StuntingNCT03689218
Evidence Generation Related to Stunting Prevention in Balochistan
A study testing Maamta (Nutritious Food Supplement) and Wawamum (Lipid-Based Nutrient Supplement) in people with Stunting and Low Birth Weight, run by Aga Khan University at 2 sites in Pakistan.
Trial summary
The World Food Programme (WFP) has signed MoU with Planning and Development Department of Balochistan in collaboration with Nutrition Cell and National Programme for Family Planning and Primary Health Care, Balochistan for the prevention of stunting. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting, Low Birth Weight, Anemia in Pregnancy
- What is being tested?
- Maamta (Nutritious Food Supplement) and Wawamum (Lipid-Based Nutrient Supplement)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,180 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Aug 2018to 30 Nov 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 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pregnant women during 1-3 months of pregnancy
- Child age between 6-12 month at the time of enrollment
- Willing to participate in the study and provide informed consent
- Living in catchment area of LHW
Who cannot join
- More than 4 months of pregnancy
- More than 12 months of child age
- Not willing to participate in the study and unable provide informed consent
- Not living in catchment area of LHW
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Aga Khan University
Karachi, Sindh, 74800
District Pishin & Quetta
Quetta, Balochistan, 87300
About this study
Official title: Evidence Generation Related to Stunting Prevention Through Multisectoral Approaches Coupled With Appropriate Complementary Feeding Practices in Pishin, Balochistan
The World Food Programme (WFP) has signed MoU with Planning and Development Department of Balochistan in collaboration with Nutrition Cell and National Programme for Family Planning and Primary Health Care, Balochistan for the prevention of stunting. The project will utilize the window of opportunity (1000 days from conception to 2 years) for addressing stunting in children under-two years. Therefore project will recruit pregnant women during first trimester and newborns who delivered from recruited pregnant women will be followed until the age of 2 years. Children 6-12 months of age will be enrolled and followed until the age of two years. The interventions included nutritional supplements during pregnancy, lactation and for children during 6-24 months of age. The project will be implemented in Lady Health Workers (LHWs) covered areas of districts Pishin and Quetta, Balochistan.
Read the detailed description
The World Food Programme (WFP) has signed MoU with Planning and Development Department of Balochistan in collaboration with Nutrition Cell and National Programme for Family Planning and Primary Health Care, Balochistan for the prevention of stunting. The Stunting Prevention interventions will contribute to revert the trends of chronic malnutrition among children less than 5 years of age. The intervention is coupled with plans to document the impact through credible evidence generation in collaboration with academic institute/s through a research based study in Pishin and Quetta Districts.
Balochistan is the most underdeveloped areas of Pakistan with a very poor health and nutrition situation. According to the National Nutrition Survey (NNS) 2011, the prevalence of stunting in Balochistan is 52% amongst the highest rates in the country. The prevalence of wasting in Balochistan is 16%, indicating a public health emergency. Women and children also suffer from some of the world's highest levels of vitamin and mineral deficiencies with maternal anaemia at 47% in Balochistan and Vitamin A deficiency in children at 74% in Balochistan.
Although a number of nutrition approaches and actions have been implemented in Pakistan at various times, there hasn't been a comprehensive approach to prevent under nutrition in general, and stunting specifically. WFP \& MOH will be implementing the nutrition interventions, and this proposal is widely implemented/evaluated in Pakistan, so the project aims to contribute towards to fill the evidence gap for the prevention of stunting through multisectoral approaches coupled with appropriate complementary practices in Balochistan. The evidence base for undernutrition and stunting prevention globally is actually quite well established. There is existent evidence that points to the need to intervene during gestation and the first two years of life (1000 days) to prevent child undernutrition and its consequences. It suggests that investments in interventions during this window of opportunity are likely to have the greatest benefits.
