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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Wheat Soya Blend (WSB)
Wawa Mum
Micronutrient Powders (MNP)
Behavior change and preventive health massages
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Stunting, Wasting, Underweight

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Wheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages

Control group will receive routine public and private health services available in the area.

Outcomes

Primary Outcome Measures

Stunting-reduction in stunted children in intervention group
To calculate HAZ scores the 2006 WHO growth reference will be used

Secondary Outcome Measures

Pregnancy out come
Reduction in low birth weight in newborns
Mean change in weight-for-height z-score (WHZ)
To calculate WHZ scores the 2006 WHO growth reference will be used
Mean change in weight-for-age z-score (WAZ)
To calculate WAZ scores the 2006 WHO growth reference will be used
Improvement in infant and young child feeding (IYCF) indicators
Monthly data collection on IYCF practices
Linear growth velocity (HAZ increment/month)
To calculate HAZ score the 2006 WHO growth reference will be used
Mean hemoglobin concentration in children 6-59 months of age
Hemocue will be used to measure Hb concentration
Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age
Hb spot testing will be conducted
Mean hemoglobin concentration in mothers
Hemocue will be used to measure Hb concentration
Prevalence of maternal anemia (Hb concentration<12g/dL)
Hb spot testing will be conducted
Impact on maternal BMI
The change in BMI z-score weight and height will be combined to report BMI in kg/m^2
Impact on vitamin A status in children at 24 months
The change in Vitamin A status (µmol/L) in children at 24 months of age
Impact on vitamin D status in children at 24 months
The change in vitamin D status (ng/mL) in children at 24 months of age
Impact on Zinc status in children at 24 months
The change in Zinc status (µg/dL) in children at 24 months of age
Impact on Ferritin status in children at 24 months
The change in Ferritin status (ng/mL) in children at 24 months of age

Full Information

First Posted
April 15, 2015
Last Updated
November 13, 2019
Sponsor
Aga Khan University
Collaborators
United Nations World Food Programme (WFP), Pakistan Ministry of Health
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1. Study Identification

Unique Protocol Identification Number
NCT02422953
Brief Title
Stunting Prevention Project in Thatta and Sujawal Districts, Sindh Province, Pakistan
Official Title
Effectiveness of Food/Nutrient Based Interventions to Prevent Stunting Among Children Under Five in Thatta and Sujawal Districts, Sindh Province, Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
United Nations World Food Programme (WFP), Pakistan Ministry of Health

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Stunting, Wasting, Underweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4020 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Wheat Soya Blend, Wawa Mum, Micronutrient Powders, Behavior change and preventive health massages
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will receive routine public and private health services available in the area.
Intervention Type
Dietary Supplement
Intervention Name(s)
Wheat Soya Blend (WSB)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Wawa Mum
Intervention Description
Children 6-23 months of age will receive a daily ration of 50 gram of Wawa Mum during study period
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient Powders (MNP)
Intervention Description
Children 24-59 months of age will receive a sachet of Micronutrient Powders (MNP) in alternate days
Intervention Type
Behavioral
Intervention Name(s)
Behavior change and preventive health massages
Intervention Description
Behavior change and preventive health massages will be delivered by lady health workers (LHWs) during monthly visits and in group meetings
Primary Outcome Measure Information:
Title
Stunting-reduction in stunted children in intervention group
Description
To calculate HAZ scores the 2006 WHO growth reference will be used
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Pregnancy out come
Description
Reduction in low birth weight in newborns
Time Frame
2 Years
Title
Mean change in weight-for-height z-score (WHZ)
Description
To calculate WHZ scores the 2006 WHO growth reference will be used
Time Frame
2 Years
Title
Mean change in weight-for-age z-score (WAZ)
Description
To calculate WAZ scores the 2006 WHO growth reference will be used
Time Frame
2 Years
Title
Improvement in infant and young child feeding (IYCF) indicators
Description
Monthly data collection on IYCF practices
Time Frame
2 Years
Title
Linear growth velocity (HAZ increment/month)
Description
To calculate HAZ score the 2006 WHO growth reference will be used
Time Frame
2 Years
Title
Mean hemoglobin concentration in children 6-59 months of age
Description
Hemocue will be used to measure Hb concentration
Time Frame
2 Years
Title
Prevalence of childhood anemia (Hb concentration<11g/dL) in children 6-59 months of age
Description
Hb spot testing will be conducted
Time Frame
2 Years
Title
Mean hemoglobin concentration in mothers
Description
Hemocue will be used to measure Hb concentration
Time Frame
2 Years
Title
Prevalence of maternal anemia (Hb concentration<12g/dL)
Description
Hb spot testing will be conducted
Time Frame
2 Years
Title
Impact on maternal BMI
Description
The change in BMI z-score weight and height will be combined to report BMI in kg/m^2
Time Frame
2 Years
Title
Impact on vitamin A status in children at 24 months
Description
The change in Vitamin A status (µmol/L) in children at 24 months of age
Time Frame
2 Years
Title
Impact on vitamin D status in children at 24 months
Description
The change in vitamin D status (ng/mL) in children at 24 months of age
Time Frame
2 Years
Title
Impact on Zinc status in children at 24 months
Description
The change in Zinc status (µg/dL) in children at 24 months of age
Time Frame
2 Years
Title
Impact on Ferritin status in children at 24 months
Description
The change in Ferritin status (ng/mL) in children at 24 months of age
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajid B Soofi, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are sharing with funding agency on 6-monthly basis
IPD Sharing Time Frame
As per the project deliverables
IPD Sharing Access Criteria
Review and feedback
IPD Sharing URL
https://www.wfp.org
Citations:
Citation
National Nutrition Survey (NNS), 2011. Planning Commission Planning and Development Division Government of Pakistan.
Results Reference
background
Citation
WFP (2012): Protracted Relief and Recovery Operations (PRRO). Pakistan 200250. Rome, Italy.
Results Reference
background
Citation
Horton, S. Opportunities for investments in nutrition in low-income Asia; 1999. Asian Development Review 17 (1, 2): 246-273.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Donner, A. and Klar, N. Design and Analysis of Cluster Randomization Trials in Health Research. Arnold, London; 2000
Results Reference
background
PubMed Identifier
32790725
Citation
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.
Results Reference
derived
PubMed Identifier
32616009
Citation
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.
Results Reference
derived
PubMed Identifier
28056945
Citation
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.
Results Reference
derived

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

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