NCT02422953

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,020

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

3.9 years

First QC Date

April 15, 2015

Last Update Submit

November 13, 2019

Conditions

Malnutrition

Keywords

StuntingWastingUnderweight

Outcome Measures

Primary Outcomes (1)

  • Stunting-reduction in stunted children in intervention group

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

    2 Years

Secondary Outcomes (14)

  • Pregnancy out come

    2 Years

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

    2 Years

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

    2 Years

  • Improvement in infant and young child feeding (IYCF) indicators

    2 Years

  • Linear growth velocity (HAZ increment/month)

    2 Years

  • +9 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Wheat Soya Blend (WSB)Dietary Supplement: Wawa MumDietary Supplement: Micronutrient Powders (MNP)Behavioral: Behavior change and preventive health massages

Control

NO INTERVENTION

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

Interventions

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

Intervention
Wawa MumDIETARY_SUPPLEMENT

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

Intervention
Micronutrient Powders (MNP)DIETARY_SUPPLEMENT

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

Intervention
Behavior change and preventive health massagesBEHAVIORAL

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

Intervention

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (9)

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

  • Soofi SB, Khan GN, Ariff S, Ihtesham Y, Tanimoune M, Rizvi A, Sajid M, Garzon C, de Pee S, Bhutta ZA. Effectiveness of nutritional supplementation during the first 1000-days of life to reduce child undernutrition: A cluster randomized controlled trial in Pakistan. Lancet Reg Health Southeast Asia. 2022 Jul 19;4:100035. doi: 10.1016/j.lansea.2022.100035. eCollection 2022 Sep.

    PMID: 37383995DERIVED

  • 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.

    PMID: 32790725DERIVED

  • 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.

    PMID: 32616009DERIVED

  • 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.

    PMID: 28056945DERIVED

MeSH Terms

Conditions

MalnutritionGrowth DisordersCachexiaThinness

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and Symptoms

Study Officials

  • Sajid B Soofi, FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 15, 2015

First Posted

April 22, 2015

Study Start

August 1, 2014

Primary Completion

June 30, 2018

Study Completion

September 30, 2018

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Data are sharing with funding agency on 6-monthly basis

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
As per the project deliverables
Access Criteria
Review and feedback
More information

Locations

PA(1)