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

• ClinicalTrials.gov Identifier: NCT02422953
• Recruitment Status: Completed
• First Posted: April 22, 2015
• Last Update Posted: November 15, 2019
• Sponsor: Aga Khan University
• Collaborators: United Nations World Food Programme (WFP); Pakistan Ministry of Health
• Information provided by (Responsible Party): Dr Sajid Bashir Soofi, Aga Khan University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Malnutrition	Dietary Supplement: Wheat Soya Blend (WSB); Dietary Supplement: Wawa Mum; Dietary Supplement: Micronutrient Powders (MNP); Behavioral: Behavior change and preventive health massages	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4020 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan
• Actual Study Start Date: August 2014
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: September 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Wheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages	Dietary Supplement: Wheat Soya Blend (WSB); 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; Dietary Supplement: Wawa Mum; Children 6-23 months of age will receive a daily ration of 50 gram of Wawa Mum during study period; Dietary Supplement: Micronutrient Powders (MNP); Children 24-59 months of age will receive a sachet of Micronutrient Powders (MNP) in alternate days; Behavioral: Behavior change and preventive health massages; Behavior change and preventive health massages will be delivered by lady health workers (LHWs) during monthly visits and in group meetings
No Intervention: Control; Control group will receive routine public and private health services available in the area.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 59 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Pakistan

Aga Khan University

Karachi, Sindh, Pakistan, 74800

Sponsors and Collaborators

Aga Khan University

United Nations World Food Programme (WFP)

Pakistan Ministry of Health

Investigators

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

More Information

Publications:

National Nutrition Survey (NNS), 2011. Planning Commission Planning and Development Division Government of Pakistan.

WFP (2012): Protracted Relief and Recovery Operations (PRRO). Pakistan 200250. Rome, Italy.

Horton, S. Opportunities for investments in nutrition in low-income Asia; 1999. Asian Development Review 17 (1, 2): 246-273.

Gorstein J, Sullivan KM, Parvanta I, Begin F. Indicators and Methods for Cross-Sectional Surveys of Vitamin and Mineral Status of Populations. The Micronutrient Initiative (Ottawa) and the Centers for Disease Control and Prevention (Atlanta), May 2007.

Donner, A. and Klar, N. Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London; 2000

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Khan GN, Kureishy S, Ariff S, Rizvi A, Sajid M, Garzon C, Khan AA, de Pee S, Soofi SB, Bhutta ZA. Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial. PLoS One. 2020 Aug 13;15(8):e0237210. doi: 10.1371/journal.pone.0237210. eCollection 2020.

Zaidi S, Das JK, Khan GN, Najmi R, Shah MM, Soofi SB. Food supplements to reduce stunting in Pakistan: a process evaluation of community dynamics shaping uptake. BMC Public Health. 2020 Jul 2;20(1):1046. doi: 10.1186/s12889-020-09103-8.

Kureishy S, Khan GN, Arrif S, Ashraf K, Cespedes A, Habib MA, Hussain I, Ullah A, Turab A, Ahmed I, Zaidi S, Soofi SB. A mixed methods study to assess the effectiveness of food-based interventions to prevent stunting among children under-five years in Districts Thatta and Sujawal, Sindh Province, Pakistan: study protocol. BMC Public Health. 2017 Jan 5;17(1):24. doi: 10.1186/s12889-016-3976-y.

• Responsible Party: Dr Sajid Bashir Soofi, Associate Professor, Aga Khan University
• ClinicalTrials.gov Identifier: NCT02422953
• Other Study ID Numbers: WFP-Thatta
• First Posted: April 22, 2015
• Last Update Posted: November 15, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data are sharing with funding agency on 6-monthly basis
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: As per the project deliverables
• Access Criteria: Review and feedback
• URL: https://www.wfp.org

Keywords provided by Dr Sajid Bashir Soofi, Aga Khan University:

Stunting; Wasting; Underweight

Additional relevant MeSH terms:

Malnutrition; Growth Disorders; Nutrition Disorders; Pathologic Processes; Micronutrients; Trace Elements; Physiological Effects of Drugs