StuntingNCT04581993
Effectiveness of SNF and SBCC to Prevent Stunting Among Children in Afghanistan: a Quasi-experimental Study
A study testing Super Cereal - wheat soya blend with sugar, Lipid-based nutrient supplement-medium quantity (LNS-MQ) and Social and behavior change communication (SBCC) in people with Stunting and Malnutrition, Child, run by Aga Khan University at 1 site in Afghanistan.
Trial summary
Over the years, there has been some progress made in reducing stunting in Afghanistan, the prevalence remains high with half of the provinces experiencing rates above the WHO alert threshold. Read more about this study
- Who is it for?
- Ages 6 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Stunting, Malnutrition, Child
- What is being tested?
- Super Cereal - wheat soya blend with sugar, Lipid-based nutrient supplement-medium quantity (LNS-MQ) and Social and behavior change communication (SBCC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,100 participants
- Where
- 1 siteAfghanistan
- Study dates
- 1 Feb 2021to 31 Dec 2022
- 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 6 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant and lactating women
- Children 6-23 months
- Willing to participate
Who cannot join
- Non pregnant and lactating women
- Children >24 months
- Refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Specialized Nutritious Foods, Social and Behavior Change Communication Interventions to Prevent Stunting Among Children in Badakhshan Province, Afghanistan: a Quasi-experimental Study
Over the years, there has been some progress made in reducing stunting in Afghanistan, the prevalence remains high with half of the provinces experiencing rates above the WHO alert threshold. As part of the Country Strategic Plan (CSP), the World Food Programme (WFP) plans to implement a stunting prevention programme in collaboration with Ministry of Public Health (MoPH) through its Public Nutrition Department (PND) in selected locations with stunting rates above 45%. The programme will emphasis on appropriate nutrition support in the '1000 days' window of opportunity with special focus on proven effective nutrition interventions such appropriate breast feeding, complementary feeding, micronutrient supplementation, malnutrition treatment and prevention, WASH.
Read the detailed description
Over the years, there has been some progress made in reducing stunting in Afghanistan, the prevalence remains high with half of the provinces experiencing rates above the WHO alert threshold. As part of the Country Strategic Plan (CSP), the World Food Programme (WFP) plans to implement a stunting prevention programme in collaboration with Ministry of Public Health (MoPH) through its Public Nutrition Department (PND) in selected locations with stunting rates above 45%. The programme will emphasis on appropriate nutrition support in the '1000 days' window of opportunity with special focus on proven effective nutrition interventions such appropriate breast feeding, complementary feeding, micronutrient supplementation, malnutrition treatment and prevention, WASH. This will therefore take the form of an integrated approach ensuring the targeted beneficiaries are supported to access nutrition assistance as well as other complimentary interventions provided in-kind by study partners or promoted through social and behaviour change communication (SBCC). WFP will target pregnant and lactating women (PLW) and children aged 6-23 months but will also engage men and players that influence maternal infant and young child nutrition practices. Through this programme, children aged 6-23 months will receive lipid-based nutrient supplement - medium quantity (LNS-MQ) to complement their diets while PLW will receive Super Cereal - wheat soya blend with sugar.
An operational research study was embedded in the stunting prevention programme by credible third-party to determine the extent to which the new actions will influence nutrition outcomes and practices. Introducing the provision of SNF, SBCC as well as formulation and adoption of local culturally acceptable recipes for complementary feeding from locally available nutritious food would be new additions to the current Community Based Nutrition Program (CBNP) package in the implementation phase. During the project implementation, emphasis will be placed will be placed on the adoption of the locally formulated complementary foods as well as application of knowledge and practices promoted through the SBCC activities as part of the exit strategy and ensuring a lasting impact of the project.
Therefore, the Centre of Excellence in Women and Child Health, Aga Khan University, Pakistan proposes an operational research study with mix-methods including formative research, quasi-experimental design to evaluate the stunting prevention programme and process evaluations for stronger evidence base on the effectiveness of proposed interventions on prevention of stunting and developing viable programmes on nutrition under "real" operational conditions.
