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Child MalnutritionNCT03967015

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

A study testing Maternal Administered Malnutrition Monitoring System (MAMMS) in people with Child Malnutrition, run by University of Washington at 3 sites in Kenya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 monthsHealthy volunteers can take part
Conditions the study is for
Child Malnutrition
What is being tested?
Maternal Administered Malnutrition Monitoring System (MAMMS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
3 sitesKenya
Study dates
2 Aug 2019to 3 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Kirkby D Tickell, MBBS, MPH contact

206-543-4278

kirkbt@uw.edu

Christine J McGrath, PhD, MPH contact

206-543-4278

mcgrathc@uw.edu

Kenya3 sites, 3 recruiting
  • Homa Bay County Referral Hospital

    Homa Bay

    Benson Singa, MBChB, MPH

    Not yet recruiting
  • Nyatike (Macalder) Sub-County Hospital

    Macalder

    Benson Singa, MBChB, MPH

    Recruiting
  • Migori County Referral Hospital

    Migori

    Benson Singa, MBChB, MPH

    Recruiting

Other trials in Kenya

About this study

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.

Read the 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.

Being tested
Maternal Administered Malnutrition Monitoring System (MAMMS)
Keywords
Mobile Health, Kenya, Randomized Controlled Trial
Medical subject headings
Child Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maternal Administered Malnutrition Monitoring System (MAMMS)Other

    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.

Study groups in NCT03967015
Study groupRoleWhat they receive
Maternal Administered Malnutrition Monitoring System (MAMMS)ExperimentalParticipants 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.
Receives: Other: Maternal Administered Malnutrition Monitoring System (MAMMS)
Standard of care (SOC)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 months

Secondary outcomes (13)
  1. 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

    Measured: 4 months

  2. Mean difference in participant and field worker MUAC measures between baseline and outcome assessment

    Measured: 6 months

  3. Mean change in MUAC between baseline and outcome assessment

    Measured: 6 months

  4. Proportion of participants in the MAMMS arm that report continued interest in participation in the MAMMS intervention at outcome assessment

    Measured: 6 months

  5. Proportion of delivered short message service (SMS) messages that the participant responds to

    Measured: 6 months

  6. Proportion of delivered short message service (SMS) messages that the participant responds to by mobile phone ownership

    Measured: 6 months

  7. Proportion of delivered short message service (SMS) messages that the participant responds to by participant literacy

    Measured: 6 months

  8. Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment

    Measured: 6 months

  9. 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

    Measured: 6 months

  10. Mean change in the number of delivered short message service (SMS) messages that the participant responds between baseline and outcome assessment by participant literacy

    Measured: 6 months

  11. Mean unit cost per child identified with acute malnutrition (MUAC<12.5cm) following randomization

    Measured: 6 months

  12. Mean incremental total costs (economic and financial costs) per child identified with acute malnutrition (MUAC<12.5cm) following randomization

    Measured: 6 months

  13. Mean unit cost per child treated for acute malnutrition among those identified with acute malnutrition (MUAC<12.5cm) following randomization

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2019
  2. Study start2 Aug 2019
  3. Primary completion2 Aug 2021 (estimated)
  4. Study completion3 Feb 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03967015
Sponsor's protocol ID
STUDY00006221
Status last verified
Jan 2020
First submitted
13 May 2019
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD that underlie results in a publication will be shared with other researchers.

Publications

  • Tickell KD, Achieng C, Masheti M, Anyango M, Ndirangu A, Diakhate MM, Yoshioka E, Levin C, Rubin Means A, Choo EM, Ronen K, Unger JA, Richardson BA, Singa BO, McGrath CJ. Family MUAC supported by a two-way SMS platform for identifying children with wasting: the Mama Aweza randomised controlled trial. EClinicalMedicine. 2023 Sep 21;64:102218. doi: 10.1016/j.eclinm.2023.102218. eCollection 2023 Oct.

    PubMed 37781159
  • 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.

    PubMed 32963066

Questions about this trial

What is this clinical trial studying?

A study testing Maternal Administered Malnutrition Monitoring System (MAMMS) in people with Child Malnutrition, run by University of Washington at 3 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kirkby D Tickell, MBBS, MPH (206-543-4278, kirkbt@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to diagnosis of acute malnutrition [mid-upper arm circumference (MUAC) <12.5cm] following randomization (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03967015, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

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