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Developing Low-Cost Universal Malnutrition Screening for Low Income Countries - the MAMMS Trial

Primary Purpose

Child Malnutrition

Status
Unknown status
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Maternal Administered Malnutrition Monitoring System (MAMMS)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Child Malnutrition focused on measuring Mobile Health, Kenya, Randomized Controlled Trial

Eligibility Criteria

6 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Infant is 6-12 months of age and MUAC of 12.5-14.0 cm
  • Access to a mobile phone and can provide a mobile phone number
  • Planning to remain in the catchment area more than 6 months and willing to return for 6-month follow up visit
  • Mother is willing to be randomized to weekly SMS and measure and send weekly infant MUAC via SMS
  • Able to read or write or has someone to help them read or write

Exclusion Criteria:

  • Infant is currently on treatment for malnutrition
  • Inability to provide a mobile phone number
  • Mothers that could not read or write and did not have someone to help them read or write

Sites / Locations

  • Homa Bay County Referral Hospital
  • Nyatike (Macalder) Sub-County HospitalRecruiting
  • Migori County Referral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Maternal Administered Malnutrition Monitoring System (MAMMS)

Standard of care (SOC)

Arm Description

Participants randomized to the MAMMS arm will receive MUAC training and nutritional education at enrollment. A short message service (SMS) message will be sent at 7 days following enrollment asking them to measure and send their child's MUAC. Weekly SMS messages asking for the child's MUAC measurement will be sent every 7 days until the last study visit at 180 days following enrollment.

Participants randomized to the standard of care (SOC) arm will receive the same MUAC training and nutritional education as mothers in the MAMMS arm. To accurately simulate community malnutrition outreach programs, no SMS message will be sent to participants in this arm.

Outcomes

Primary Outcome Measures

Time to diagnosis of acute malnutrition [mid-upper arm circumference (MUAC) <12.5cm] following randomization

Secondary Outcome Measures

Number of children who recover from acute malnutrition (no death, no hospitalization, weight-for-length z-score>-2 and/or MUAC≥12.5cm) among those identified with acute malnutrition (MUAC<12.5cm) following randomization
Mean difference in participant and field worker MUAC measures between baseline and outcome assessment
Mean change in MUAC between baseline and outcome assessment
Proportion of participants in the MAMMS arm that report continued interest in participation in the MAMMS intervention at outcome assessment
Proportion of delivered short message service (SMS) messages that the participant responds to
Proportion of delivered short message service (SMS) messages that the participant responds to by mobile phone ownership
Proportion of delivered short message service (SMS) messages that the participant responds to by participant literacy
Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment
Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment by mobile phone ownership
Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment by participant literacy
Mean unit cost per child identified with acute malnutrition (MUAC<12.5cm) following randomization
Mean incremental total costs (economic and financial costs) per child identified with acute malnutrition (MUAC<12.5cm) following randomization
Mean unit cost per child treated for acute malnutrition among those identified with acute malnutrition (MUAC<12.5cm) following randomization

