Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition
NCT ID: NCT03140904
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3945 participants
INTERVENTIONAL
2018-01-23
2020-04-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
OTHER
NONE
Study Groups
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Standard weekly visits
Standard weekly visits at the outpatient therapeutic feeding center until discharge
Standard weekly visits
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 visits
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
Monthly visits
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
Interventions
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Standard weekly visits
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 visits
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
Eligibility Criteria
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Inclusion Criteria
* MUAC \< 115 mm and/or grade 1-2 edema
* Absence of current illness requiring inpatient care
Exclusion Criteria
* 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
6 Weeks
59 Weeks
ALL
No
Sponsors
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Epicentre
OTHER
Responsible Party
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Principal Investigators
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Rebecca GRAIS
Role: STUDY_DIRECTOR
Epicentre
Locations
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Sokoto State Nutrition Centre
Sokoto, , Nigeria
Countries
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References
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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.
Menzies 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.
Hitchings 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.
Isanaka 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.
Other Identifiers
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Reduced follow-up
Identifier Type: -
Identifier Source: org_study_id
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