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Completed

NCT Number: NCT03140904

Reducing the Frequency of Follow up and Task Sharing in the Treatment of Uncomplicated Severe Acute Malnutrition

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.

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Key information

Age range

6 week–59 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sokoto State Nutrition Centre

Sokoto, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age from 6 to 59 months
  • MUAC < 115 mm and/or grade 1-2 edema
  • Absence of current illness requiring inpatient care

Exclusion criteria

  • 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

Treatment and study plan

Standard weekly visits

Other

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

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Hospitalization

    Time frame: within 2 months

    Hospitalization, defined as referral to inpatient care for weight/edema change, or failed appetite test, clinical complication necessitating inpatient care

  2. Daily weight gain (g / kg / day) among recovered children

    Time frame: within 2 months

    difference in weight (g)

  3. Defaulting

    Time frame: within 2 months

    3 missed scheduled facility visits in the weekly follow-up group and 1 missed scheduled facility visit in the monthly follow-up group

  4. Relapse

    Time frame: Within 2 months

    Maternal report of admission to any therapeutic feeding program

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 4, 2017
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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