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

NCT03967015 | Unknown DMC

• 1 other identifier: STUDY00006221
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 3

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.

Conditions

Child Malnutrition

Keywords

Mobile Health; Kenya; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (13)

• 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

  4 months

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

  6 months

• Mean change in MUAC between baseline and outcome assessment

  6 months

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

  6 months

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

  6 months

Study Arms (2)

Maternal Administered Malnutrition Monitoring System (MAMMS)

EXPERIMENTAL

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.

Other: Maternal Administered Malnutrition Monitoring System (MAMMS)

Standard of care (SOC)

NO INTERVENTION

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.

Interventions

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.

Maternal Administered Malnutrition Monitoring System (MAMMS)

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (3)

Homa Bay County Referral Hospital

Homa Bay, Kenya

NOT YET RECRUITING

Nyatike (Macalder) Sub-County Hospital

Macalder, Kenya

RECRUITING

Migori County Referral Hospital

Migori, Kenya

RECRUITING

Related Publications (2)

• 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.

  PMID: 37781159 DERIVED

• 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.

  PMID: 32963066 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Christine J McGrath, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirkby D Tickell, MBBS, MPH

CONTACT

206-543-4278; kirkbt@uw.edu

Christine J McGrath, PhD, MPH

CONTACT

206-543-4278; mcgrathc@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Public Health, Global Health

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 29, 2019
• Study Start: August 2, 2019
• Primary Completion: August 2, 2021
• Study Completion: February 3, 2022
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD that underlie results in a publication will be made publicly available within 6 months of the publication.
• 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.

Locations

KE (3)