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NCT Number: NCT02422953

Stunting Prevention Project in Thatta and Sujawal Districts, Sindh Province, Pakistan

Widespread food insecurity and malnutrition are largely the main impairing factors for human capital development in Pakistan. Rates of chronic malnutrition are very high, and acute malnutrition is critical: 44% of children under five are stunted and nationwide global acute malnutrition (GAM) rates amongst children under five exceed the WHO critical threshold of 15%. Nutritional status trends also show a deteriorating situation since 1994, when stunting rates were at 36%.

This study evaluates the effectiveness of food based interventions to prevent stunting among children under-five years with focus on window of opportunity (1000 days from conception to 2 years) for addressing stunting. Pregnant women, lactating mothers and children 6-59 months will receive supplements on monthly basis in intervention areas, while participants in control areas will receive routine public health services available in the study area.

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Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

Children under two are consuming less than half of their daily energy requirements (560 kcal) and lower than recommended levels of micronutrients (one-third of reference nutrient intake for Iron and one-half for Zinc). Overall, less than 4% of children were receiving an acceptable, diverse diet. Food security and nutrition situation in Sindh province is even more dramatic. According to the National Nutrition Survey, 2011, GAM prevalence exceeds 18% while anemia levels amongst children under five reached the alarming level of 72.5%. With this high level of poverty and food insecurity, a food based approach to prevent stunting, together with non- food based approaches is needed.

Therefore, Division of Women and Child Health, Aga Khan University proposes a research study for stronger evidence base on the effectiveness of preventive food/nutrient based interventions on reduction of stunting and developing viable programmes on nutrition under "real" operational conditions. The effectiveness of the project will be measured in terms of the impact of the proposed interventions on the stunting and micronutrient deficiency prevalences in the target group (children and mothers). Given the conditions of project implementation, a quasi-experimental "double difference" design would be appropriate to assess the impact of the intervention. We propose to compare the intervention and non-intervention (control) groups before (first difference) and after the intervention (second difference). Then, the operational implementation of the research comprises a baseline and end line surveys. In addition, a nested cluster randomized controlled trial will be implemented to track the evolution of key variables related to the quality of intervention delivery and intermediate nutrition outcomes. The control clusters will receive routine public and private health services available in the area.

To achieve its purpose and objectives the project design includes core interventions such as complementary feeding using food/nutrient based supplements along with behavior change communication, complemented with other non-food interventions. Using a preventative (blanket) approach, three types of food/nutrient supplements (Wawamum, MNP & WSB) are considered as part of the interventions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pregnant women
  • All lactating mothers (upto 6 months)
  • All children 6-23 months of age
  • All children 24-59 months of age

Exclusion criteria

  • Refuse to participate in the study
  • Having severe chronic disease

Treatment and study plan

Wheat Soya Blend (WSB)

Dietary Supplement

A monthly ration of 5 Kg of Wheat Soya Blend (WSB) will be given to pregnant women every month during pregnancy and lactating mothers for six months after giving birth

Wawa Mum

Dietary Supplement

Children 6-23 months of age will receive a daily ration of 50 gram of Wawa Mum during study period

Micronutrient Powders (MNP)

Dietary Supplement

Children 24-59 months of age will receive a sachet of Micronutrient Powders (MNP) in alternate days

Behavior change and preventive health massages

Behavioral

Behavior change and preventive health massages will be delivered by lady health workers (LHWs) during monthly visits and in group meetings

Primary outcomes

  1. Stunting-reduction in stunted children in intervention group

    Time frame: 2 Years

    To calculate HAZ scores the 2006 WHO growth reference will be used

Secondary outcomes

  1. Pregnancy out come

    Time frame: 2 Years

    Reduction in low birth weight in newborns

  2. Mean change in weight-for-height z-score (WHZ)

    Time frame: 2 Years

    To calculate WHZ scores the 2006 WHO growth reference will be used

  3. Mean change in weight-for-age z-score (WAZ)

    Time frame: 2 Years

    To calculate WAZ scores the 2006 WHO growth reference will be used

  4. Improvement in infant and young child feeding (IYCF) indicators

    Time frame: 2 Years

    Monthly data collection on IYCF practices

  5. Linear growth velocity (HAZ increment/month)

    Time frame: 2 Years

    To calculate HAZ score the 2006 WHO growth reference will be used

  6. Mean hemoglobin concentration in children 6-59 months of age

    Time frame: 2 Years

    Hemocue will be used to measure Hb concentration

  7. Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age

    Time frame: 2 Years

    Hb spot testing will be conducted

  8. Mean hemoglobin concentration in mothers

    Time frame: 2 Years

    Hemocue will be used to measure Hb concentration

  9. Prevalence of maternal anemia (Hb concentration<12g/dL)

    Time frame: 2 Years

    Hb spot testing will be conducted

  10. Impact on maternal BMI

    Time frame: 2 Years

    The change in BMI z-score weight and height will be combined to report BMI in kg/m^2

  11. Impact on vitamin A status in children at 24 months

    Time frame: 2 Years

    The change in Vitamin A status (µmol/L) in children at 24 months of age

  12. Impact on vitamin D status in children at 24 months

    Time frame: 2 Years

    The change in vitamin D status (ng/mL) in children at 24 months of age

  13. Impact on Zinc status in children at 24 months

    Time frame: 2 Years

    The change in Zinc status (µg/dL) in children at 24 months of age

  14. Impact on Ferritin status in children at 24 months

    Time frame: 2 Years

    The change in Ferritin status (ng/mL) in children at 24 months of age

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Pakistan Ministry of Health
  • United Nations World Food Programme (WFP)

Registry information

Official study title

Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 22, 2015
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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