Objective Stunting is a common cause of early child developmental delay; Guatemala has the fourth highest rate of stunting globally. The goal of this study was to examine the impact of an intensive community health worker-led complementary feeding intervention on early child development in Guatemala. We hypothesised that the intervention would improve child development over usual care.
Design A substudy from a larger individually randomised (1:1 allocation ratio), parallel-group superiority trial, with blinding of study staff collecting outcomes data.
Setting Rural, indigenous Maya communities in Guatemala.
Participants 210 stunted children (height-for-age z-score ≤−2.5) aged 6–24 months, previously randomised to usual care (106) or an intensive complementary feeding intervention (104). 84 in the intervention and 91 in the usual care arm agreed to participate.
Interventions Community health workers conducted monthly home visits for 6 months, providing usual care or individualised complementary feeding education.
Main outcome measures The primary outcomes were change in z-scores for the subscales of the Bayley Scales of Infant Development (BSID), Third Edition.
Results 100 individuals were included in the final analysis, 47 in the intervention and 53 in the usual care arm. No statistically significant differences in age-adjusted scores between the arms were observed for any subscale. However, improvements within-subjects in both arms were observed (median duration between measurements 189 days (IQR 182–189)). Mean change for subscales was 0.45 (95% CI 0.23 to 0.67) z-scores in the intervention, and 0.43 (95% CI 0.25 to 0.61) in the usual care arm.
Conclusions An intensive complementary feeding intervention did not significantly improve developmental outcomes more than usual care in stunted, indigenous Guatemalan children. However, both interventions had significant positive impacts on developmental outcomes.
Trial registration number NCT02509936.
- early child development
- randomized clinical trial
- community health workers
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Contributors BM supervised the study, analysed and interpreted data and produced the first manuscript draft. SC cured, analysed and interpreted data. PR, ML, AG collected data and supervised BSID-III data collection. MFW and MPG supervised the study and cultural adaptation for the BSID-III. MPG and PR designed and supervised the study. No individual was given any form of payment to produce the article. All authors critically revised the manuscript and made substantial contributions to the final draft.
Funding This work was supported by Grand Challenges Canada, grant number SB-1726251050.
Disclaimer The study sponsor had no role in study design; the collection, analysis and interpretation of data; the writing of the report and the decision to submit the paper for publication.
Competing interests BM, MFW and PR are employees or volunteers at Wuqu’ Kawoq, Maya Health Alliance, the non-governmental organisation that provided logistical support for this study in Guatemala. SC, PR, ML, AG and MPG are doctoral students or employees of Universidad del Valle de Guatemala. The authors declare no other relationships or activities that could have influenced the submitted work.
Patient consent Not required.
Ethics approval Institutional Review Boards of the Universidad del Valle de Guatemala and Maya Health Alliance.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Study protocol, replication dataset and statistical code are available on publication at: https://doi.org/10.7910/DVN/ATJ3NW.
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