Severe Acute MalnutritionNCT03140904
Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition
A study testing Standard weekly visits and Monthly visits in people with Severe Acute Malnutrition, run by Epicentre at 1 site in Nigeria.
Trial summary
This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly… Read more about this study
- Who is it for?
- Ages 6 to 59 weeks
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Standard weekly visits and Monthly visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,945 participants
- Where
- 1 siteNigeria
- Study dates
- 23 Jan 2018to 27 Apr 2020
- 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 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 6 to 59 months
- MUAC < 115 mm and/or grade 1-2 edema
- Absence of current illness requiring inpatient care
Who cannot join
- History of allergy to peanuts
- Any other condition in which, in the judgment of the Field Investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition: an Evaluation of Monthly Visits and Home-based Surveillance for Access-limited and High-burden Settings
This study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.
Read the detailed description
This study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.
Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. Caregivers in the monthly visit group will receive additional instruction at admission regarding home-based MUAC measurement and clinical surveillance.
Regardless of intervention assignment, all children with uncomplicated SAM will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. Additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Standard weekly visits, Monthly visits
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard weekly visitsOther
Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge
Monthly visitsOther
Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a monthly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge
| Study group | Role | What they receive |
|---|---|---|
| Standard weekly visits | Other | Standard weekly visits at the outpatient therapeutic feeding center until discharge Receives: Other: Standard weekly visits |
| Monthly visits | Other | Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge Receives: Other: Monthly visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional recovery
Defined by being free from medical complications, MUAC > 125 mm, and no edema for 2 weeks if admitted with edema
Measured: Minimum length of stay is 8 weeks
Secondary outcomes (4)
Hospitalization
Hospitalization, defined as referral to inpatient care for weight/edema change, or failed appetite test, clinical complication necessitating inpatient care
Measured: within 2 months
Daily weight gain (g / kg / day) among recovered children
difference in weight (g)
Measured: within 2 months
Defaulting
3 missed scheduled facility visits in the weekly follow-up group and 1 missed scheduled facility visit in the monthly follow-up group
Measured: within 2 months
Relapse
Maternal report of admission to any therapeutic feeding program
Measured: Within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start23 Jan 2018
- Primary completion30 Nov 2019
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Standard weekly visits at the outpatient therapeutic feeding center until discharge 2. Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge.
- Masking
- None (open label)
- Enrolment
- 3,945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca GRAIS, Study director, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140904
- Sponsor's protocol ID
- Reduced follow-up
- Status last verified
- May 2020
- First submitted
- 28 Apr 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Subject to individual data sharing agreements
Publications
Ali NB, Hitchings MD, Berthe F, Aruna P, Shehu I, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effect of caregiver training on knowledge and confidence of at-home clinical and anthropometric surveillance of children with uncomplicated severe acute malnutrition: analysis of a cross-over cluster randomised trial in Sokoto, Nigeria. BMJ Glob Health. 2025 Oct 6;10(10):e018559. doi: 10.1136/bmjgh-2024-018559.
PubMed 41057203Menzies NA, Berthe F, Hitchings M, Aruna P, Hamza MA, Nanama S, Steve-Edemba C, Shehu I, Grais RF, Isanaka S. Cost-effectiveness of monthly follow-up for the treatment of uncomplicated severe acute malnutrition: An economic evaluation of a randomized controlled trial. PLOS Glob Public Health. 2022 Dec 9;2(12):e0001189. doi: 10.1371/journal.pgph.0001189. eCollection 2022.
PubMed 36962786Hitchings MDT, Berthe F, Aruna P, Shehu I, Hamza MA, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effectiveness of a monthly schedule of follow-up for the treatment of uncomplicated severe acute malnutrition in Sokoto, Nigeria: A cluster randomized crossover trial. PLoS Med. 2022 Mar 1;19(3):e1003923. doi: 10.1371/journal.pmed.1003923. eCollection 2022 Mar.
PubMed 35231024Isanaka S, Hedt-Gauthier BL, Salou H, Berthe F, Grais RF, Allen BGS. Active and adaptive case finding to estimate therapeutic program coverage for severe acute malnutrition: a capture-recapture study. BMC Health Serv Res. 2019 Dec 16;19(1):967. doi: 10.1186/s12913-019-4791-9.
PubMed 31842870
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition: an Evaluation of Monthly Visits and Home-based Surveillance for Access-limited and High-burden Settings
- ClinicalTrials.gov ID
- NCT03140904
- Acronym / sponsor ID
- Reduced follow-up
- Conditions
- Severe Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,945 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 4 May 2017 (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 study will be conducted as a stratified cluster randomized trial. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers will be stratified by size, and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.
