Acute Malnutrition in ChildhoodNCT05284773
Screening for Acute Malnutrition
A study testing Caretaker MUAC screening - training by health workers and Caretaker MUAC screening - training by caregivers in people with Acute Malnutrition in Childhood, run by University of California, San Francisco.
Trial summary
This project includes a pilot cluster-randomized trial of the efficacy of training caregivers to screen for acute malnutrition (AM) in children aged 6-59 months using mid-upper arm circumference (MUAC) in Burkina Faso. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition in Childhood
- What is being tested?
- Caretaker MUAC screening - training by health workers and Caretaker MUAC screening - training by caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2030to 10 Mar 2035
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 59 months
- All sexes
- No healthy volunteers
- Child
Cluster level:
- Enrollment in the CHAT trial
- Location outside of the Health and Demographic Surveillance System (HDSS)
- Population size < 2000 people
- Verbal consent of the village leader
Individual level:
- Residence in a village participating in the CHAT trial
- Caregiver or guardian of children aged 6-59 months (for intervention training)
- Age 6-59 months (for MUAC screening and some outcome assessments)
- Verbal consent from caregiver or guardian
About this study
Official title: Screening for Acute Malnutrition: a Cluster Randomized Trial Comparing Caregivers to Community Health Workers in Burkina Faso
This project includes a pilot cluster-randomized trial of the efficacy of training caregivers to screen for acute malnutrition (AM) in children aged 6-59 months using mid-upper arm circumference (MUAC) in Burkina Faso. The pilot will be conducted to establish the feasibility of procedures and preliminary outcome data to inform the sample size calculations and design of a future longer-term, fully powered cluster-randomized trial. Forty communities enrolled in the Bill \& Melinda Gates Foundation-funded Child Health with Azithromycin Treatment (CHAT) trial will be randomly selected for this pilot and randomized to receive the caregiver training intervention or no additional intervention. All communities will continue to receive standard of care screening for AM according to national guidelines, which includes community-based screening for AM by community health workers using MUAC every 6 months. A baseline census will be conducted before randomization to enumerate the eligible population of caregivers and children 6-59 months old and measure MUAC. A final census with MUAC measurement will be conducted 6 months later (primary outcome). Data will be collected on all children presenting to the Centre de Santé et Promotion Sociale (CSPS) for malnutrition to track secondary outcomes.
During intervention training, we will also conduct a diagnostic accuracy study to evaluate the validity of caregiver screening by comparing the MUAC measurements of caregivers against the gold standard measurement of the experienced health personnel conducting the training. Also during training, intervention communities will be randomized to one of two training approaches: training by caregivers or training by health agents and adherence to the protocol during follow-up monitoring visits will be compared to determine effectiveness of training.
- Conditions
- Acute Malnutrition in Childhood
- Being tested
- Caretaker MUAC screening - training by health workers, Caretaker MUAC screening - training by caregivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caretaker MUAC screening - training by health workersOther
Study personnel will train caregivers to conduct weekly AM screening using the color-coded MUAC tape. AM screening will involve identifying the midpoint of the child's right arm, wrapping the tape around the mid-point, inserting one end of the tape through the slit at the other end, pulling the tape secure, and reading the measurement based on the color bands. Caregivers will be trained to refer children with yellow or red readings to the nearest CSPS and will be provided with a referral slip to do so. Caregivers will be informed of the signs, symptoms, and consequences of malnutrition as well as the available nutritional programs. Study personnel will conduct monthly supervision visits including brief refresher trainings. In all study communities, standard of care screening for AM will continue. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the CSPS.
Caretaker MUAC screening - training by caregiversOther
Study personnel will train a group of caregivers to perform AM training of all caregivers living in their communities. they will instruct caregivers to conduct weekly AM screening. Training will include the same information as the communities receiving training by Health workers: MUAC training and how to interpret MUAC as well as key concepts of malnutrition. Caregivers will be trained to refer children with yellow or red readings to the nearest CSPS and will be. In all study communities, standard of care screening for AM will continue. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the CSPS.
| Study group | Role | What they receive |
|---|---|---|
| intervention + standard of care | Experimental | Caretakers of children 6-59 months old living in communities assigned to the intervention arm will be trained to detect malnutrition using MUAC on their children weekly. Caretakers living in communities assigned to the intervention will also receive usual standard of care. Receives: Other: Caretaker MUAC screening - training by health workers; Other: Caretaker MUAC screening - training by caregivers |
| standard of care | No intervention | Caretakers of children 6-59 months living in communities assigned to the standard of care arm will receive usual acute malnutrition screening. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the Centre de Sante et Promotion Sociale (CSPS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community-level mean mid-upper arm circumference (MUAC)
Community-level mean MUAC in children 6-59 months of age as assessed during the final census after 6 months of intervention
Measured: 6 months
Secondary outcomes (5)
Sensitivity
Diagnostic accuracy study comparing caregiver measurements to the gold standard measurement from study personnel will include sensitivity as an outcome measure, defined as the number of true positives divided by the total number of cases of global acute malnutrition (MUAC < 125 mm)
Measured: 6 months
Specificity
Diagnostic accuracy study comparing caregiver measurements to the gold standard measurement from study personnel will include specificity as an outcome measure, defined as the number of true negatives divided by the total number of children without global acute malnutrition (MUAC < 125 mm)
Measured: 6 months
Cases referred
Number of cases of AM referred to the CSPS during the study period as collected at the CSPS
Measured: 6 months
Mid-upper arm circumference (MUAC) at admission
MUAC among children 6-59 months of age at admission to CSPS nutritional programs during the study period as routinely collected at the CSPS
Measured: 6 months
Effectiveness of caregiver training
Adherence to protocol in the communities with caretakers training compared to health workers training as measured by caregiver survey and supervisor monitoring checklist. Relevant items from each data collection source will be summarized into a single summary score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start15 Feb 2030 (estimated)
- Primary completion10 Mar 2035 (estimated)
- Study completion10 Mar 2035 (estimated)
Why it stopped: No funding for recruitment of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Malnutrition in ChildhoodStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will be randomized to intervention + standard of care; one group will be randomized to standard of care only
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Catherine Oldenbrug, ScD, Principal investigator, University of California, San FranciscoKieran O'Brien, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284773
- Sponsor's protocol ID
- 17-24230
- Status last verified
- Sep 2024
- First submitted
- 25 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Acute Malnutrition: a Cluster Randomized Trial Comparing Caregivers to Community Health Workers in Burkina Faso
- ClinicalTrials.gov ID
- NCT05284773
- Acronym / sponsor ID
- 17-24230
- Conditions
- Acute Malnutrition in Childhood
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding for recruitment of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso
- Study start
- 15 Feb 2030 (estimated)
- Primary completion
- 10 Mar 2035 (estimated)
- Study completion
- 10 Mar 2035 (estimated)
- First posted
- 17 Mar 2022 (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.