Full Information

First Posted
May 13, 2019
Last Updated
January 8, 2020
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03967015
Brief Title
Developing Low-Cost Universal Malnutrition Screening for Low Income Countries - the MAMMS Trial
Official Title
Developing Low-Cost Universal Malnutrition Screening for Low Income Countries - the MAMMS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
August 2, 2021 (Anticipated)
Study Completion Date
February 3, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute malnutrition affects 52 million children, costs $2.1 trillion globally, and contributes to 45% of deaths among children under five years of age. Affordable home-based treatments can prevent many of these deaths, with success rates over 97.5% if malnutrition is identified early. If identified late, treatment failure rates increase to 16%. Malnutrition programs currently rely on community health volunteers to screen children, which can lead to high costs, low screening coverage, and late identification. Mid upper arm circumference (MUAC) is the preferred community malnutrition screening tool. Training mothers to use MUAC tapes to monitor their child's nutritional status through a short message service (SMS) mobile health system could increase screening coverage and facilitate rapid engagement with nutritional services where necessary. The investigators propose to test the "Maternal Administered Malnutrition Monitoring System" (MAMMS) in a randomized controlled trial in Kenya. Participants will be taught to measure their child's MUAC at 6 or 9-month immunization visits and during 6-month follow up the participants will receive a weekly SMS prompting them to measure and send their child's MUAC to a computer system which will alert a health worker when a child with malnutrition is identified. This scalable system could enable nutrition programs to optimize screening coverage, leading to early identification of malnutrition, lower costs and a reduction in under-five mortality.
Detailed Description
Acute malnutrition is a critical driver of pediatric mortality that must be addressed to achieve global child health targets. Provision of ready-to-use therapeutic foods (RUTF) and nutritional counselling in the community is a highly effective method of preventing deaths among malnourished children. However, UNICEF estimates that only 17% of malnourished children receive treatment. Among children who are treated, the diagnosis of acute malnutrition is often made late in their disease when the risk of complications and death increases from 2.5% to 16%. Increasing the coverage and frequency of nutritional screening to identify malnourished children earlier in the disease process is a critical step toward achieving global child health goals. Mid-upper arm circumference (MUAC) is the preferred community malnutrition screening tool. Recent evidence comparing MUAC measurements taken by mothers and community health workers showed that mothers can accurately measure their child's MUAC and identify malnutrition. Yet, there is no pragmatic method of linking these mothers to the nutritional care that malnourished children require. Training and supporting mothers to use MUAC tapes to monitor their child's nutritional status through a two-way short message service (SMS) mobile health system could dramatically increase the coverage of malnutrition screening and facilitate rapid engagement with nutritional service where necessary. This randomized controlled trial will test the "Maternal Administered Malnutrition Monitoring System" (MAMMS) in western Kenya. Participants will be taught to measure their child's MUAC at 6 or 9-month immunization visits and during 6-month follow up participants will receive weekly SMS messages prompting them to measure and send their child's MUAC to a computer system which will alert a health worker when a child with malnutrition is identified. This scalable childhood growth monitoring system could enable nutrition programs in low and middle income countries to optimize screening coverage, leading to early identification of malnutrition, lower costs and a reduction in global under-five mortality. The study aims to: Aim 1: Determine if MAMMS leads to earlier identification and recovery from acute malnutrition (MUAC <12.5cm). Hypothesis 1.1: Children randomized to MAMMS who develop acute malnutrition will be identified earlier than children in the control arm. Hypothesis 1.2: Children randomized to MAMMS who develop acute malnutrition will be more likely to successfully complete nutritional rehabilitation (defined as no death, no hospitalization, no severe acute malnutrition, and resolution of moderate malnutrition within 4 months of diagnosis) than children in the control arm diagnosed with acute malnutrition. Aim 2: Demonstrate the accuracy of maternal administered MUAC assessments compared to trained community health worker, and the ability of repeated maternal administered MUAC measurements to monitor early childhood growth. Hypothesis 2.1: Maternally measured MUAC will be strongly correlated with health worker measured MUAC at baseline and during follow-up. Hypothesis 2.2: A highly sensitive and specific growth trajectory that predicts moderate acute malnutrition can be identified using maternally measured MUAC. Aim 3: Evaluate the acceptability, feasibility, fidelity and cost per-child-treated of MAMMS relative to standard-of-care nutrition programs. Hypothesis 3.1: MAMMS will be acceptable and feasible to mothers and health workers. Hypothesis 3.2: MAMMS will have a substantially lower cost-per-malnutrition case identified than standard screening approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Malnutrition
Keywords
Mobile Health, Kenya, Randomized Controlled Trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maternal Administered Malnutrition Monitoring System (MAMMS)
Arm Type
Experimental
Arm Description
