Clinical trial NCT01128517: Maternal Education on Complementary Feeding and Infant Outcome
Official title: Does Maternal Education on Complementary Feeding Have an Impact on Infant Nutritional Status in Low Middle-income Households? A Community Based Randomized Interventional Study in Karachi, Pakistan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Keywords: Maternal education
Complementary food
Infant growth
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2010-05-24
Enrollment: 175
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Nutritional status
timeFrame: 7.5 month
Secondary outcomes:
measure: Diarrhea episodes
timeFrame: 7.5 months
measure: Z score (HAZ, WAZ and WHZ scores)
timeFrame: 7.5 months
measure: ARI
timeFrame: 7.5 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Bhainse colony
state: Sindh
Study officials:
affiliation: The Aga Khan University Hospital, Karachi, Pakistan
name: Ali F Saleem, MBBS
role: PRINCIPAL_INVESTIGATOR
References: