District-based Mainstreaming Nutrition Project in Rural Pakistan

Malnutrition Clinical Trial

— NF Nutrition  

Official title:

Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816946
• Other study ID #: 753-Ped/ERC-07
• Status: Completed
• Phase: N/A
• First received: January 2, 2009
• Last updated: January 8, 2018
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: January 2018
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the National Program for Family Planning and Primary Health Care (LHW Program) and evaluating the feasibility of scaling-up as well as the impact on birth outcomes, nutritional status, morbidity patterns and overall survival patterns at the community level.

Description:

This project aims to do the following:

• To evaluate the operational feasibility of integrating an enhanced health education and nutrition package into the existing curriculum of the National Program for FP/PHC (LHW Program)

• Impact of the implementation of the full package of evidence-based nutrition interventions on the nutrition status, morbidity patterns and overall survival patterns in the district

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Live born infants and young children from all registered pregnancies within participating villages and catchment population

• pregnant women

• Consent given by at least one of the parents

Exclusion Criteria:

• Children born with congenital malformations or serious birth injury

• Suspected non-compliance (mobile and poorly motivated parents).

• Failure to give consent

Related Conditions & MeSH terms

• Malnutrition

Intervention

Behavioral:
• Enhanced education
Enhanced Nutritional education/counseling to mothers on the following topics: During Pregnancy: diet during pregnancy; antenatal care; iron tablets; colostrum Postpartum period: difficulties during lactation; diet during lactation; EBF; childhood vaccination; newborn care Complementary Feeding General Health: vitamin A; diarrhea management; iodine; hygiene for health; protection from malaria; ARI & protection against ARI

Locations

Country	Name	City	State
Pakistan	AKU-Peds Naushero Feroze Site Office	Naushero Feroze	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	International Centre for Diarrhoeal Disease Research, Bangladesh, National Lady Health Workers Programme, Government of Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mother pregnancy weight gain in 3rd trimester		at time of enrollment, 2 weeks before delivery
Primary	mothers Hb level		at time of enrollment, 2 weeks before delivery
Primary	child's birthweight		at birth
Secondary	young child's growth		0, 3, 6, 12, 18 mths, at end of study
Secondary	dietary diversity of CF		6 mths, 9mths, 12mths, 18 mths