Clinical trial NCT03759821: Engaging Fathers for Effective Child Nutrition and Development in Tanzania
Official title: Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): A Community-Based Bundled Nutrition and Parenting Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition and Early Child Development
Keywords: Infant and young child feeding
Nutrition
Stimulation
Parenting
Early childhood development
Social and behavior change
Father involvement
Male engagement
Household decision-making
Community health workers
Peer groups
Integrated interventions
Lead sponsor: Project Concern International
Sponsor class: OTHER
Collaborators: name: Purdue University
name: Harvard School of Public Health (HSPH)
name: Africa Academy for Public Health
name: The Eleanor Crook Foundation
name: Conrad N. Hilton Foundation
name: National Institute for Medical Research, Tanzania
First posted: 2018-11-30
Enrollment: 960
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Eighty villages in the Mara region of Tanzania will be randomly selected and randomly allocated with equal probability and in equal numbers to one of the five EFFECTS study arms. In each participating village, one sub village will be randomly selected with equal probability, and a sampling frame of all households in that sub village will be created with the help of local leaders. Households will be selected from this sampling frame using simple random sampling. The selected households will be listed in random order and visited by study staff, who will assess whether a household meets all inclusion criteria and provides informed consent. Households will be visited until 12 households are enrolled in each village. If not enough eligible households are found, additional households will be selected using the same procedure from the nearest sub village in the same village.
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the independent and combined effectiveness of engaging both mothers and fathers in bundled parenting and nutrition behavior change packages on early child nutrition and development.

Detailed description: The overall aim of EFFECTS is to develop, implement, and evaluate nutrition and parenting interventions that will be delivered by community health workers in the Mara region of Tanzania. We will use a 2x2 factorial cluster randomized controlled study design, plus a local standard of care control group, to evaluate the effectiveness of EFFECTS on the primary outcomes of early child nutrition and development. In total, there will be five study arms: nutrition intervention with mothers, nutrition intervention with mothers and fathers, bundled nutrition and parenting intervention with mothers, bundled nutrition and parenting intervention with mothers and fathers, and a local standard of care control. We hypothesize that an intervention approach that engages fathers will benefit the primary outcomes; a bundled nutrition and parenting package will benefit the same primary outcomes; and that the combined intervention approach - that both engages fathers and bundles nutrition and parenting messages - will have additive benefits on the primary outcomes.

Eligibility criteria: Inclusion Criteria:

* Household has a child aged 0-18 months at study enrollment
* Child has a mother/female caregiver with a male partner
* Mother, father, and child anticipate remaining in the study area for the duration of the study
* The mother, and father where appropriate, is willing to participate in a peer group for the duration of the intervention, receiving full knowledge of the amount of time they are expected to contribute to this study.
* Both mother and father provide informed consent.
* Fathers have to be present in household with mother/child 10 months out of the year

Exclusion Criteria:

* None (only those households not meeting all the above criteria will be excluded from the study)

Primary outcomes:
measure: Change in child dietary diversity (24 hrs)
timeFrame: 12 months
measure: Change in early child development
timeFrame: 12 months
Secondary outcomes:
measure: Child dietary diversity (7 days)
timeFrame: 12 months
measure: Child nutrition status
timeFrame: 12 months
measure: Proportion of children who meet minimum meal frequency guidelines
timeFrame: 12 months
measure: Parent-child interactions
timeFrame: 12 months
measure: Caregiver early childhood development (ECD) knowledge
timeFrame: 12 months
measure: Caregiver infant and young child feeding (IYCF) knowledge
timeFrame: 12 months
measure: Change from baseline in household food allocation of animal source foods
timeFrame: 12 months
measure: Responsive feeding practices
timeFrame: 12 months
measure: Caregiver stimulation practices
timeFrame: 12 months
measure: Co-parenting
timeFrame: 12 months
measure: Couples' communication (frequency, quality) and decision-making
timeFrame: 12 months
measure: Gender equitable attitudes
timeFrame: 12 months
measure: Time use patterns
timeFrame: 12 months
measure: Proportion of households that purify drinking water
timeFrame: 12 months
measure: Proportion of households with observed animal feces in house or compound
timeFrame: 12 months
measure: Change in frequency of caregiver handwashing with cleansing agent at critical times during the past 24 hours
timeFrame: 12 months
measure: Change in frequency of child handwashing with cleansing agent at critical times during the past 24 hours
timeFrame: 12 months
measure: Caregiver water, sanitation, and hygiene (WASH) knowledge
timeFrame: 12 months
measure: Maternal and paternal depressive symptoms
timeFrame: 12 months
measure: Intimate partner violence (IPV)
timeFrame: 12 months
measure: Parenting stress
timeFrame: 12 months
Other outcomes:
Locations:
city: Musoma
country: Tanzania
facility: Project Concern International
state: Mara
Study officials:
affiliation: Project Concern International
name: Mary Pat Kieffer, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Purdue University
name: Nilupa Gunaratna, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard H.T. Chan School of Public Health
name: Aisha Yousafzai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ambikapathi R, Irema I, Lyatuu I, Caswell B, Mosha D, Nyamsangia S, Galvin L, Mangara A, Boncyk M, Froese SL, Verissimo CK, Itatiro J, Kariathi V, Kazonda P, Wandella M, Fawzi W, Killewo J, Mwanyika-Sando M, PrayGod G, Leyna G, Patil C, Gunaratna NS. Gender and Age Differences in Meal Structures, Food Away from Home, Chrono-Nutrition, and Nutrition Intakes among Adults and Children in Tanzania Using a Newly Developed Tablet-Based 24-Hour Recall Tool. Curr Dev Nutr. 2022 Feb 8;6(3):nzac015. doi: 10.1093/cdn/nzac015. eCollection 2022 Mar.