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District-based Mainstreaming Nutrition Project in Rural Pakistan (NF Nutrition)

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ClinicalTrials.gov Identifier: NCT00816946
Recruitment Status : Completed
First Posted : January 5, 2009
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Malnutrition Behavioral: Enhanced education

Detailed 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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : July 2008
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Routine LHW Advice
Arm receiving routine advice by their local Lady Health Workers (LHWs)
Active Comparator: Enhanced LHW Advice
Arm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits.
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

Outcome Measures

Primary Outcome Measures :
  1. mother pregnancy weight gain in 3rd trimester [ Time Frame: at time of enrollment, 2 weeks before delivery ]
  2. mothers Hb level [ Time Frame: at time of enrollment, 2 weeks before delivery ]
  3. child's birthweight [ Time Frame: at birth ]

Secondary Outcome Measures :
  1. young child's growth [ Time Frame: 0, 3, 6, 12, 18 mths, at end of study ]
  2. dietary diversity of CF [ Time Frame: 6 mths, 9mths, 12mths, 18 mths ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816946

AKU-Peds Naushero Feroze Site Office
Naushero Feroze, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
International Centre for Diarrhoeal Disease Research, Bangladesh
National Lady Health Workers Programme, Government of Pakistan
More Information

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Director, Centre of Excellence in Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT00816946     History of Changes
Other Study ID Numbers: 753-Ped/ERC-07
First Posted: January 5, 2009    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:

Additional relevant MeSH terms:
Nutrition Disorders