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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 2, 2009
Last Updated Date	August 9, 2011
Start Date ^ICMJE	July 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 2, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00816946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 2, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	District-based Mainstreaming Nutrition Project in Rural Pakistan
Official Title ^ICMJE	Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh
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.
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Malnutrition
Intervention ^ICMJE	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. 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
Study Arm (s)	No Intervention: Routine LHW Advice Arm receiving routine advice by their local Lady Health Workers (LHWs) Intervention: Behavioral: Routine advice Active Comparator: Enhanced LHW Advice Arm receiving enhanced nutrition and health advice from the local Lady Health Workers (LHWs)during their routine community visits. Intervention: Behavioral: Enhanced education
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	3000
Completion Date	February 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Pakistan

Administrative Information
NCT Number ^ICMJE	NCT00816946
Other Study ID Numbers ^ICMJE	753-Ped/ERC-07
Has Data Monitoring Committee	No
Responsible Party	Zulfiqar Ahmed Bhutta / Chair & Professor, Dept of Paediatrics and Child Health, Aga Khan University
Study Sponsor ^ICMJE	Aga Khan University
Collaborators ^ICMJE	International Centre for Diarrhoeal Disease Research, Bangladesh The National Programme of Family Planning and Primary Health Care(Lady Health Worker Programme), Government of Pakistan
Investigators ^ICMJE	Not Provided
Information Provided By	Aga Khan University
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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