Evidence Generation Related to Stunting Prevention in Balochistan

NCT03689218 | Completed DMC

• 1 other identifier: Stunting Study Balochistan
• Study Type: interventional
• Target: 2,180
• Locations: 1 country
• Sites: 2

Brief Summary

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 project will utilize the window of opportunity (1000 days from conception to 2 years) for addressing stunting in children under-two years. Therefore project will recruit pregnant women during first trimester and newborns who delivered from recruited pregnant women will be followed until the age of 2 years. Children 6-12 months of age will be enrolled and followed until the age of two years. The interventions included nutritional supplements during pregnancy, lactation and for children during 6-24 months of age. The project will be implemented in Lady Health Workers (LHWs) covered areas of districts Pishin and Quetta, Balochistan.

Conditions

Stunting; Low Birth Weight; Anemia in Pregnancy

Outcome Measures

Primary Outcomes (1)

• Reduction in stunting in children at 24 months of age

  10% reduction in stunting

  32 months

Secondary Outcomes (3)

• Improvement in anemia during pregnancy

  9 months

• Improvement in anemia in children

  18 months

• Reduction in low birth weight

  9 months

Study Arms (2)

Control

NO INTERVENTION

The control arm will receive routine public and private health services available in the area.

Intervention

EXPERIMENTAL

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); Dietary Supplement: Wawamum (Lipid-Based Nutrient Supplement)

Interventions

Maamta (Nutritious Food Supplement) DIETARY_SUPPLEMENT

Pregnant women will receive 30 sachets of Maamta during pregnancy and first six months of lactation.

Intervention

Wawamum (Lipid-Based Nutrient Supplement) DIETARY_SUPPLEMENT

Children 6-24 months will receive 30 sachets of Wawamum every month during the study.

Intervention

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pregnant women during 1-3 months of pregnancy
• Child age between 6-12 month at the time of enrollment
• Willing to participate in the study and provide informed consent
• Living in catchment area of LHW

You may not qualify if:

• More than 4 months of pregnancy
• More than 12 months of child age
• Not willing to participate in the study and unable provide informed consent
• Not living in catchment area of LHW

Sponsors & Collaborators

• Aga Khan University: lead
• Trust for Vaccines & Immunization (TVI): collaborator
• Department of Health, Government of Balochistan: collaborator
• World Food Program (WFP): collaborator
• Nutrition Cell, Government of Balochistan: collaborator
• Youth Organization, Balochistan: collaborator

Study Sites (2)

District Pishin & Quetta

Quetta, Balochistan, 87300, Pakistan

Location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sajid B Soofi, FCPS, MBBS

  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: September 27, 2018
• First Posted: September 28, 2018
• Study Start: August 15, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

PA (2)