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Regular Growth Monitoring (RGM) by Community Health Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to study completion (~4 months)
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline and study completion (~4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start5 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Susan B. Roberts, Trustees of Dartmouth College
- Investigators
- Susan B. Roberts, Ph.D., Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584395
- Sponsor's protocol ID
- 33690
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Benefits and Sustainability of Regular Growth Monitoring (RGM) of Young Children in Villages in Guinea-Bissau
- ClinicalTrials.gov ID
- NCT07584395
- Acronym / sponsor ID
- 33690
- Keywords
- Childhood malnutrition, Growth monitoring, Guinea-Bissau, Wasting, Mid-upper arm circumference
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 5 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Village #1 (initial start) | Experimental | Behavioral: Regular Growth Monitoring (RGM) by Community Health AgentsChildren 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. |
| Village #2 (delayed start) | Active comparator | Behavioral: Regular Growth Monitoring (RGM) by Community Health AgentsChildren 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular Growth Monitoring (RGM) by Community Health AgentsMonthly 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. | Behavioural | Village #1 (initial start), Village #2 (delayed start) |
Primary outcome
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.
4 secondary outcomes
Prevalence of moderate acute malnutrition (MAM)
Time frame: Baseline to study completion (~4 months)
Weight-for-length z-score
Time frame: Baseline to study completion (~4 months)
Weight-for-age z-score
Time frame: Baseline to study completion (~4 months)
Length-for-age z-score
Time frame: Baseline and study completion (~4 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Severe Acute Malnutrition
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Not yet recruiting
The Relapse to Acute Malnutrition Prevention (RAMP) Trial
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Recruiting
Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia
Acute Malnutrition, Severe, Malnutrition, Child
Active, not recruiting
Choline to Improve Malnutrition and Enhance Cognition
Severe Acute Malnutrition, Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan B. Roberts, Ph.D. principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Growth Monitoring (RGM) by Community Health Agents in people with Severe Acute Malnutrition and Moderate Acute Malnutrition (MAM), run by Trustees of Dartmouth College at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of severe acute malnutrition (SAM) (time frame: Baseline to study completion (~4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.