TY - JOUR
T1 - Structured, multicomponent, community-based programme for women's health and infant health and development in rural Vietnam
T2 - a parallel-group cluster randomised controlled trial
AU - Fisher, Jane
AU - Tran, Thach
AU - Tran, Ha
AU - Luchters, Stanley
AU - Hipgrave, David B.
AU - Nguyen, Hau
AU - Tran, Thuy
AU - Hanieh, Sarah
AU - Simpson, Julie Anne
AU - Biggs, Beverley-Ann
AU - Tran, Tuan
N1 - Funding Information:
This research was funded by the Australian National Health and Medical Research Council (grant GNT1100147) and Grand Challenges Canada under the Saving Brains Initiative (seed funding 2014–15, and TTS-1803-22331). We are grateful to the Vietnam Ministry of Health's Department of Maternal and Child Health, in particular (post-humously) Nguyen Duc Vinh, and the Head of the Breastfeeding Unit, Nguyen Mai Huong, who reviewed all programme content to ensure that it aligned with national policies. We appreciate the efforts of the WHO Vietnam Office in ensuring alignment with relevant international policies and frameworks. We are also grateful to the HaNam Province Communist Party Peoples' Committee, the Provincial Centre for Disease Control, in particular Nguyen Thanh Duong, and the Deputy Directors of the Health Department, including Van That Pham and Truong Thanh Phong, who enabled implementation and made staff available to co-facilitate groups. The Vietnam National Women's Union provided exceptional support in enabling members to be trained and to serve as Learning Club facilitators. We appreciate the work of the Research and Training Centre for Community Development staff who oversaw implementation of the programme and conducted the facilitator training. We appreciate the work of the HaNam Provincial Centre for Disease Control, which collected the data, and the staff from the Green Pine Clinic, who conducted child development assessments. The work of the national and provincial trainers, and the community members who reviewed programme content was invaluable. We appreciate the expertise and time of the Data Safety Monitoring Board. Finally, we appreciate the time and commitment of all the facilitators and the participants.
Funding Information:
This research was funded by the Australian National Health and Medical Research Council (grant GNT1100147) and Grand Challenges Canada under the Saving Brains Initiative (seed funding 2014–15, and TTS-1803-22331). We are grateful to the Vietnam Ministry of Health's Department of Maternal and Child Health, in particular (post-humously) Nguyen Duc Vinh, and the Head of the Breastfeeding Unit, Nguyen Mai Huong, who reviewed all programme content to ensure that it aligned with national policies. We appreciate the efforts of the WHO Vietnam Office in ensuring alignment with relevant international policies and frameworks. We are also grateful to the HaNam Province Communist Party Peoples' Committee, the Provincial Centre for Disease Control, in particular Nguyen Thanh Duong, and the Deputy Directors of the Health Department, including Van That Pham and Truong Thanh Phong, who enabled implementation and made staff available to co-facilitate groups. The Vietnam National Women's Union provided exceptional support in enabling members to be trained and to serve as Learning Club facilitators. We appreciate the work of the Research and Training Centre for Community Development staff who oversaw implementation of the programme and conducted the facilitator training. We appreciate the work of the HaNam Provincial Centre for Disease Control, which collected the data, and the staff from the Green Pine Clinic, who conducted child development assessments. The work of the national and provincial trainers, and the community members who reviewed programme content was invaluable. We appreciate the expertise and time of the Data Safety Monitoring Board. Finally, we appreciate the time and commitment of all the facilitators and the participants.
