Evidence Generation Related to Stunting Prevention in Balochistan

Sponsor
Aga Khan University (Other)
Overall Status
Completed
CT.gov ID
NCT03689218
Collaborator
Trust for Vaccines & Immunization (TVI) (Other), Department of Health, Government of Balochistan (Other), World Food Program (WFP) (Other), Nutrition Cell, Government of Balochistan (Other), Youth Organization, Balochistan (Other)
2,180
2
2
27.5
1090
39.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Maamta (Nutritious Food Supplement)
  • Dietary Supplement: Wawamum (Lipid-Based Nutrient Supplement)
N/A

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

Study Type:
Interventional
Actual Enrollment :
2180 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 Feeding Practices in Pishin, Balochistan
Actual Study Start Date :
Aug 15, 2018
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Reduction in stunting in children at 24 months of age [32 months]

    10% reduction in stunting

Secondary Outcome Measures

  1. Improvement in anemia during pregnancy [9 months]

    Improvement in anemia during pregnancy

  2. Improvement in anemia in children [18 months]

    Improvement in anemia in children

  3. Reduction in low birth weight [9 months]

    Reduction in low birth weight in newborns

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 District Pishin & Quetta Quetta Balochistan Pakistan 87300
2 Aga Khan University Karachi Sindh Pakistan 74800

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
  • Youth Organization, Balochistan

Investigators

  • Principal Investigator: Sajid B Soofi, FCPS, MBBS, Aga Khan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier:
NCT03689218
Other Study ID Numbers:
  • Stunting Study Balochistan
First Posted:
Sep 28, 2018
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
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:

Study Results

No Results Posted as of Jul 23, 2021