The effectiveness of the project will be measured in terms of the impact of the proposed interventions on the stunting and nutritional outcomes in the target group (children and PLW). Given the conditions of project implementation, a mixed-methods study design including formative research, cross-sectional baseline \& endline surveys, cluster randomized controlled trial (RCT) and process evaluation would be appropriate to assess the impact of the intervention. The control clusters will receive routine public and private health services available in the area. The RCT will utilize the window of opportunity (1000 days from conception to 2 years) for addressing stunting in children under-two years. A cohort of children between the age of 6-12 month will also be enrolled in the study and will be followed up to the age of 24 months.
- Conditions
- Stunting, Low Birth Weight, Anemia in Pregnancy
- Being tested
- Maamta (Nutritious Food Supplement), Wawamum (Lipid-Based Nutrient Supplement)
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maamta (Nutritious Food Supplement)Dietary supplement
Pregnant women will receive 30 sachets of Maamta during pregnancy and first six months of lactation.
Wawamum (Lipid-Based Nutrient Supplement)Dietary supplement
Children 6-24 months will receive 30 sachets of Wawamum every month during the study.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control arm will receive routine public and private health services available in the area. |
| Intervention | Experimental | Pregnant women in intervention arm will receive 30 sachets of Maamta (Nutritious Food Supplement) during pregnancy and first six months of lactation. Children 6-24 months of age will receive 30 sachets of Wawamum (Lipid-Based Nutrient Supplement) every month during the study. Receives: Dietary Supplement: Maamta (Nutritious Food Supplement); Dietary Supplement: Wawamum (Lipid-Based Nutrient Supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in stunting in children at 24 months of age
10% reduction in stunting
Measured: 32 months
Secondary outcomes (3)
Improvement in anemia during pregnancy
Improvement in anemia during pregnancy
Measured: 9 months
Improvement in anemia in children
Improvement in anemia in children
Measured: 18 months
Reduction in low birth weight
Reduction in low birth weight in newborns
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start15 Aug 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Trust for Vaccines & Immunization (TVI), Department of Health, Government of Balochistan, World Food Program (WFP), Nutrition Cell, Government of Balochistan, Youth Organization, Balochistan
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Sajid B Soofi, FCPS, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689218
- Sponsor's protocol ID
- Stunting Study Balochistan
- Status last verified
- Jul 2021
- First submitted
- 27 Sep 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Generation Related to Stunting Prevention Through Multisectoral Approaches Coupled With Appropriate Complementary Feeding Practices in Pishin, Balochistan
- ClinicalTrials.gov ID
- NCT03689218
- Acronym / sponsor ID
- Stunting Study Balochistan
- Conditions
- Stunting, Low Birth Weight, Anemia in Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,180 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Trust for Vaccines & Immunization (TVI), Department of Health, Government of Balochistan, World Food Program (WFP), Nutrition Cell, Government of Balochistan, Youth Organization, Balochistan
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 28 Sep 2018 (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 World Food Programme (WFP) has signed MoU with Planning and Development Department of Balochistan in collaboration with Nutrition Cell and National Programme for Family Planning and Primary Health Care, Balochistan for the prevention of stunting. The project will utilize the window of opportunity (1000 days from conception to 2 years) for addressing stunting in children under-two years. Therefore project will recruit pregnant women during first trimester and newborns who delivered from recruited pregnant women will be followed until the age of 2 years. Children 6-12 months of age will be enrolled and followed until the age of two years. The interventions included nutritional supplements during pregnancy, lactation and for children during 6-24 months of age. The project will be implemented in Lady Health Workers (LHWs) covered areas of districts Pishin and Quetta, Balochistan.
Detailed description
The World Food Programme (WFP) has signed MoU with Planning and Development Department of Balochistan in collaboration with Nutrition Cell and National Programme for Family Planning and Primary Health Care, Balochistan for the prevention of stunting. The Stunting Prevention interventions will contribute to revert the trends of chronic malnutrition among children less than 5 years of age. The intervention is coupled with plans to document the impact through credible evidence generation in collaboration with academic institute/s through a research based study in Pishin and Quetta Districts.
