Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): A Community-Based Bundled Nutrition and Parenting Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 960
- 试验地点
- 1
- 主要终点
- Change in early child development
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •None (only those households not meeting all the above criteria will be excluded from the study)
结局指标
主要结局
Change in early child development
时间窗: 12 months
Bayley Scales of Infant and Toddler Development, Third Edition is used to assess cognitive, language, and motor development. Each domain of development is reported separately. In each scale, raw scores are converted to composite scores ranging from 40-160. The average score is 100 and the standard deviation is 15. A higher score denotes higher performance.
Change in child dietary diversity (24 hrs)
时间窗: 12 months
Child dietary diversity (24 hours) defined as the number of food groups out of eight food groups consumed in the previous day based on World Health Organization (WHO) guidelines and is assessed in children aged six months or older. A higher score reflects a higher likelihood of reaching a nutritionally adequate diet.
次要结局
- Child nutrition status(12 months)
- Proportion of children who meet minimum meal frequency guidelines(12 months)
- Caregiver early childhood development (ECD) knowledge(12 months)
- Change from baseline in household food allocation of animal source foods(12 months)
- Child dietary diversity (7 days)(12 months)
- Responsive feeding practices(12 months)
- Caregiver stimulation practices(12 months)
- Co-parenting(12 months)
- Parent-child interactions(12 months)
- Caregiver infant and young child feeding (IYCF) knowledge(12 months)
- Couples' communication (frequency, quality) and decision-making(12 months)
- Change in frequency of caregiver handwashing with cleansing agent at critical times during the past 24 hours(12 months)
- Change in frequency of child handwashing with cleansing agent at critical times during the past 24 hours(12 months)
- Caregiver water, sanitation, and hygiene (WASH) knowledge(12 months)
- Time use patterns(12 months)
- Proportion of households with observed animal feces in house or compound(12 months)
- Intimate partner violence (IPV)(12 months)
- Gender equitable attitudes(12 months)
- Proportion of households that purify drinking water(12 months)
- Parenting stress(12 months)
- Maternal and paternal depressive symptoms(12 months)
研究者
Mary Pat Kieffer
Senior Director for Health
Project Concern International