- Conditions
- Stunting, Malnutrition, Child
- Being tested
- Super Cereal - wheat soya blend with sugar, Lipid-based nutrient supplement-medium quantity (LNS-MQ), Social and behavior change communication (SBCC)
- Keywords
- Stunting, Children, Specialized Nutritious Foods, Social and Behavior Change Communication, Afghanistan
- Medical subject headings
- Growth Disorders, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Cereal - wheat soya blend with sugarDietary supplement
Pregnant and lactating women will received Super Cereal during pregnancy and first six months of lactation.
Lipid-based nutrient supplement-medium quantity (LNS-MQ)Dietary supplement
Children will receive LNS during 6-23 months of age.
Social and behavior change communication (SBCC)Behavioural
SBCC will be provided to improve care-givers knowledge, attitudes and practices related to infant and young child feeding.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Pregnant and lactating women (PLW) will receive Super Cereal - wheat soya blend with sugar and children aged 6-23 months will receive lipid-based nutrient supplement-medium quantity (LNS-MQ). Social and behavior change communication (SBCC), community mobilization, referrals, identification of model families, food demonstrations, local recipe) ration/beneficiary entitlement cards will be provided for easy verification and tracking during delivery of intervention. Receives: Dietary Supplement: Super Cereal - wheat soya blend with sugar; Dietary Supplement: Lipid-based nutrient supplement-medium quantity (LNS-MQ); Behavioral: Social and behavior change communication (SBCC) |
| Control | No intervention | Control districts will receive routine health care services available in the study area. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in stunting
10% reduction in stunting among children 6-23 months in the intervention compare to control
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 posted9 Oct 2020
- Study start1 Feb 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of public Health Afghanistan, United Nations World Food Programme (WFP), The Aga Khan Foundation, Aga Khan Health Services
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Sajid B Soofi, MBBS, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581993
- Sponsor's protocol ID
- Stunting Study Afghanistan
- Status last verified
- Aug 2023
- First submitted
- 8 Oct 2020
- Last updated
- 16 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soofi SB, Khan GN, Sajid M, Hussainyar MA, Shams S, Shaikh M, Ouma C, Azami S, Naeemi M, Hussain A, Umer M, Hussain I, Ahmed I, Ariff S. Specialized nutritious foods and behavior change communication interventions during the first 1000 d of life to prevent stunting: a quasi-experimental study in Afghanistan. Am J Clin Nutr. 2024 Sep;120(3):560-569. doi: 10.1016/j.ajcnut.2024.07.007. Epub 2024 Jul 14.
PubMed 39004283
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Specialized Nutritious Foods, Social and Behavior Change Communication Interventions to Prevent Stunting Among Children in Badakhshan Province, Afghanistan: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04581993
- Acronym / sponsor ID
- Stunting Study Afghanistan
- Conditions
- Stunting, Malnutrition, Child
- Keywords
- Stunting, Children, Specialized Nutritious Foods, Social and Behavior Change Communication, Afghanistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33,100 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Ministry of public Health Afghanistan, United Nations World Food Programme (WFP), The Aga Khan Foundation, Aga Khan Health Services
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Oct 2020 (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.
Over the years, there has been some progress made in reducing stunting in Afghanistan, the prevalence remains high with half of the provinces experiencing rates above the WHO alert threshold. As part of the Country Strategic Plan (CSP), the World Food Programme (WFP) plans to implement a stunting prevention programme in collaboration with Ministry of Public Health (MoPH) through its Public Nutrition Department (PND) in selected locations with stunting rates above 45%. The programme will emphasis on appropriate nutrition support in the '1000 days' window of opportunity with special focus on proven effective nutrition interventions such appropriate breast feeding, complementary feeding, micronutrient supplementation, malnutrition treatment and prevention, WASH.