Balochistan is the most underdeveloped areas of Pakistan with a very poor health and nutrition situation. According to the National Nutrition Survey (NNS) 2011, the prevalence of stunting in Balochistan is 52% amongst the highest rates in the country. The prevalence of wasting in Balochistan is 16%, indicating a public health emergency. Women and children also suffer from some of the world's highest levels of vitamin and mineral deficiencies with maternal anaemia at 47% in Balochistan and Vitamin A deficiency in children at 74% in Balochistan.
Although a number of nutrition approaches and actions have been implemented in Pakistan at various times, there hasn't been a comprehensive approach to prevent under nutrition in general, and stunting specifically. WFP \& MOH will be implementing the nutrition interventions, and this proposal is widely implemented/evaluated in Pakistan, so the project aims to contribute towards to fill the evidence gap for the prevention of stunting through multisectoral approaches coupled with appropriate complementary practices in Balochistan. The evidence base for undernutrition and stunting prevention globally is actually quite well established. There is existent evidence that points to the need to intervene during gestation and the first two years of life (1000 days) to prevent child undernutrition and its consequences. It suggests that investments in interventions during this window of opportunity are likely to have the greatest benefits.
The effectiveness of the project will be measured in terms of the impact of the proposed interventions on the stunting and nutritional outcomes in the target group (children and PLW). Given the conditions of project implementation, a mixed-methods study design including formative research, cross-sectional baseline \& endline surveys, cluster randomized controlled trial (RCT) and process evaluation would be appropriate to assess the impact of the intervention. The control clusters will receive routine public and private health services available in the area. The RCT will utilize the window of opportunity (1000 days from conception to 2 years) for addressing stunting in children under-two years. A cohort of children between the age of 6-12 month will also be enrolled in the study and will be followed up to the age of 24 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control arm will receive routine public and private health services available in the area. |
| Intervention | Experimental | Dietary Supplement: Maamta (Nutritious Food Supplement), Dietary Supplement: Wawamum (Lipid-Based Nutrient Supplement)Pregnant women in intervention arm will receive 30 sachets of Maamta (Nutritious Food Supplement) during pregnancy and first six months of lactation. Children 6-24 months of age will receive 30 sachets of Wawamum (Lipid-Based Nutrient Supplement) every month during the study. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pregnant women during 1-3 months of pregnancy
- Child age between 6-12 month at the time of enrollment
- Willing to participate in the study and provide informed consent
- Living in catchment area of LHW
Key exclusion criteria (4 listed)
- More than 4 months of pregnancy
- More than 12 months of child age
- Not willing to participate in the study and unable provide informed consent
- Not living in catchment area of LHW
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 |
|---|---|---|
| Maamta (Nutritious Food Supplement)Pregnant women will receive 30 sachets of Maamta during pregnancy and first six months of lactation. | Dietary supplement | Intervention |
| Wawamum (Lipid-Based Nutrient Supplement)Children 6-24 months will receive 30 sachets of Wawamum every month during the study. | Dietary supplement | Intervention |
Primary outcome
Reduction in stunting in children at 24 months of age
Time frame: 32 months
10% reduction in stunting
3 secondary outcomes
Improvement in anemia during pregnancy
Time frame: 9 months
Improvement in anemia in children
Time frame: 18 months
Reduction in low birth weight
Time frame: 9 months
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 23 Jul 2021.
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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, FCPS, MBBS principal investigator
Aga Khan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maamta (Nutritious Food Supplement) and Wawamum (Lipid-Based Nutrient Supplement) in people with Stunting and Low Birth Weight, run by Aga Khan University at 2 sites in Pakistan.
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 4 inclusion and 4 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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 in children at 24 months of age (time frame: 32 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 23 Jul 2021.