Food supplementation and behavioural counselling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K’ASLEM hybrid type 1 effectiveness-implementation randomised controlled trial
6 affiliations
- 1Department of Medicine, University of Michigan, Ann Arbor, MI, USA
- 2INCAP Research Center for the Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala
- 3Center for Indigenous Health Research, Wuqu' Kawoq, Tecpán, Guatemala
- 4Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan, USA
- 5Division of Global Health Equity, Brigham and Women’s Hospital, Boston, Massachusetts, USA
- 6Department of Global Health and Social Medicine, Blavatnik Institute, Harvard Medical School, Boston, Massachusetts, USA
Abstract
Introduction: Adults globally are experiencing increases in diseases attributable to overnutrition, yet child undernutrition persists at high levels. This ‘double burden of malnutrition’ increases the risk of nutrition-related non-communicable diseases in mother and child. Evidence-based interventions promote optimal maternal weight or child growth, but gaps remain in implementing them as integrated, sustainable and equity-focused solutions.
Methods and analysis: K’ASLEM is an individually randomised, parallel-group Hybrid Type 1 effectiveness-implementation trial in Indigenous Maya communities in Guatemala with high levels of the double burden of malnutrition. We will enrol 766 pregnant women aged ≥16 years at less than 28 weeks’ gestation, allocated 1:1 to intervention or comparator. The intervention integrates (a) food supplementation for pregnant and postpartum mothers and their infants and (b) behavioural counselling to optimise maternal weight and promote healthy nutrition, physical activity and infant feeding practices. The comparator is enhanced usual care. Mother-child dyads will be followed until 12 months after birth. Co-primary outcomes are maternal weight and child length-for-age z-score at 12 months. Secondary outcomes are child stunting, child development, maternal overweight or obesity, and maternal haemoglobin. We will collect quantitative and qualitative implementation data, use Implementation Mapping to identify factors shaping implementation, and conduct an economic evaluation of costs and cost-effectiveness.
Ethics and dissemination: Ethics approval was obtained from the Institutional Review Boards of Mass General Brigham and Maya Health Alliance and the Institute of Nutrition of Central America and Panama Research Ethics Committee. Results will be published in peer-reviewed, open-access journals.
Trial registration number: NCT06750120.
Protocol version: Version 3.0 (17 March 2026).
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BibTeX
@article{flood2026food,
title = {{Food supplementation and behavioural counselling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K’ASLEM hybrid type 1 effectiveness-implementation randomised controlled trial}},
author = {David Flood and Monica Mazariegos and Sara Hernández Hidalgo and Yolanda Juárez Martín and Wendy Azucena Rodríguez Gómez and Michelle H Moniz and Chunling Lu and Ann C Miller and Manuel Ramírez-Zea and Peter Rohloff},
journal = {BMJ Paediatrics Open},
year = {2026},
month = oct,
doi = {10.1136/bmjpo-2026-005165},
url = {https://doi.org/10.1136/bmjpo-2026-005165},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Food supplementation and behavioural counselling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K’ASLEM hybrid type 1 effectiveness-implementation randomised controlled trial
AU - David Flood
AU - Monica Mazariegos
AU - Sara Hernández Hidalgo
AU - Yolanda Juárez Martín
AU - Wendy Azucena Rodríguez Gómez
AU - Michelle H Moniz
AU - Chunling Lu
AU - Ann C Miller
AU - Manuel Ramírez-Zea
AU - Peter Rohloff
PY - 2026
DA - 2026/10/27
JO - BMJ Paediatrics Open
DO - 10.1136/bmjpo-2026-005165
UR - https://doi.org/10.1136/bmjpo-2026-005165
AB - Introduction: Adults globally are experiencing increases in diseases attributable to overnutrition, yet child undernutrition persists at high levels. This ‘double burden of malnutrition’ increases the risk of nutrition-related non-communicable diseases in mother and child. Evidence-based interventions promote optimal maternal weight or child growth, but gaps remain in implementing them as integrated, sustainable and equity-focused solutions. Methods and analysis: K’ASLEM is an individually randomised, parallel-group Hybrid Type 1 effectiveness-implementation trial in Indigenous Maya communities in Guatemala with high levels of the double burden of malnutrition. We will enrol 766 pregnant women aged ≥16 years at less than 28 weeks’ gestation, allocated 1:1 to intervention or comparator. The intervention integrates (a) food supplementation for pregnant and postpartum mothers and their infants and (b) behavioural counselling to optimise maternal weight and promote healthy nutrition, physical activity and infant feeding practices. The comparator is enhanced usual care. Mother-child dyads will be followed until 12 months after birth. Co-primary outcomes are maternal weight and child length-for-age z-score at 12 months. Secondary outcomes are child stunting, child development, maternal overweight or obesity, and maternal haemoglobin. We will collect quantitative and qualitative implementation data, use Implementation Mapping to identify factors shaping implementation, and conduct an economic evaluation of costs and cost-effectiveness. Ethics and dissemination: Ethics approval was obtained from the Institutional Review Boards of Mass General Brigham and Maya Health Alliance and the Institute of Nutrition of Central America and Panama Research Ethics Committee. Results will be published in peer-reviewed, open-access journals. Trial registration number: NCT06750120. Protocol version: Version 3.0 (17 March 2026).
SN - 2399-9772
ER -