Publisher Copyright:
© 2023 Elsevier Ltd
PY - 2023/5
Y1 - 2023/5
N2 - Background: Interventions to improve early childhood development have previously addressed only one or a few risk factors. Learning Clubs is a structured, facilitated, multicomponent programme designed to address eight potentially modifiable risk factors, and offered from mid-pregnancy to 12 months post partum; we aimed to establish whether this programme could improve the cognitive development of children at 2 years of age. Methods: For this parallel-group cluster-randomised controlled trial, 84 of 116 communes (the clustering unit) in HaNam Province in rural Vietnam were randomly selected and randomly assigned to receive the Learning Clubs intervention (n=42) or usual care (n=42). Women aged at least 18 years who were pregnant (gestational age <20 weeks) were eligible for inclusion. Data sources were standardised, and study-specific questionnaires assessing risks and outcomes were completed in interviews in mid-pregnancy (baseline), late pregnancy (after 32 weeks of gestation), at 6–12 months post partum, and at the end of the study period when children were 2 years of age. Mixed-effects models were used to estimate trial effects, adjusting for clustering. The primary outcome was the cognitive development of children at 2 years of age, assessed by the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) cognitive score. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000442303). Findings: Between April 28, 2018, and May 30, 2018, 1380 women were screened and 1245 were randomly assigned (669 to the intervention group and 576 to the control group). Data collection was completed on Jan 17, 2021. Data at the end of the study period were contributed by 616 (92%) of 669 women and their children in the intervention group, and by 544 (94%) of 576 women and their children in the control group. Children aged 2 years in the intervention group had significantly higher mean Bayley-III cognitive scores than those in the control group (99·6 [SD 9·7] vs 95·6 [9·4]; mean difference 4·00 [95% CI 2·56–5·43]; p<0·0001). At 2 years of age, 19 (3%) children in the intervention group had Bayley-III scores less than 1 SD, compared with 32 (6%) children in the control group, but this difference was not significant (odds ratio 0·55 [95% CI 0·26–1·17]; p=0·12). There were no significant differences between groups in maternal, fetal, newborn, or child deaths. Interpretation: A facilitated, structured, community-based, multicomponent group programme improved early childhood development to the standardised mean in rural Vietnam and could be implemented in other similarly resource-constrained settings. Funding: Australian National Health and Medical Research Council and Grand Challenges Canada Saving Brains Initiative. Translation: For the Vietnamese translation of the abstract see Supplementary Materials section.
AB - Background: Interventions to improve early childhood development have previously addressed only one or a few risk factors. Learning Clubs is a structured, facilitated, multicomponent programme designed to address eight potentially modifiable risk factors, and offered from mid-pregnancy to 12 months post partum; we aimed to establish whether this programme could improve the cognitive development of children at 2 years of age. Methods: For this parallel-group cluster-randomised controlled trial, 84 of 116 communes (the clustering unit) in HaNam Province in rural Vietnam were randomly selected and randomly assigned to receive the Learning Clubs intervention (n=42) or usual care (n=42). Women aged at least 18 years who were pregnant (gestational age <20 weeks) were eligible for inclusion. Data sources were standardised, and study-specific questionnaires assessing risks and outcomes were completed in interviews in mid-pregnancy (baseline), late pregnancy (after 32 weeks of gestation), at 6–12 months post partum, and at the end of the study period when children were 2 years of age. Mixed-effects models were used to estimate trial effects, adjusting for clustering. The primary outcome was the cognitive development of children at 2 years of age, assessed by the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III) cognitive score. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000442303). Findings: Between April 28, 2018, and May 30, 2018, 1380 women were screened and 1245 were randomly assigned (669 to the intervention group and 576 to the control group). Data collection was completed on Jan 17, 2021. Data at the end of the study period were contributed by 616 (92%) of 669 women and their children in the intervention group, and by 544 (94%) of 576 women and their children in the control group. Children aged 2 years in the intervention group had significantly higher mean Bayley-III cognitive scores than those in the control group (99·6 [SD 9·7] vs 95·6 [9·4]; mean difference 4·00 [95% CI 2·56–5·43]; p<0·0001). At 2 years of age, 19 (3%) children in the intervention group had Bayley-III scores less than 1 SD, compared with 32 (6%) children in the control group, but this difference was not significant (odds ratio 0·55 [95% CI 0·26–1·17]; p=0·12). There were no significant differences between groups in maternal, fetal, newborn, or child deaths. Interpretation: A facilitated, structured, community-based, multicomponent group programme improved early childhood development to the standardised mean in rural Vietnam and could be implemented in other similarly resource-constrained settings. Funding: Australian National Health and Medical Research Council and Grand Challenges Canada Saving Brains Initiative. Translation: For the Vietnamese translation of the abstract see Supplementary Materials section.
UR - http://www.scopus.com/inward/record.url?scp=85152248003&partnerID=8YFLogxK
U2 - 10.1016/S2352-4642(23)00032-9
DO - 10.1016/S2352-4642(23)00032-9
M3 - Article
C2 - 37011652
AN - SCOPUS:85152248003
SN - 2352-4642
VL - 7
SP - 311
EP - 325
JO - The Lancet Child & Adolescent Health
JF - The Lancet Child & Adolescent Health
IS - 5
ER -