Download StudyGeneral

Study Overview

Title:
Combined Protocol for Acute Malnutrition Study
Study ID:
RIDIE-STUDY-ID-58f6eec455b6f
Initial Registration Date:
04/18/2017
Last Update Date:
03/16/2017
Study Status:
Ongoing
Abstract:
Acute malnutrition affects 19 million children under five at any point in time, and can result in death if left untreated. Currently, children can receive treatment for uncomplicated acute malnutrition through outpatient treatment programs. Severe cases are treated through an Outpatient Therapeutic Program (OTP) where children receive routine medical care and a take-home ration of ready-to-use therapeutic food once per week, whereas moderate cases are treated through Supplementary Feeding Programs (SFP) where children receive a take-home ration of ready-to-use supplementary food every two weeks. Ideally, severe cases eventually ‘graduate’ to moderate status. Still this means that children who start as severely malnourished must attend 2 different treatment programs in order to recover. Also, when resources are limited, OTPs are prioritized, leaving moderately malnourished children no option for treatment-until they deteriorate into severe status. This study is aiming to simplify and unify the treatment of uncomplicated severe and moderate acute malnutrition for children 6-59 months into one program and to investigate the effectiveness of this combined protocol.
Categories:
Health, Nutrition, and Population
Additional Keywords:
ComPAS
Secondary ID Number(s):
AID-OFDA-G-14-00208 (OFDA)

Principal Investigator(s)

Name of First PI:
Jeanette Bailey
Affiliation:
The International Rescue Committee
Name of Second PI:
Affiliation:

Study Sponsor

Name:
London School of Hygiene and Tropical Medicine
Study Sponsor Location:
United Kingdom
Funding Proposal:

Research Partner

Name of Partner Institution:
Action Against Hunger
Type of Organization:
NGO-international
Website:
www.actionaginsthunger.org
Location:
United States
Intervention

Intervention Overview

Intervention:
The intervention tested involves the nutritional treatment of malnourished children age 6-59 months with ready-to use therapeutic foods in Kenya and South Sudan. The control arm of the study will adhere to national protocols for the admission, case management and treatment of severe acute malnutrition using RUTF or moderate acute malnutrition using RUSF within the traditional OTP and SFP structures. The intervention arm will follow a combined, simplified protocol for the admission of acutely malnourished children based on mid upper arm circumference (MUAC), case management and treatment based on a reduced dosage of RUTF plumpy'nut. This will continue until discharge. The basic medical treatment of the children admitted with MUAC <115mm and/or bipedal oedema (+/++) on admission and/or weight for height z-score <-3 will be the same between the 2 groups and will follow the recommendations for the management of severe acute malnutrition as per the national protocols in Kenya and South Sudan. The objective is that the Combined Protocol using MUAC will improve coverage, quality, continuity, & cost effectiveness of acute malnutrition in resource constrained settings.
Theory of Change:
Multiple Treatment Arms Evaluated?
Yes

Implementing Agency

Name of Organization:
The International Rescue Committee and Action Against Hunger
Type of Organization:
NGO (local)/Community Based Organization/Other civil society organization

Program Funder

Name of Organization:
Children's Investment Fund Foundation (CIFF)
Type of Organization:
Private for profit organization

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
04/10/2017
End Date:
10/09/2017
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
Clusters (health facilities) will be matched (evenly distributed between control and intervention groups) according to the following factors, and then one from each pair will be randomly assigned to the intervention or control group: • Livelihoods • Major geographic constraints and/or facilitators (rivers, swamps, roads) • High or low patient load • High or low performing health facilities Once health facilities have been matched to account for the above factors, they will be randomized according to a computer-generated allocation sequence. The IRC in Kenya and ACF in South Sudan will use CommCare https://www.commcarehq.org/home/ to digitally collect all patient info on android tablets. All data will be captured both on paper and digitally, in order to allow for cross-checking of information.
Outcomes (Endpoints):
The primary outcome, ‘recovery’, in both the control and intervention groups will be defined as two consecutive measurements with a MUAC ?125mm and no oedema, is assessed by reviewing patient records at end of treatment. Secondary Outcomes: 1. Coverage, defined as % of children eligible for treatment (MUAC<125mm) who receive it, is measured using a SQUEAC survey at the end of the research enrolment period 2. Program default, defined by 2 consecutive missed visits in South Sudan or 3 consecutive missed visits in Kenya, is measured by reviewing patient records monthly for the duration of the 3. Program death rate is measured by reviewing patient records monthly for the duration of the 4. Length of stay in treatment is measured by reviewing patient records to determine the duration of treatment (days) until recover), at end of treatment 5. Average daily weight gain (g/kg/day) is measured by reviewing patient records at end of treatment 6. Average daily MUAC gain (mm/day) is measured by reviewing patient records at end of treatment
Measurement:
Unit of Analysis:
Middle Upper Arm Circumference (MUAC) in millimeters
Hypotheses:
1. The treatment of acute malnutrition using the Combined Protocol will be as effective as the standard protocol at recovering children from malnutrition as indicated by program exit status, length of stay, and average weekly weight and MUAC gain 2. Coverage of SAM and MAM treatment will increase under a Combined Protocol by improving early detection of MAM and preventing deterioration into SAM, and by improving program coherence and reducing loss during the transition from OTP to SFP
Unit of Intervention or Assignment:
Health Facilities
Number of Clusters in Sample:
12 clusters in each arm; total 24 clusters
Number of Individuals in Sample:
100 children in each cluster
Size of Treatment, Control, or Comparison Subsamples:
12 health facilities in each arm

Supplementary Files

Analysis Plan:
Other Documents:
Study Protocol for Global IRB Submission: ComPAS Study Protocol_Global_16 March.docx
Data

Outcomes Data

Description:
A Semi-quantitative evaluation of access and coverage (SQUEAC) will be conducted at the mid-point of the trial to assess coverage in each health facility catchment area. The SQUEAC methodology has been validated by the Coverage Monitoring Network (CMN) and is the preferred coverage assessment methodology for comparison across nutrition programs.
Data Already Collected?
No
Survey Name:
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: