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TerminatedNCT04133766Updated Aug 12, 2020

Community-based Nutrition Program Effectiveness Evaluation in Afghanistan

An interventional study of Community Based Nutrition Package (CNBP) in Child Malnutrition, Breast Feeding and Nutrition, sponsored by FHI 360. Terminated at 3 sites in Afghanistan. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-12.

Sponsored by FHI 360 · Not applicable, Interventional, and Prevention

Why this study was terminated
Funding for the study withdrawn by sponsor after baseline data collected
Phase
Not applicable
Study type
Interventional
Enrollment
4,076
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Child Malnutrition
  • Breast Feeding
  • Nutrition

Keywords

  • Nutrition
  • Breastfeeding
  • Handwashing
  • Food security
  • Low and Middle Income Country
  • Infant and Young Child Feeding
03

In context

Child Nutrition Disorders

167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.

This study's enrollment of 4,076 is above the median of 402 across 132 interventional studies indexed under Child Nutrition Disorders.

Browse Child Nutrition Disorders studies →

Lead sponsor

FHI 360 is the lead sponsor of 59 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

No specific exclusion criteria.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,076 participants (actual)

Study arms

  • Experimental
    Community-Based Nutrition Package

    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)

  • No intervention
    Standard of care

    Current standard of existing community health services.

Interventions

  • BehavioralCommunity Based Nutrition Package (CNBP)

    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.

06

What researchers measure

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

    Time frame: 18 months

Secondary outcomes

  1. 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

    Time frame: 18 months

  2. 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.

    Time frame: 18 months

  3. 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).

    Time frame: 18 months

  4. 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.

    Time frame: 18 months

  5. 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).

    Time frame: 18 months

  6. 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.

    Time frame: 18 months

07

Study locations

3 sites
  • Not applicable - Community-Based
    Ghazni, Afghanistan
  • Not applicable - Community-Based
    Herat, Afghanistan
  • Not applicable - Community-based
    Parwan, Afghanistan
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data will be available within 12 months of study completion

Access criteria: Data will be made available without restriction.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in Jul 2020, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2019
First posted
Oct 21, 2019
StartActual
Nov 1, 2019
Primary completionActual
Jul 20, 2020
CompletionActual
Jul 20, 2020
Last update
Aug 12, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04133766
Lead sponsor
FHI 360
Collaborators
United States Agency for International Development (USAID), Ministry of Public Health, Islamic Republic of Afghanistan, UNICEF
Responsible party
Sponsor
First posted
Oct 21, 2019
Start date
Nov 1, 2019
Primary completion
Jul 20, 2020
Completion
Jul 20, 2020
Last update
Aug 12, 2020

Study contacts

Said Iftekhar Sadaat, MD, MPH
principal investigator · Ministry of Public Health, Islamic Republic of Afghanistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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