Child MalnutritionNCT04133766
Community-based Nutrition Program Effectiveness Evaluation in Afghanistan
A study testing Community Based Nutrition Package (CNBP) in people with Child Malnutrition and Breast Feeding, run by FHI 360 at 3 sites in Afghanistan.
Trial 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 more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Malnutrition, Breast Feeding, Nutrition
- What is being tested?
- Community Based Nutrition Package (CNBP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,076 participants
- Where
- 3 sitesAfghanistan
- Study dates
- 1 Nov 2019to 20 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No specific exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
Afghanistan3 sites
Not applicable - Community-Based
Ghazni
Not applicable - Community-Based
Herat
Not applicable - Community-based
Parwan
About this study
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.
- Conditions
- Child Malnutrition, Breast Feeding, Nutrition
- Being tested
- Community Based Nutrition Package (CNBP)
- Keywords
- Nutrition, Breastfeeding, Handwashing, Food security, Low and Middle Income Country, Infant and Young Child Feeding
- Medical subject headings
- Child Nutrition Disorders, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Based Nutrition Package (CNBP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Community Based Nutrition Package (CNBP) |
| Standard of care | No intervention | Current standard of existing community health services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (6)
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
Measured: 18 months
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.
Measured: 18 months
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).
Measured: 18 months
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.
Measured: 18 months
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).
Measured: 18 months
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start1 Nov 2019
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Why it stopped: Funding for the study withdrawn by sponsor after baseline data collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,076 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Public Health, Islamic Republic of Afghanistan, UNICEF
- Responsible party
- Sponsor
- Investigators
- Said Iftekhar Sadaat, MD, MPH, Principal investigator, Ministry of Public Health, Islamic Republic of Afghanistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133766
- Sponsor's protocol ID
- 1407870
- Status last verified
- Aug 2020
- First submitted
- 18 Oct 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Nutrition Program Effectiveness Evaluation in Afghanistan
- ClinicalTrials.gov ID
- NCT04133766
- Acronym / sponsor ID
- 1407870
- Conditions
- Child Malnutrition, Breast Feeding, Nutrition
- Keywords
- Nutrition, Breastfeeding, Handwashing, Food security, Low and Middle Income Country, Infant and Young Child Feeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for the study withdrawn by sponsor after baseline data collected
- Enrolment
- 4,076 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Ministry of Public Health, Islamic Republic of Afghanistan, UNICEF
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-Based Nutrition Package | Experimental | Behavioral: Community 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. |
| Standard of care | No intervention | –Current standard of existing community health services. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- No specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community 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. | Behavioural | Community-Based Nutrition Package |
Primary outcome
Proportion of children ages 6-23 months who receive a minimum acceptable diet
Time frame: 18 months
Proportion of children ages 6-23 months who receive a World Health Organization-defined minimum acceptable diet
6 secondary outcomes
Proportion of women who report initiating breastfeeding within one hour of delivery
Time frame: 18 months
Proportion of women who report exclusive breastfeeding for the first six months of a baby's life
Time frame: 18 months
Food Insecurity Experience Score
Time frame: 18 months
Participation in household decision-making
Time frame: 18 months
Proportion of respondents who can name five critical times for washing hands to prevent disease transmission
Time frame: 18 months
Proportion of households with a handwashing facilities stocked with soap
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Funding for the study withdrawn by sponsor after baseline data collected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Said Iftekhar Sadaat, MD, MPH principal investigator
Ministry of Public Health, Islamic Republic of Afghanistan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Based Nutrition Package (CNBP) in people with Child Malnutrition and Breast Feeding, run by FHI 360 at 3 sites in Afghanistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Afghanistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding for the study withdrawn by sponsor after baseline data collected). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children ages 6-23 months who receive a minimum acceptable diet (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.