Evidence Generation Related to Stunting Prevention in Balochistan
Primary Purpose
Stunting, Low Birth Weight, Anemia in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Maamta (Nutritious Food Supplement)
Wawamum (Lipid-Based Nutrient Supplement)
Sponsored by
About this trial
This is an interventional prevention trial for Stunting
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- District Pishin & Quetta
- Aga Khan University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
The control arm will receive routine public and private health services available in the area.
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.
Outcomes
Primary Outcome Measures
Reduction in stunting in children at 24 months of age
10% reduction in stunting
Secondary Outcome Measures
Improvement in anemia during pregnancy
Improvement in anemia during pregnancy
Improvement in anemia in children
Improvement in anemia in children
Reduction in low birth weight
Reduction in low birth weight in newborns
Full Information
NCT ID
NCT03689218
First Posted
September 27, 2018
Last Updated
July 19, 2021
Sponsor
Aga Khan University
Collaborators
Trust for Vaccines & Immunization (TVI), Department of Health, Government of Balochistan, World Food Program (WFP), Nutrition Cell, Government of Balochistan, Youth Organization, Balochistan
1. Study Identification
Unique Protocol Identification Number
NCT03689218
Brief Title
Evidence Generation Related to Stunting Prevention in Balochistan
Official Title
Evidence Generation Related to Stunting Prevention Through Multisectoral Approaches Coupled With Appropriate Complementary Feeding Practices in Pishin, Balochistan
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
Trust for Vaccines & Immunization (TVI), Department of Health, Government of Balochistan, World Food Program (WFP), Nutrition Cell, Government of Balochistan, Youth Organization, Balochistan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting, Low Birth Weight, Anemia in Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm will receive routine public and private health services available in the area.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maamta (Nutritious Food Supplement)
Intervention Description
Pregnant women will receive 30 sachets of Maamta during pregnancy and first six months of lactation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Wawamum (Lipid-Based Nutrient Supplement)
Intervention Description
Children 6-24 months will receive 30 sachets of Wawamum every month during the study.
Primary Outcome Measure Information:
Title
Reduction in stunting in children at 24 months of age
Description
10% reduction in stunting
Time Frame
32 months
Secondary Outcome Measure Information:
Title
Improvement in anemia during pregnancy
Description
Improvement in anemia during pregnancy
Time Frame
9 months
Title
Improvement in anemia in children
Description
Improvement in anemia in children
Time Frame
18 months
Title
Reduction in low birth weight
Description
Reduction in low birth weight in newborns
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajid B Soofi, FCPS, MBBS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Pishin & Quetta
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
87300
Country
Pakistan
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
12. IPD Sharing Statement
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Evidence Generation Related to Stunting Prevention in Balochistan
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