Participants randomized to the MAMMS arm will receive MUAC training and nutritional education at enrollment. A short message service (SMS) message will be sent at 7 days following enrollment asking them to measure and send their child's MUAC. Weekly SMS messages asking for the child's MUAC measurement will be sent every 7 days until the last study visit at 180 days following enrollment.
Arm Title
Standard of care (SOC)
Arm Type
No Intervention
Arm Description
Participants randomized to the standard of care (SOC) arm will receive the same MUAC training and nutritional education as mothers in the MAMMS arm. To accurately simulate community malnutrition outreach programs, no SMS message will be sent to participants in this arm.
Intervention Type
Other
Intervention Name(s)
Maternal Administered Malnutrition Monitoring System (MAMMS)
Intervention Description
Participants randomized to the MAMMS arm will be provided with two insertion MUAC tapes that are UNICEF color coded and numbered to 1 mm gradations to take home with them. Participants will receive a weekly SMS asking them to measure and send their child's MUAC via SMS. SMS messages will provide actionable reminders to measure and send the child's MUAC. Both the SMS sent to the participant and SMS responses sent by the participant to the MAMMS system will be free of charge. Study staff will screen all SMS measurements returned to the MUAC system for identification of malnutrition.
Primary Outcome Measure Information:
Title
Time to diagnosis of acute malnutrition [mid-upper arm circumference (MUAC) <12.5cm] following randomization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of children who recover from acute malnutrition (no death, no hospitalization, weight-for-length z-score>-2 and/or MUAC≥12.5cm) among those identified with acute malnutrition (MUAC<12.5cm) following randomization
Time Frame
4 months
Title
Mean difference in participant and field worker MUAC measures between baseline and outcome assessment
Time Frame
6 months
Title
Mean change in MUAC between baseline and outcome assessment
Time Frame
6 months
Title
Proportion of participants in the MAMMS arm that report continued interest in participation in the MAMMS intervention at outcome assessment
Time Frame
6 months
Title
Proportion of delivered short message service (SMS) messages that the participant responds to
Time Frame
6 months
Title
Proportion of delivered short message service (SMS) messages that the participant responds to by mobile phone ownership
Time Frame
6 months
Title
Proportion of delivered short message service (SMS) messages that the participant responds to by participant literacy
Time Frame
6 months
Title
Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment
Time Frame
6 months
Title
Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment by mobile phone ownership
Time Frame
6 months
Title
Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment by participant literacy
Time Frame
6 months
Title
Mean unit cost per child identified with acute malnutrition (MUAC<12.5cm) following randomization
Time Frame
6 months
Title
Mean incremental total costs (economic and financial costs) per child identified with acute malnutrition (MUAC<12.5cm) following randomization
Time Frame
6 months
Title
Mean unit cost per child treated for acute malnutrition among those identified with acute malnutrition (MUAC<12.5cm) following randomization
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infant is 6-12 months of age and MUAC of 12.5-14.0 cm Access to a mobile phone and can provide a mobile phone number Planning to remain in the catchment area more than 6 months and willing to return for 6-month follow up visit Mother is willing to be randomized to weekly SMS and measure and send weekly infant MUAC via SMS Able to read or write or has someone to help them read or write Exclusion Criteria: Infant is currently on treatment for malnutrition Inability to provide a mobile phone number Mothers that could not read or write and did not have someone to help them read or write
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kirkby D Tickell, MBBS, MPH
Phone
206-543-4278
Email
kirkbt@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine J McGrath, PhD, MPH
Phone
206-543-4278
Email
mcgrathc@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine J McGrath, PhD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Homa Bay County Referral Hospital
City
Homa Bay
Country
Kenya
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benson Singa, MBChB, MPH
Facility Name
Nyatike (Macalder) Sub-County Hospital
City
Macalder
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benson Singa, MBChB, MPH
Facility Name
Migori County Referral Hospital
City
Migori
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benson Singa, MBChB, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD that underlie results in a publication will be shared with other researchers.
IPD Sharing Time Frame
IPD that underlie results in a publication will be made publicly available within 6 months of the publication.
IPD Sharing Access Criteria
IPD that underlie results in a publication will be made publicly available in an open access repository within 6 months of the publication.
Citations:
PubMed Identifier
32963066
Citation
Tickell KD, Diakhate MM, Goodman JL, Unger JA, Richardson BA, Rubin Means A, Ronen K, Levin C, Choo EM, Achieng C, Masheti M, Singa BO, McGrath CJ. Impact of a two-way short message service (SMS) to support maternally administered childhood mid-upper arm circumference monitoring and expand malnutrition screening in Kenya: the Mama Aweza trial protocol. BMJ Open. 2020 Sep 22;10(9):e036660. doi: 10.1136/bmjopen-2019-036660.
Results Reference
derived

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Developing Low-Cost Universal Malnutrition Screening for Low Income Countries - the MAMMS Trial

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