Maternal Education on Complementary Feeding and Infant Outcome
Condition: Growth
Study type: Interventional

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.
    

Detailed description: 
      Study population The study will be conducting in Bhainse colony (BC), Karachi. This is a
      periurban community area, and catering population mainly belonging to low - middle income
      households. The study population would be the mothers (having infant of 2.5 - 5 months of
      age) and their infants in these two study areas.

      Inclusion Criteria;

        -  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 Exclusion Criteria;

        -  Infants found below 5th percentile on weight for age CDC growth charts 23 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.

      Data outcome measures Measuring Weight, height and Mid-upper arm circumference The
      investigators measure serial height, weight and mid-upper arm circumference (MUAC) for each
      subject at enrollment and subsequently in each visit. Each infant will be measured four times
      during the study enrollment.

        -  Height will be measured twice and the results averaged. Duplicate measures that exceed
           predefined allowable variation will be resolved by the field supervisor, e.g., by
           returning to the site with the interviewer to repeat the measurements. The height of
           infants will be measured (to the nearest 0.1 cm) in the recumbent position using a board
           with a fixed head and sliding foot piece.

        -  Weight will be measured to the nearest 0.1 kg using a scale that is calibrated daily.

        -  MUAC will be measure twice each time by using measuring tape. All anthropometric
           measurements will be taken three times (in each visit) and the mean of the measurements
           will counted as valid value. Each of the anthropometric indices will be expressed in
           standard deviation units (SD) from the median of the NCHS/CDC/WHO International
           Reference Population. Methods are adapted from How to Weigh and Measure Children:
           Assessing the Nutritional Status of Young Children in Household Surveys, United Nations
           Department of Technical Cooperation for Development and Statistical Office, 1986. The
           height and weight measurements will later converted into WAZ, WHZ and HAZ score and the
           difference in both groups will be analyzed.

             -  ARI will be measured through standard IMCI guidelines. ARI could be assess by the
                physician's visit and treatment prescribed.
    

Intervention name(s): Maternal education on complementary feeding; Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; Maternal education on complementary food
Other intervention name(s): Packaged teaching education to mothers on different visits; Education to mothers given in three teaching modules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Maternal education; Complementary food; Infant growth