Effect of an innovative behavioural change strategy and small-quantity lipid-based nutrient supplements on stunting and obesity in children in Baja Verapaz, Guatemala: protocol for a randomised control trial.

INTRODUCTION

In Latin America, a rapid increase in obesity alongside persistent malnutrition has resulted in a double burden of disease that affects the most vulnerable segments of the population. Infant and young child feeding practices are important factors that affect both sides of the growth curve. Interventions such as behavioural change strategies and home fortification using products like small-quantity lipid-based nutrient supplements (SQ-LNS) have the potential to reduce the presence of both these conditions, especially if they are implemented during the first 1000 days of life. This paper details the protocol for Sustained Programme for Improving Nutrition (SPOON), an innovative strategy to prevent stunting and reduce risk for obesity in children under 24 months old in high-poverty areas in Baja Verapaz, Guatemala.

METHODS AND ANALYSIS

SPOON Guatemala is a three-arm randomised control trial: treatment group 1 will receive the SPOON behavioural change strategy and SQ-LNS, treatment group 2 will receive the SPOON behavioural change strategy and micronutrient powders; the control group will receive the standard of care provided by the Ministry of Health, which includes micronutrient powders. A modified formula of SQ-LNS has been especially developed for this trial. A total of 76 communities are included in the study and 1628 households with a pregnant woman in the third trimester or a child under 4.5 months were recruited at baseline. Baseline data were collected between September and November 2018. Follow-up data will be collected 2 years after the start of the intervention. The primary outcomes of interest are related to mothers' infant feeding knowledge and practice, and indicators of children's nutritional status and growth including height, weight, weight gain rate and prevalence of stunting, overweight, obesity and anaemia. After follow-up data have been collected, differences of simple means and regression models including covariates such as child's age and sex, characteristics of the primary caregiver and household socioeconomic indicators will be estimated. Heterogeneous effects will also be estimated within subgroups of age at exposure, sex, caregiver characteristics and household socioeconomic status.

ETHICS AND DISSEMINATION

This study was approved by the National Health Ethics Committee of the Ministry of Health of Guatemala (resolution 10-2018). Informed consent was obtained from all mothers and caregivers prior to enrolment in the programme. Results will be submitted to a peer-reviewed medical or public health journal, and disseminated internally at the Inter-American Development Bank, with the Government and Stakeholders in Guatemala and through international conferences and seminars.

TRIAL REGISTRATION NUMBER

NCT03399617.