NCT Number: NCT07490899
This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.
Trial opening soon.
Get Notified6 month–30 month
All sexes
Interventional
Phase 3
Plan International, Kakata, Liberia
The BUNDLE study will examine the effects of a 7-month nutrition and caregiving intervention for female and male caregivers delivered by trained adult community facilitators in rural communities across Liberia. The study will use a four-arm 2x2 factorial cluster randomized design to test the effectiveness of the interventions on primary outcomes of child cognitive, language, motor, and socio-emotional development. In this study, 2240 children aged 6 to 30 months will be recruited from 160 rural communities randomized to a comparison arm or one of the three intervention arms. The comparison arm will receive the local standard of care. Three intervention arms will also receive either a responsive stimulation intervention with female and male caregivers, provision of eggs and dried fish accompanied by nutrition education, or responsive stimulation + provision of eggs and dried fish. We hypothesize that child development will be improved in all intervention arms compared to the comparison arm and in the combined intervention arm compared to the single intervention arms.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Caregiving-related social and behavior change (SBC) messages and activities for primary female and secondary (male or female) caregivers focused on responsive stimulation, encompassing responsive caregiver-child interactions and the provision of early learning opportunities.
Provision of eggs and dried Bonny fish. Nutrition-related social and behavior change (SBC) messages focused on infant and young child feeding (IYCF), the importance of feeding the child eggs and dried fish, and ways to feed these foods to the child.
Time frame: 7 months
Change from baseline to end-line in cognitive composite score on Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 162 with higher scores representing higher cognitive development.
Time frame: 7 months
Change from baseline to end-line in language composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 158 with higher scores representing higher language development.
Time frame: 7 months
Change from baseline to end-line in motor composite score on the Bayley Scale of Infant and Toddler Development, 4th Edition. Raw scores range from 0 to 208 with higher scores representing higher motor development.
Time frame: 7 months
Change from baseline to end-line in socio-emotional score on the Wolke Behavior Rating scale. Scores range from 9 to 81 with higher scores representing higher socio-emotional development.
Time frame: 7 months
Change from baseline to end-line in child height or length-for-age z-score.
Time frame: 7 months
Change from baseline to end-line in child weight-for-age z-score.
Time frame: 7 months
Change from baseline to end-line in child weight-for-height (or length) z-score.
Time frame: 7 months
Change from baseline to end-line in percent children consuming at least 3 eggs in the past week
Time frame: 7 months
Change from baseline to end-line in percent children consuming at least 1 piece of fish in the past week
Time frame: 7 months
Change from baseline to end-line in child dietary diversity score defined as number of food groups out of a total of eight food groups consumed in the previous 7 days based on World Health Organization guidelines and is assessed in children aged six months or older.
Time frame: 7 months
Change from baseline to end-line in responsive feeding score assessed using the responsive feeding assessment. Scores range from 8 to 32 with higher scores representing higher responsive feeding behaviors.
Time frame: 7 months
Change from baseline to end-line in early learning opportunities score assessed using the Tool for Early learning. Scores range from 0 to 14 with higher scores representing more opportunities for early learning.
Time frame: 7 months
Change from baseline to end-line in primary female caregiver perceived social support assessed using the Multidimensional Scale of Perceived Social Support. Scores range from 12 to 84 with higher scores representing higher social support.
Time frame: 7 months
Change from baseline to end-line in proportion of responsive interactions between the primary female caregiver and child assessed using the Tool for Responsive Care.
Time frame: 7 months
Change from baseline to end-line in proportion of responsive interactions between the male caregiver and child assessed using the Tool for Responsive Care.
Time frame: 7 months
Change from baseline to end-line in proportion of responsive interactions between the secondary female caregiver and child assessed using the Tool for Responsive Care.
Time frame: 7 months
Change from baseline to end-line in the primary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms.
Time frame: 7 months
Change from baseline to end-line in the male caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms.
Time frame: 7 months
Change from baseline to end-line in the secondary female caregiver depression score assessed using the Patient Health Questionnaire-9. Scores range from 0 to 27 with higher scores representing higher depressive symptoms.
Time frame: 7 months
Change from baseline to end-line in the primary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety.
Time frame: 7 months
Change from baseline to end-line in the male caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety.
Time frame: 7 months
Change from baseline to end-line in the secondary female caregiver anxiety score assessed using the General Anxiety Disorder-7 Questionnaire. Scores range from 0 to 21 with higher scores representing higher anxiety.
Time frame: 7 months
Change from baseline to end-line in the primary caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health.
Time frame: 7 months
Change from baseline to end-line in the male caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health.
Time frame: 7 months
Change from baseline to end-line in the secondary female caregiver positive mental health score assessed using the Mental Health Continuum-Short Form. Scores range from 14 to 84 with higher scores representing poorer mental health.
Time frame: 7 months
Change from baseline to end-line in the primary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress.
Time frame: 7 months
Change from baseline to end-line in the male caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress.
Time frame: 7 months
Change from baseline to end-line in the secondary female caregiver perceived stress score assessed using the Parenting Stress Index. Scores range from 36 to 147 with higher scores representing higher stress.
Time frame: 7 months
Change from baseline to end-line in the primary female co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting.
Time frame: 7 months
Change from baseline to end-line in the male caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting.
Time frame: 7 months
Change from baseline to end-line in the secondary female caregiver co-parenting score assessed using the brief Coparenting Relationship Scale. Scores range from 0 to 84 with higher scores representing more positive coparenting.
Time frame: 7 months
Change from baseline to end-line in percent children with at least one diarrheal episode in the past two weeks.
Time frame: 7 months
Change from baseline to end-line in percent children with at least one fever in the past two weeks.
Time frame: 7 months
Change from baseline to end-line in percent children with at least one respiratory infection in the past two weeks.
Time frame: 7 months
Change from baseline to end-line in percent children with at least one instance of vomiting in the past two weeks.
Contact information is provided by the study sponsor or research team.
Edward Frongillo, PhD
CONTACT
Leila Larson, PhD MPH
CONTACT
University of South Carolina
Other
Impact of Combined Nutrition, Responsive Parenting, and Health Intervention on Childhood Development Study
Acronym: BUNDLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07248397
Early Childhood Development (ECD)
Taoyuan, Taiwan
View Trial DetailsNCT04114305
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
View Trial Details