Clinical trial NCT04133766: Community-based Nutrition Program Effectiveness Evaluation in Afghanistan
Official title: Community-based Nutrition Program Effectiveness Evaluation in Afghanistan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Malnutrition
Breast Feeding
Nutrition
Keywords: Nutrition
Breastfeeding
Handwashing
Food security
Low and Middle Income Country
Infant and Young Child Feeding
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Ministry of Public Health, Islamic Republic of Afghanistan
name: UNICEF
First posted: 2019-10-21
Enrollment: 4076
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will be a mixed methods, two-arm, cluster-randomized controlled trial. The primary aim of this evaluation is to measure the effectiveness of the Community-Based Nutrition Package intervention on child feeding practices among parents/caregivers to children 6 to 23 months of age in Afghanistan.

Detailed description: The study will be a mixed methods, two-arm cluster-randomized controlled trial (CRT). Health facilities eligible to implement the CBNP in their catchment areas will serve as the unit of implementation and be randomly allocated to treatment or control groups. For each health facility, up to four health posts, among the 6-10 health posts typically attached to a health facility, will be randomly selected. Households in communities served by selected health posts will be mapped and a list of households with eligible participants will generated from which a random sample will be selected. Structured questionnaires will be administered to separate samples of women with children 6-23 months of age at baseline then approximately 18 months later. Semi-structured, in-depth interviews will also be conducted with a sub-set of selected women and samples of their husbands and mothers-in-law at baseline and endline.

Eligibility criteria: Inclusion criteria:

* Married adult woman (all married women are considered adults in Afghanistan, regardless of age)
* Has a child between 6 and 23 months of age. For women with more than one living child between ages 6 and 23 months, questions will be asked regarding dietary experiences for the elder of the two. For twins or multiple order siblings, the eldest will be selected based on birth order.
* Resident in the household

Exclusion criteria:

No specific exclusion criteria.

Primary outcomes:
measure: Proportion of children ages 6-23 months who receive a minimum acceptable diet
timeFrame: 18 months
Secondary outcomes:
measure: Proportion of women who report initiating breastfeeding within one hour of delivery
timeFrame: 18 months
measure: Proportion of women who report exclusive breastfeeding for the first six months of a baby's life
timeFrame: 18 months
measure: Food Insecurity Experience Score
timeFrame: 18 months
measure: Participation in household decision-making
timeFrame: 18 months
measure: Proportion of respondents who can name five critical times for washing hands to prevent disease transmission
timeFrame: 18 months
measure: Proportion of households with a handwashing facilities stocked with soap
timeFrame: 18 months
Other outcomes:
Locations:
city: Ghazni
country: Afghanistan
facility: Not applicable - Community-Based
city: Herat
country: Afghanistan
facility: Not applicable - Community-Based
city: Parwan
country: Afghanistan
facility: Not applicable - Community-based
Study officials:
affiliation: Ministry of Public Health, Islamic Republic of Afghanistan
name: Said Iftekhar Sadaat, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: