Maternal Education on Complementary Feeding and Infant Outcome

NCT01128517 | Completed

• 1 other identifier: MECF
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

Overall Objective

• To evaluate impact of maternal educational strategies (teaching sessions by trained lady health workers, verbal, pictorial and demonstrative) regarding appropriate complementary foods of infants, and assess their impact on nutritional status of after six months of educational intervention. Specific objective • To determine the impact of maternal educational strategies regarding complementary foods by assessing baseline weight, height and mid - upper arm circumference at 2.5 - 5 month of age and then comparing it at 3, 6 and 9 months after enrollment. (Hypothesis; the investigators hypothesize that there will be a gain of 250 gram weight, 0.5 cm in length and 0.5 cm in MUAC in infants whose mothers received the special education module for complementary feeding, as compare to the children whose mothers doesn't receive education on complementary food. Secondary objective
• To determine the impact of maternal educational strategies regarding complementary foods by assessing morbidity (number of diarrhea and ARI episodes, at 2.5 - 5 month of age and at then reporting at 3, 6 and 9 months after enrollment). (Hypothesis; the investigators hypothesize that there will be 10% decrease in incidence of diarrhea episodes and ARI episodes in infants whose mother received the special education module for complementary feeding, as compare to the children whose mothers doesn't receive education on complementary food). ARI can be define as per IMCI guidelines. Increase breathing rate (age specific) along with cough, cold and or wheezing.

Conditions

Growth

Keywords

Maternal education; Complementary food; Infant growth

Outcome Measures

Primary Outcomes (1)

• Nutritional status

  Height, Weight and Mid Upper Arm circumference

  7.5 month

Secondary Outcomes (3)

• Diarrhea episodes

  7.5 months

• Z score (HAZ, WAZ and WHZ scores)

  7.5 months

• ARI

  7.5 months

Study Arms (1)

Bahavioral

EXPERIMENTAL

Education about complementary food given to mothers

Behavioral: Maternal education on complementary feeding; Behavioral: Education

Interventions

Maternal education on complementary feeding BEHAVIORAL

CF education to the mothers in intervention arm. * Ten important key messages developed based on recommended practices (WHO/UNICEF, 2000 \& 2006). * First session --\> cover the importance of breast feeding, its continuation for whole two years, hand washing, hygiene and importance of CF initiation at 6 months of age. * Second session --\>breastfeeding promotion, complementary food consistency, initial complementary food selection and age related complementary food education. * Third session --\> previous sessions recall. protein based and iron rich food encouragement. * The control arm continue to be benefited from the lady health workers program, while breastfeeding promotion would be provided to control arm

Also known as: Packaged teaching education to mothers on different visits

Bahavioral

Education BEHAVIORAL

Maternal education on complementary food

Also known as: Education to mothers given in three teaching modules.

Bahavioral

Eligibility Criteria

• Age: 3 Months - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 2.5 - 5 months; who are either exclusively breast feed or partially breast feed but have not started complementary feeding or have recently started complementary food (less than 1 week)
• Informed consent

You may not qualify if:

• Infants found below 5th percentile on weight for age CDC growth charts at baseline will be excluded
• History of two or more hospital admissions for more than 7 days each
• Presence of serious congenital anomalies (cleft palate, congenital heart disease, neural tube defect) or other chronic conditions impairing feeding (e.g. cerebral palsy)
• Presence of acute illness requiring urgent hospitalization
• Infants from families of very low socioeconomic status where adequate calorie-provision is constrained (assessed by a questionnaire on household possessions of items such as mobile phone, bicycle or other vehicle, TV, cemented construction, fuel used for cooking - wood or gas/LPG)
• Infant already enrolled in any trial with a nutritional intervention will be excluded
• Infants who at initial clinical examination are found to be severely anemic

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Bhainse colony

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ali F Saleem, MBBS

  The Aga Khan University Hospital, Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 24, 2010
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 24, 2010

Record last verified: 2010-04

Locations

PA (1)