Food supplementation and behavioral counseling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K'ASLEM hybrid type 1 effectiveness-implementation randomized controlled trial
- 1University of Michigan
Abstract
IntroductionAdults 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 analysisKASLEM is an individually randomized, 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 enroll 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) behavioral counseling to optimize 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 hemoglobin. 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 disseminationEthics 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 registrationThis trial was prospectively registered on ClinicalTrials.gov (NCT06750120).
Protocol versionVersion 3.0 (March 17, 2026).
KEY MESSAGESO_ST_ABSWhat is already known on this topicC_ST_ABSThe double burden of malnutrition, commonly defined at the household level as maternal overweight or obesity and child stunting in a mother-child dyad, occurs in more than 20% of households in some low- and middle-income countries. Inadequate nutrition during pregnancy, the postpartum period, and early childhood increases the lifelong risk of nutrition-related non-communicable diseases in both mother and child. Evidence-based interventions promote optimal maternal weight and child growth, but critical knowledge gaps remain in implementing them as integrated, sustainable, and accessible solutions among the worlds poorest.
What this study hopes to addThe KASLEM randomized controlled trial addresses these gaps by assessing an integrated intervention to reduce the double burden of malnutrition among pregnant and postpartum women and their children in Guatemala. The intervention consists of (1) food supplementation and (2) behavioral counseling to optimize maternal weight during pregnancy and the postpartum period and to promote healthy nutrition, physical activity, and infant feeding practices.
How this study might affect research, practice or policyThis study will generate evidence on the effectiveness, implementation, and cost-effectiveness of an integrated intervention to address the double burden of malnutrition, with implications for nutrition and non-communicable disease policy in Guatemala and other countries.
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BibTeX
@misc{flood2026food,
title = {{Food supplementation and behavioral counseling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K'ASLEM hybrid type 1 effectiveness-implementation randomized controlled trial}},
author = {D. Flood and M. Mazariegos and S. Hernandez Hidalgo and Y. Juarez Martin and W. A. Rodriguez Gomez and M. H. Moniz and C. Lu and A. C. Miller and M. Ramirez-Zea and P. Rohloff},
howpublished = {medRxiv},
year = {2026},
month = sep,
doi = {10.64898/2026.09.08.26362539},
url = {https://www.medrxiv.org/content/10.64898/2026.09.08.26362539v1},
note = {CC BY-NC},
}
RIS
TY - UNPB
TI - Food supplementation and behavioral counseling to reduce the double burden of malnutrition among pregnant women and their infants: protocol for the K'ASLEM hybrid type 1 effectiveness-implementation randomized controlled trial
AU - D. Flood
AU - M. Mazariegos
AU - S. Hernandez Hidalgo
AU - Y. Juarez Martin
AU - W. A. Rodriguez Gomez
AU - M. H. Moniz
AU - C. Lu
AU - A. C. Miller
AU - M. Ramirez-Zea
AU - P. Rohloff
PY - 2026
DA - 2026/09/08
PB - medRxiv
DO - 10.64898/2026.09.08.26362539
UR - https://www.medrxiv.org/content/10.64898/2026.09.08.26362539v1
AB - IntroductionAdults 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 analysisKASLEM is an individually randomized, 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 enroll 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) behavioral counseling to optimize 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 hemoglobin. 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 disseminationEthics 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 registrationThis trial was prospectively registered on ClinicalTrials.gov (NCT06750120). Protocol versionVersion 3.0 (March 17, 2026). KEY MESSAGESO_ST_ABSWhat is already known on this topicC_ST_ABSThe double burden of malnutrition, commonly defined at the household level as maternal overweight or obesity and child stunting in a mother-child dyad, occurs in more than 20% of households in some low- and middle-income countries. Inadequate nutrition during pregnancy, the postpartum period, and early childhood increases the lifelong risk of nutrition-related non-communicable diseases in both mother and child. Evidence-based interventions promote optimal maternal weight and child growth, but critical knowledge gaps remain in implementing them as integrated, sustainable, and accessible solutions among the worlds poorest. What this study hopes to addThe KASLEM randomized controlled trial addresses these gaps by assessing an integrated intervention to reduce the double burden of malnutrition among pregnant and postpartum women and their children in Guatemala. The intervention consists of (1) food supplementation and (2) behavioral counseling to optimize maternal weight during pregnancy and the postpartum period and to promote healthy nutrition, physical activity, and infant feeding practices. How this study might affect research, practice or policyThis study will generate evidence on the effectiveness, implementation, and cost-effectiveness of an integrated intervention to address the double burden of malnutrition, with implications for nutrition and non-communicable disease policy in Guatemala and other countries.
ER -