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Community-based Nutrition Program Effectiveness Evaluation in Afghanistan

Primary Purpose

Child Malnutrition, Breast Feeding, Nutrition

Status
Terminated
Phase
Not Applicable
Locations
Afghanistan
Study Type
Interventional
Intervention
Community Based Nutrition Package (CNBP)
Sponsored by
FHI 360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Child Malnutrition focused on measuring Nutrition, Breastfeeding, Handwashing, Food security, Low and Middle Income Country, Infant and Young Child Feeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Not applicable - Community-Based
  • Not applicable - Community-Based
  • Not applicable - Community-based

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Community-Based Nutrition Package

Standard of care

Arm Description

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.

Current standard of existing community health services.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of women who report initiating breastfeeding within one hour of delivery
Initiating breastfeeding within one hour of birth will be measured by asking the women/mother if she initiated breastfeeding within one hour after the baby was delivered
Proportion of women who report exclusive breastfeeding for the first six months of a baby's life
Exclusive breastfeeding is defined as giving infants only breastmilk, with no supplemental solid foods or liquids, including water. This measure is by self-reported practice from the mother and is constructed from questions about first liquids/feeds, all liquids taken prior to six months of age, and age of first solid food.
Food Insecurity Experience Score
The level of household food insecurity experience, and ordinal categorical measure with values ranging from 0 to 8, as measured using the United Nation's Food and Agriculture Organization's Food Insecurity Experience Survey (FIES).
Participation in household decision-making
The role of men and women in the household in terms of primary decision maker is examined by a set of 8 items adapted from the Demographic and Health Survey. Nominal categorical items record the primary decision-maker within the household for a number of important decisions, including health care seeking behavior, major and minor household purchases, and behaviors related to nutrition such as food acquisition, preparation and consumption.
Proportion of respondents who can name five critical times for washing hands to prevent disease transmission
Handwashing knowledge will be measured by asking respondents if they can name the five critical times for washing hands to prevent disease transmission. Those five times include: after using the toilet, before eating, before preparing food, before breastfeeding and after changing a baby's diaper/napkin (or cleaning the baby if a diaper/napkin isn't used).
Proportion of households with a handwashing facilities stocked with soap
Presence of a handwashing station/facility with soap within the home will be measured both through self-report and through direct observation by the data collector, if permission is given by the participant and/or head of household.

Full Information

First Posted
October 18, 2019
Last Updated
August 10, 2020
Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID), Ministry of Public Health, Islamic Republic of Afghanistan, UNICEF
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1. Study Identification

Unique Protocol Identification Number
NCT04133766
Brief Title
Community-based Nutrition Program Effectiveness Evaluation in Afghanistan
Official Title
Community-based Nutrition Program Effectiveness Evaluation in Afghanistan
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding for the study withdrawn by sponsor after baseline data collected
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID), Ministry of Public Health, Islamic Republic of Afghanistan, UNICEF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Malnutrition, Breast Feeding, Nutrition
Keywords
Nutrition, Breastfeeding, Handwashing, Food security, Low and Middle Income Country, Infant and Young Child Feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4076 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community-Based Nutrition Package
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Current standard of existing community health services.
Intervention Type
Behavioral
Intervention Name(s)
Community Based Nutrition Package (CNBP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of children ages 6-23 months who receive a minimum acceptable diet
Description
Proportion of children ages 6-23 months who receive a World Health Organization-defined minimum acceptable diet
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Proportion of women who report initiating breastfeeding within one hour of delivery
Description
Initiating breastfeeding within one hour of birth will be measured by asking the women/mother if she initiated breastfeeding within one hour after the baby was delivered
Time Frame
18 months
Title
Proportion of women who report exclusive breastfeeding for the first six months of a baby's life
Description
Exclusive breastfeeding is defined as giving infants only breastmilk, with no supplemental solid foods or liquids, including water. This measure is by self-reported practice from the mother and is constructed from questions about first liquids/feeds, all liquids taken prior to six months of age, and age of first solid food.
Time Frame
18 months
Title
Food Insecurity Experience Score
Description
The level of household food insecurity experience, and ordinal categorical measure with values ranging from 0 to 8, as measured using the United Nation's Food and Agriculture Organization's Food Insecurity Experience Survey (FIES).
Time Frame
18 months
Title
Participation in household decision-making
Description
The role of men and women in the household in terms of primary decision maker is examined by a set of 8 items adapted from the Demographic and Health Survey. Nominal categorical items record the primary decision-maker within the household for a number of important decisions, including health care seeking behavior, major and minor household purchases, and behaviors related to nutrition such as food acquisition, preparation and consumption.
Time Frame
18 months
Title
Proportion of respondents who can name five critical times for washing hands to prevent disease transmission
Description
Handwashing knowledge will be measured by asking respondents if they can name the five critical times for washing hands to prevent disease transmission. Those five times include: after using the toilet, before eating, before preparing food, before breastfeeding and after changing a baby's diaper/napkin (or cleaning the baby if a diaper/napkin isn't used).
Time Frame
18 months
Title
Proportion of households with a handwashing facilities stocked with soap
Description
Presence of a handwashing station/facility with soap within the home will be measured both through self-report and through direct observation by the data collector, if permission is given by the participant and/or head of household.
Time Frame
18 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Said Iftekhar Sadaat, MD, MPH
Organizational Affiliation
Ministry of Public Health, Islamic Republic of Afghanistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Not applicable - Community-Based
City
Ghazni
Country
Afghanistan
Facility Name
Not applicable - Community-Based
City
Herat
Country
Afghanistan
Facility Name
Not applicable - Community-based
City
Parwan
Country
Afghanistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 12 months of study completion
IPD Sharing Access Criteria
Data will be made available without restriction.

Learn more about this trial

Community-based Nutrition Program Effectiveness Evaluation in Afghanistan

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