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

This study has been completed.
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
The National Programme of Family Planning and Primary Health Care(Lady Health Worker
Programme), Government of Pakistan
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
NCT00816946
First received: January 2, 2009
Last updated: August 9, 2011
Last verified: January 2009
  Purpose

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 Intervention
Malnutrition
Behavioral: Routine advice
Behavioral: Enhanced education

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • mother pregnancy weight gain in 3rd trimester [ Time Frame: at time of enrollment, 2 weeks before delivery ] [ Designated as safety issue: No ]
  • mothers Hb level [ Time Frame: at time of enrollment, 2 weeks before delivery ] [ Designated as safety issue: No ]
  • child's birthweight [ Time Frame: at birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • young child's growth [ Time Frame: 0, 3, 6, 12, 18 mths, at end of study ] [ Designated as safety issue: No ]
  • dietary diversity of CF [ Time Frame: 6 mths, 9mths, 12mths, 18 mths ] [ Designated as safety issue: No ]

Enrollment: 3000
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Routine LHW Advice
Arm receiving routine advice by their local Lady Health Workers (LHWs)
Behavioral: Routine advice
Routine advice to mother and/or other key care provider by the local Lady Health Workers (LHWs)during her routine community visits.
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


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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816946

Locations
Pakistan
AKU-Peds Naushero Feroze Site Office
Naushero Feroze, Sindh, Pakistan
Sponsors and Collaborators
Aga Khan University
International Centre for Diarrhoeal Disease Research, Bangladesh
The National Programme of Family Planning and Primary Health Care(Lady Health Worker
Programme), Government of Pakistan
  More Information

No publications provided

Responsible Party: Zulfiqar Ahmed Bhutta / Chair & Professor, Dept of Paediatrics and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT00816946     History of Changes
Other Study ID Numbers: 753-Ped/ERC-07
Study First Received: January 2, 2009
Last Updated: August 9, 2011
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
malnutrition
growth

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 26, 2014