Detailed description
Over the years, there has been some progress made in reducing stunting in Afghanistan, the prevalence remains high with half of the provinces experiencing rates above the WHO alert threshold. As part of the Country Strategic Plan (CSP), the World Food Programme (WFP) plans to implement a stunting prevention programme in collaboration with Ministry of Public Health (MoPH) through its Public Nutrition Department (PND) in selected locations with stunting rates above 45%. The programme will emphasis on appropriate nutrition support in the '1000 days' window of opportunity with special focus on proven effective nutrition interventions such appropriate breast feeding, complementary feeding, micronutrient supplementation, malnutrition treatment and prevention, WASH. This will therefore take the form of an integrated approach ensuring the targeted beneficiaries are supported to access nutrition assistance as well as other complimentary interventions provided in-kind by study partners or promoted through social and behaviour change communication (SBCC). WFP will target pregnant and lactating women (PLW) and children aged 6-23 months but will also engage men and players that influence maternal infant and young child nutrition practices. Through this programme, children aged 6-23 months will receive lipid-based nutrient supplement - medium quantity (LNS-MQ) to complement their diets while PLW will receive Super Cereal - wheat soya blend with sugar.
An operational research study was embedded in the stunting prevention programme by credible third-party to determine the extent to which the new actions will influence nutrition outcomes and practices. Introducing the provision of SNF, SBCC as well as formulation and adoption of local culturally acceptable recipes for complementary feeding from locally available nutritious food would be new additions to the current Community Based Nutrition Program (CBNP) package in the implementation phase. During the project implementation, emphasis will be placed will be placed on the adoption of the locally formulated complementary foods as well as application of knowledge and practices promoted through the SBCC activities as part of the exit strategy and ensuring a lasting impact of the project.
Therefore, the Centre of Excellence in Women and Child Health, Aga Khan University, Pakistan proposes an operational research study with mix-methods including formative research, quasi-experimental design to evaluate the stunting prevention programme and process evaluations for stronger evidence base on the effectiveness of proposed interventions on prevention of stunting and developing viable programmes on nutrition under "real" operational conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Super Cereal - wheat soya blend with sugar, Dietary Supplement: Lipid-based nutrient supplement-medium quantity (LNS-MQ), Behavioral: Social and behavior change communication (SBCC)Pregnant and lactating women (PLW) will receive Super Cereal - wheat soya blend with sugar and children aged 6-23 months will receive lipid-based nutrient supplement-medium quantity (LNS-MQ). Social and behavior change communication (SBCC), community mobilization, referrals, identification of model families, food demonstrations, local recipe) ration/beneficiary entitlement cards will be provided for easy verification and tracking during delivery of intervention. |
| Control | No intervention | –Control districts will receive routine health care services available in the study area. |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant and lactating women
- Children 6-23 months
- Willing to participate
Key exclusion criteria (3 listed)
- Non pregnant and lactating women
- Children >24 months
- Refuse to participate
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 |
|---|---|---|
| Super Cereal - wheat soya blend with sugarPregnant and lactating women will received Super Cereal during pregnancy and first six months of lactation. | Dietary supplement | Intervention |
| Lipid-based nutrient supplement-medium quantity (LNS-MQ)Children will receive LNS during 6-23 months of age. | Dietary supplement | Intervention |
| Social and behavior change communication (SBCC)SBCC will be provided to improve care-givers knowledge, attitudes and practices related to infant and young child feeding. | Behavioural | Intervention |
Primary outcome
Reduction in stunting
Time frame: 18 months
10% reduction in stunting among children 6-23 months in the intervention compare to control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 39004283Soofi SB, Khan GN, Sajid M, Hussainyar MA, Shams S, Shaikh M, Ouma C, Azami S, Naeemi M, Hussain A, Umer M, Hussain I, Ahmed I, Ariff S. Specialized nutritious foods and behavior change communication interventions during the first 1000 d of life to prevent stunting: a quasi-experimental study in Afghanistan. Am J Clin Nutr. 2024 Sep;120(3):560-569. doi: 10.1016/j.ajcnut.2024.07.007. Epub 2024 Jul 14.
- Individual participant dataSharing planned: No
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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.
Sajid B Soofi, MBBS, FCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Cereal - wheat soya blend with sugar, Lipid-based nutrient supplement-medium quantity (LNS-MQ) and Social and behavior change communication (SBCC) in people with Stunting and Malnutrition, Child, run by Aga Khan University at 1 site 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 3 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: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in stunting (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581993, which also lists 1 linked publication.
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 16 Aug 2023.