Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

Study Overview
=================
Brief Summary
-----------------
The prevention of malnutrition among children under 5 years of age requires consumption of nutritious food, including exclusive breast feeding for the first six months of life, followed by breastfeeding in combination with complementary foods thereafter until at least 24 months of age; a hygienic environment; access to preventive as well as curative health services, and good prenatal care. The proposed research is on the possible options for providing a nutritious diet, realizing the constraints of poverty and food insecurity faced by care givers whose children are at risk of developing or confirmed to be suffering from moderate malnutrition. Even when people are not typically food insecure but consume a relatively monotonous diet with few good-quality foods, they also have to have options for dietary improvement, and especially the possibility of ready-to-use complementary food supplements (RUCFS) for young children. This proposed research on development of RUCFS will pave the way for programmatic considerations for expansion of the use of new complementary food supplements for preventing malnutrition among young children in Bangladesh.

Official Title
-----------------
Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh

Conditions
-----------------
Moderately Malnourished Children

Intervention / Treatment
-----------------
* Dietary Supplement: Pushti packet
* Dietary Supplement: Rice based Ready to Use Complementary Food Supplements
* Dietary Supplement: Chick-pea based Ready to Use Complementary Food Supplements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 to 18 months; either sex, having no acute illness, and be on at least one semi-solid or solid food in a day. Exclusion Criteria: loss of appetite, oral lesion, congenital anomaly/acquired disorder affecting growth, severe acute malnutrition (SAM) defined by: MUAC < 115 mm or WL < -3 Z score or bipedal edema, persistent diarrhea, tuberculosis, any other chronic illness.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pushti Packet<br> | Dietary Supplement: Pushti packet<br>* A food composed of roasted rice, roasted lentil, molasses and soybean oil<br>* Other names: A food composed of roasted rice, roasted lentil, molasses and soybean oil;|
| Experimental: Rice based Ready to Use Complementary Food Supplements<br> | Dietary Supplement: Rice based Ready to Use Complementary Food Supplements<br>* A rice based diet.<br>|
| Active Comparator: Chick-pea based Ready to Use Complementary Food Supplements<br> | Dietary Supplement: Chick-pea based Ready to Use Complementary Food Supplements<br>* A chick-pea based diet.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of at least one Ready -to-Use Complementary Food supplement | At least one of the experimental Ready -to-Use Complementary Food supplement will be acceptable to the study participants for prevention of malnutrition. The acceptability will be assessed by a 7-point Hedonic scale. | 7 days |