Detailed description
This study will be conducted as a stratified cluster randomized trial of a monthly schedule of follow up in the treatment of uncomplicated SAM among children aged 6 to 59 months. The unit of randomization will be the outpatient therapeutic feeding center. The 10 health centers supported by International Medical Corps UK (IMC-UK) will be stratified by size (± 1000 admissions per site per year), and centers within a stratum will be randomized in a 1:1 ratio to one of two schedules of treatment: (1) standard weekly visits or (2) monthly visits with support for home-based surveillance.
Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly or monthly basis until discharge according to the random assignment of the site. Caregivers in the monthly visit group will receive additional instruction at admission regarding home-based MUAC measurement and clinical surveillance.
Regardless of intervention assignment, all children with uncomplicated SAM will receive standard medical care on admission as per national guidelines, and a home visit 2 months following discharge from the nutritional program. Additional data collection, including coverage assessment and economic costing analysis will be used to address the secondary objectives related to the evaluation of coverage and cost-effectiveness, respectively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Standard weekly visits at the outpatient therapeutic feeding center until discharge 2. Monthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge.
| Arm | Type | Receives |
|---|---|---|
| Standard weekly visits | Other | Other: Standard weekly visitsStandard weekly visits at the outpatient therapeutic feeding center until discharge |
| Monthly visits | Other | Other: Monthly visitsMonthly visits at the outpatient therapeutic feeding center with caregiver support for home-based surveillance, with visits scheduled at weeks 4, 8, 10 and 12 until discharge |
Who may qualify
- Ages
- 6 to 59 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age from 6 to 59 months
- MUAC < 115 mm and/or grade 1-2 edema
- Absence of current illness requiring inpatient care
Key exclusion criteria (2 listed)
- History of allergy to peanuts
- Any other condition in which, in the judgment of the Field Investigator, would interfere with or serves as a contraindication to protocol adherence or the ability to give informed consent
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 |
|---|---|---|
| Standard weekly visitsDistribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge | Other | Standard weekly visits |
| Monthly visitsDistribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a monthly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge | Other | Monthly visits |
Primary outcome
Nutritional recovery
Time frame: Minimum length of stay is 8 weeks
Defined by being free from medical complications, MUAC > 125 mm, and no edema for 2 weeks if admitted with edema
4 secondary outcomes
Hospitalization
Time frame: within 2 months
Daily weight gain (g / kg / day) among recovered children
Time frame: within 2 months
Defaulting
Time frame: within 2 months
Relapse
Time frame: Within 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 41057203Ali NB, Hitchings MD, Berthe F, Aruna P, Shehu I, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effect of caregiver training on knowledge and confidence of at-home clinical and anthropometric surveillance of children with uncomplicated severe acute malnutrition: analysis of a cross-over cluster randomised trial in Sokoto, Nigeria. BMJ Glob Health. 2025 Oct 6;10(10):e018559. doi: 10.1136/bmjgh-2024-018559.
- Derived from this study: PubMed 36962786Menzies NA, Berthe F, Hitchings M, Aruna P, Hamza MA, Nanama S, Steve-Edemba C, Shehu I, Grais RF, Isanaka S. Cost-effectiveness of monthly follow-up for the treatment of uncomplicated severe acute malnutrition: An economic evaluation of a randomized controlled trial. PLOS Glob Public Health. 2022 Dec 9;2(12):e0001189. doi: 10.1371/journal.pgph.0001189. eCollection 2022.
- Derived from this study: PubMed 35231024Hitchings MDT, Berthe F, Aruna P, Shehu I, Hamza MA, Nanama S, Steve-Edemba C, Grais RF, Isanaka S. Effectiveness of a monthly schedule of follow-up for the treatment of uncomplicated severe acute malnutrition in Sokoto, Nigeria: A cluster randomized crossover trial. PLoS Med. 2022 Mar 1;19(3):e1003923. doi: 10.1371/journal.pmed.1003923. eCollection 2022 Mar.
- Derived from this study: PubMed 31842870Isanaka S, Hedt-Gauthier BL, Salou H, Berthe F, Grais RF, Allen BGS. Active and adaptive case finding to estimate therapeutic program coverage for severe acute malnutrition: a capture-recapture study. BMC Health Serv Res. 2019 Dec 16;19(1):967. doi: 10.1186/s12913-019-4791-9.
- Individual participant dataSharing planned: Undecided. Subject to individual data sharing agreements
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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.
Rebecca GRAIS study director
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard weekly visits and Monthly visits in people with Severe Acute Malnutrition, run by Epicentre at 1 site in Nigeria.
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 3 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: finished, as of the sponsor's last update on 12 May 2020. 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 Nigeria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nutritional recovery (time frame: Minimum length of stay is 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140904, which also lists 4 linked publications.
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 12 May 2020.