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
|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Control
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.
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.
- Reduction in stunting in children at 24 months of age [ Time Frame: 32 months ]10% reduction in stunting
- Improvement in anemia during pregnancy [ Time Frame: 9 months ]Improvement in anemia during pregnancy
- Improvement in anemia in children [ Time Frame: 18 months ]Improvement in anemia in children
- Reduction in low birth weight [ Time Frame: 9 months ]Reduction in low birth weight in newborns
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689218
|Contact: Gul Nawaz Khan, MPH||02199244230 ext email@example.com|
|District Pishin & Quetta||Recruiting|
|Quetta, Balochistan, Pakistan, 87300|
|Contact: Sajid B Soofi, FCPS +92 021-34864798 ext 4798 firstname.lastname@example.org|
|Contact: Gul N Khan, MPH +92 3008298976 email@example.com|
|Aga Khan University||Recruiting|
|Karachi, Sindh, Pakistan, 74800|
|Contact: Gul Nawaz Khan, MA, MPH 2199244230 ext 8186 firstname.lastname@example.org|
|Principal Investigator:||Sajid B Soofi, FCPS, MBBS||Aga Khan University|