District-Based Mainstreaming Nutrition Project in Rural Pakistan - Full Text View

Sponsors and Collaborators:	Aga Khan University ICDDR, B 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

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:	Prevention, Non-Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
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:

MedlinePlus related topics: Diets

U.S. FDA Resources

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 ]

Estimated Enrollment:	3000
Study Start Date:	July 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Routine LHW Advice: No Intervention 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.
Enhanced LHW Advice: Active Comparator 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

Arms

Assigned Interventions

Routine LHW Advice: No Intervention

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.

Enhanced LHW Advice: Active Comparator

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

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

Locations

Pakistan, Sindh
AKU-Peds Naushero Feroze Site Office	Recruiting
Naushero Feroze, Sindh, Pakistan
Contact: Zulfiqar A Bhutta, MD, PhD 4930051 ext 4782 zulfiqar.bhutta@aku.edu
Principal Investigator: Zulfiqar A Bhutta, MD, PhD

Sponsors and Collaborators

Aga Khan University

ICDDR, B

The National Programme of Family Planning and Primary Health Care(Lady Health Worker

Programme), Government of Pakistan

More Information

No publications provided

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

Keywords provided by Aga Khan University:

malnutrition
growth

Study placed in the following topic categories:

Retinol
Malnutrition
Retinol palmitate
Vitamin A

Vitamins
Iodine
Nutrition Disorders
Iron

Additional relevant MeSH terms:

Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 02, 2009