NCT04133766

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,076

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

9 months

First QC Date

October 18, 2019

Last Update Submit

August 10, 2020

Conditions

Keywords

NutritionBreastfeedingHandwashingFood securityLow and Middle Income CountryInfant and Young Child Feeding

Outcome Measures

Primary Outcomes (1)

  • Proportion of children ages 6-23 months who receive a minimum acceptable diet

    Proportion of children ages 6-23 months who receive a World Health Organization-defined minimum acceptable diet

    18 months

Secondary Outcomes (6)

  • Proportion of women who report initiating breastfeeding within one hour of delivery

    18 months

  • Proportion of women who report exclusive breastfeeding for the first six months of a baby's life

    18 months

  • Food Insecurity Experience Score

    18 months

  • Participation in household decision-making

    18 months

  • Proportion of respondents who can name five critical times for washing hands to prevent disease transmission

    18 months

  • +1 more secondary outcomes

Study Arms (2)

Community-Based Nutrition Package

EXPERIMENTAL

The Community-Based Nutrition Package (CBNP) is a multi-level intervention that comprises: advocacy and training for government stakeholders and employees; selection and training of master trainers who then cascade the training at provincial level; and selection and training of community-level Nutrition Mobilizing Teams. The Nutrition Mobilizing Teams then organize a 2-day community mobilization session in the catchment areas of each health post to develop a community nutrition plan, which is then implemented by community health workers and two additional volunteers under the mentorship of the Nutrition Mobilizing Teams and with the support of the community members that participated in the community mobilization session.

Behavioral: Community Based Nutrition Package (CNBP)

Standard of care

NO INTERVENTION

Current standard of existing community health services.

Interventions

The Community-Based Nutrition Package (CBNP) is a multi-level intervention that comprises: advocacy and training for government stakeholders and employees; selection and training of master trainers who then cascade the training at provincial level; and selection and training of community-level Nutrition Mobilizing Teams. The Nutrition Mobilizing Teams then organize a 2-day community mobilization session in the catchment areas of each health post to develop a community nutrition plan, which is then implemented by community health workers and two additional volunteers under the mentorship of the Nutrition Mobilizing Teams and with the support of the community members that participated in the community mobilization session.

Community-Based Nutrition Package

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Not applicable - Community-Based

Ghazni, Afghanistan

Location

Not applicable - Community-Based

Herat, Afghanistan

Location

Not applicable - Community-based

Parwan, Afghanistan

Location

MeSH Terms

Conditions

Child Nutrition DisordersBreast Feeding

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Study Officials

  • Said Iftekhar Sadaat, MD, MPH

    Ministry of Public Health, Islamic Republic of Afghanistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 21, 2019

Study Start

November 1, 2019

Primary Completion

July 20, 2020

Study Completion

July 20, 2020

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available within 12 months of study completion
Access Criteria
Data will be made available without restriction.

Locations