Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition
1 other identifier
interventional
3,945
1 country
1
Brief 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 visits or (2) monthly visits with support for home-based surveillance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedStudy Start
First participant enrolled
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2020
CompletedMay 12, 2020
May 1, 2020
1.9 years
April 28, 2017
May 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Nutritional recovery
Defined by being free from medical complications, MUAC \> 125 mm, and no edema for 2 weeks if admitted with edema
Minimum length of stay is 8 weeks
Secondary Outcomes (4)
Hospitalization
within 2 months
Daily weight gain (g / kg / day) among recovered children
within 2 months
Defaulting
within 2 months
Relapse
Within 2 months
Study Arms (2)
Standard weekly visits
OTHERStandard weekly visits at the outpatient therapeutic feeding center until discharge
Monthly visits
OTHERMonthly 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
Interventions
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
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
You may qualify if:
- age from 6 to 59 months
- MUAC \< 115 mm and/or grade 1-2 edema
- Absence of current illness requiring inpatient care
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epicentrelead
Study Sites (1)
Sokoto State Nutrition Centre
Sokoto, Nigeria
Related Publications (4)
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.
PMID: 41057203DERIVEDMenzies 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.
PMID: 36962786DERIVEDHitchings 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.
PMID: 35231024DERIVEDIsanaka 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.
PMID: 31842870DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rebecca GRAIS
Epicentre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 4, 2017
Study Start
January 23, 2018
Primary Completion
November 30, 2019
Study Completion
April 27, 2020
Last Updated
May 12, 2020
Record last verified: 2020-05