This project includes a pilot cluster-randomized trial of the efficacy of training caregivers to screen for acute malnutrition (AM) in children aged 6-59 months using mid-upper arm circumference (MUAC) in Burkina Faso. The pilot will be conducted to establish the feasibility of procedures and preliminary outcome data to inform the sample size calculations and design of a future longer-term, fully powered cluster-randomized trial. Forty communities enrolled in the Bill \& Melinda Gates Foundation-funded Child Health with Azithromycin Treatment (CHAT) trial will be randomly selected for this pilot and randomized to receive the caregiver training intervention or no additional intervention. All communities will continue to receive standard of care screening for AM according to national guidelines, which includes community-based screening for AM by community health workers using MUAC every 6 months. A baseline census will be conducted before randomization to enumerate the eligible population of caregivers and children 6-59 months old and measure MUAC. A final census with MUAC measurement will be conducted 6 months later (primary outcome). Data will be collected on all children presenting to the Centre de Santé et Promotion Sociale (CSPS) for malnutrition to track secondary outcomes.
During intervention training, we will also conduct a diagnostic accuracy study to evaluate the validity of caregiver screening by comparing the MUAC measurements of caregivers against the gold standard measurement of the experienced health personnel conducting the training. Also during training, intervention communities will be randomized to one of two training approaches: training by caregivers or training by health agents and adherence to the protocol during follow-up monitoring visits will be compared to determine effectiveness of training.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One group will be randomized to intervention + standard of care; one group will be randomized to standard of care only
| Arm | Type | Receives |
|---|---|---|
| intervention + standard of care | Experimental | Other: Caretaker MUAC screening - training by health workers, Other: Caretaker MUAC screening - training by caregiversCaretakers of children 6-59 months old living in communities assigned to the intervention arm will be trained to detect malnutrition using MUAC on their children weekly. Caretakers living in communities assigned to the intervention will also receive usual standard of care. |
| standard of care | No intervention | –Caretakers of children 6-59 months living in communities assigned to the standard of care arm will receive usual acute malnutrition screening. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the Centre de Sante et Promotion Sociale (CSPS). |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Caretaker MUAC screening - training by health workersStudy personnel will train caregivers to conduct weekly AM screening using the color-coded MUAC tape. AM screening will involve identifying the midpoint of the child's right arm, wrapping the tape around the mid-point, inserting one end of the tape through the slit at the other end, pulling the tape secure, and reading the measurement based on the color bands. Caregivers will be trained to refer children with yellow or red readings to the nearest CSPS and will be provided with a referral slip to do so. Caregivers will be informed of the signs, symptoms, and consequences of malnutrition as well as the available nutritional programs. Study personnel will conduct monthly supervision visits including brief refresher trainings. In all study communities, standard of care screening for AM will continue. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the CSPS. | Other | intervention + standard of care |
| Caretaker MUAC screening - training by caregiversStudy personnel will train a group of caregivers to perform AM training of all caregivers living in their communities. they will instruct caregivers to conduct weekly AM screening. Training will include the same information as the communities receiving training by Health workers: MUAC training and how to interpret MUAC as well as key concepts of malnutrition. Caregivers will be trained to refer children with yellow or red readings to the nearest CSPS and will be. In all study communities, standard of care screening for AM will continue. This includes biannual community-based screening by community health workers as well as weekly malnutrition days led by the CSPS. | Other | intervention + standard of care |
Primary outcome
Community-level mean mid-upper arm circumference (MUAC)
Time frame: 6 months
Community-level mean MUAC in children 6-59 months of age as assessed during the final census after 6 months of intervention
5 secondary outcomes
Sensitivity
Time frame: 6 months
Specificity
Time frame: 6 months
Cases referred
Time frame: 6 months
Mid-upper arm circumference (MUAC) at admission
Time frame: 6 months
Effectiveness of caregiver training
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Catherine Oldenbrug, ScD principal investigator
University of California, San Francisco
Kieran O'Brien, PhD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Caretaker MUAC screening - training by health workers and Caretaker MUAC screening - training by caregivers in people with Acute Malnutrition in Childhood, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Community-level mean mid-upper arm circumference (MUAC) (time frame: 6 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 19 Sep 2024.