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Evidence Generation Related to Stunting Prevention in Balochistan

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ClinicalTrials.gov Identifier: NCT03689218
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
Trust for Vaccines & Immunization (TVI)
Department of Health, Government of Balochistan
World Food Program (WFP)
Nutrition Cell, Government of Balochistan
Information provided by (Responsible Party):
Dr Sajid Bashir Soofi, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Stunting Low Birth Weight Anemia in Pregnancy Dietary Supplement: Maamta (Nutritious Food Supplement) Dietary Supplement: Wawamum (Lipid-Based Nutrient Supplement) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evidence Generation Related to Stunting Prevention Through Multisectoral Approaches Coupled With Appropriate Complementary Practices in Pishin, Balochistan
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders

Arm Intervention/treatment
No Intervention: Control
The control arm will receive routine public and private health services available in the area.
Experimental: Intervention
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.
Dietary Supplement: Maamta (Nutritious Food Supplement)
Pregnant women will receive 30 sachets of Maamta during pregnancy and first six months of lactation.

Dietary Supplement: Wawamum (Lipid-Based Nutrient Supplement)
Children 6-24 months will receive 30 sachets of Wawamum every month during the study.




Primary Outcome Measures :
  1. Reduction in stunting in children at 24 months of age [ Time Frame: 32 months ]
    10% reduction in stunting


Secondary Outcome Measures :
  1. Improvement in anemia during pregnancy [ Time Frame: 9 months ]
    Improvement in anemia during pregnancy

  2. Improvement in anemia in children [ Time Frame: 18 months ]
    Improvement in anemia in children

  3. Reduction in low birth weight [ Time Frame: 9 months ]
    Reduction in low birth weight in newborns



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689218


Contacts
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Contact: Gul Nawaz Khan, MPH 02199244230 ext 8186 gul.nawaz@aku.edu

Locations
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Pakistan
District Pishin & Quetta Recruiting
Quetta, Balochistan, Pakistan, 87300
Contact: Sajid B Soofi, FCPS    +92 021-34864798 ext 4798    sajid.soofi@aku.edu   
Contact: Gul N Khan, MPH    +92 3008298976    gul.nawaz@aku.edu   
Aga Khan University Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Gul Nawaz Khan, MA, MPH    2199244230 ext 8186    gul.nawaz@aku.edu   
Sponsors and Collaborators
Aga Khan University
Trust for Vaccines & Immunization (TVI)
Department of Health, Government of Balochistan
World Food Program (WFP)
Nutrition Cell, Government of Balochistan
Investigators
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Principal Investigator: Sajid B Soofi, FCPS, MBBS Aga Khan University
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Responsible Party: Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03689218    
Other Study ID Numbers: Stunting Study Balochistan
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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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
Additional relevant MeSH terms:
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Birth Weight
Growth Disorders
Body Weight
Pathologic Processes
Nutrients
Growth Substances
Physiological Effects of Drugs