Evidence Generation Related to Stunting Prevention in Balochistan

Stunting Clinical Trial

Official title:

Evidence Generation Related to Stunting Prevention Through Multisectoral Approaches Coupled With Appropriate Complementary Feeding Practices in Pishin, Balochistan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689218
• Other study ID #: Stunting Study Balochistan
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2180
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia in Pregnancy
• Birth Weight
• Growth Disorders
• Low Birth Weight
• Stunting

Intervention

Dietary Supplement:
• Maamta (Nutritious Food Supplement)
Pregnant women will receive 30 sachets of Maamta during pregnancy and first six months of lactation.
• Wawamum (Lipid-Based Nutrient Supplement)
Children 6-24 months will receive 30 sachets of Wawamum every month during the study.

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh
Pakistan	District Pishin & Quetta	Quetta	Balochistan

Sponsors (6)

Lead Sponsor	Collaborator
Aga Khan University	Department of Health, Government of Balochistan, Nutrition Cell, Government of Balochistan, Trust for Vaccines & Immunization (TVI), World Food Program (WFP), Youth Organization, Balochistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in stunting in children at 24 months of age	10% reduction in stunting	32 months
Secondary	Improvement in anemia during pregnancy	Improvement in anemia during pregnancy	9 months
Secondary	Improvement in anemia in children	Improvement in anemia in children	18 months
Secondary	Reduction in low birth weight	Reduction in low birth weight in newborns	9 months