Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Community-based Cluster Randomized Controlled Trial to Evaluate the Effectiveness of Different Bundles of Nutrition-specific Interventions in Improving Mean Length-for-age Z Score Among Children at 24 Months of Age in Rural Bangladesh
Brief Summary: Background:

1. Burden: The prevalence of stunting among the under-five children in Bangladesh was \>55% in 1997, which reduced to 41.9% in 2011. This reduction took 14 years to achieve with existing interventions, and till today Bangladesh remains among the countries with the highest stunting prevalence.
2. Knowledge gap: In the Lancet series on Maternal and Child Nutrition, Bhutta et al (2013) modelled the effect of 10 direct interventions on lives saved and economic costs in 34 countries which contains 90% of the children with stunted growth. Their findings suggested that at 90% coverage, these interventions could cut down under-5 year mortality by 15% and avert one-fifth of stunting. The total additional annual cost was estimated at $9.6 billion. There is a dearth of primary research, however, to determine a feasible, effective bundle of interventions for developing countries.
3. Relevance: This study will review and test different sets of nutrition-specific intervention bundles in a cohort of pregnant women and the subsequent impact on the length-for-age Z score (LAZ) of their offspring from that pregnancy.

Hypothesis: Five selected nutrition-specific interventions implemented during early pregnancy and during first two years of child's life in different bundles will cause a shift of 0.4 in mean LAZ score among children at 24 months of age compared to those in comparison arm.

Methods: The investigators propose a community-based randomized trial (cRCT) to evaluate the effectiveness of different combinations of the five selected nutrition-specific interventions and identify the best combination for improving childhood LAZ. Selected interventions include prenatal nutrient supplementation; intensive counselling on prenatal nutrition, exclusive breastfeeding and timely complementary feeding; and nutrient supplementation during 6-23 months of child's age. The proposed study area is Habiganj district, Sylhet division. 125 clusters (each \~2000 population or \~450 households) will be selected from 12 homogeneous unions in 2 adjacent sub-districts. The clusters will then be randomly assigned to any one of the 5 study arms. Data would be collected at baseline and followed up, including on nutritional intake and anthropometric measurements of mothers and offspring. Primary outcome measure/variable would be mean LAZ of offspring at 24 months. Secondary outcome variables include nutritional intake during pregnancy, maternal weight gain, exclusive breast feeding up-to 6 months, and birth weight.

Implications: The investigators expect that the results will serve to inform and shape future health policy decisions related to promotion of maternal and child health.


Options:
A: Inclusion Criteria:

* All new pregnancies in the selected clusters
* Eligible woman is resident of the study area
* Gestational age ≤125 days
* Possible pregnant woman can identify her last menstrual period (LMP)

Exclusion Criteria:

* Similar nutrition interventions currently being implemented by either public or non-government agency in the selected cluster
* The cluster is too hard to reach and accessibility of the cluster is highly constrained by geographical impediments
* The cluster includes tea gardens. Communities in tea gardens comprise of unique ethnicity, culture and lifestyle for which our intervention is not customized
B: Inclusion Criteria:

* Children 0-60 months of age

Exclusion Criteria:

* None
C: Inclusion Criteria:

* Pregnant women with psychological/psychiatric problems (care level 3\*)
* Pregnant women with severe social problems, either economic or familiar (care level 3\*)
* Pregnant women from the municipality of Ballerup, Gentofte, Herlev and Rødovre

Exclusion Criteria:

* Pregnant women that exclusively has incident or chronic somatic illnesses (care level 3\*)
* Pregnant women with problems related to alcohol, drugs and/or medicine (care level 4\*)
* Pregnant women that does not speak/understand the Danish language
* Pregnant women under the age of 18
* The following diagnosis: Active eating disorder, Severe depression , Psychosis, Schizophrenia, Bipolar disorder.
D: Inclusion Criteria:

The primary study population is formed by new families, mothers and fathers and their newborn/s. Substantiated in that we are operating with a community based universal intervention with no side effects and we seek to measure the effect in a natural population we will have no exclusion criteria

Exclusion Criteria:

* except parents or infants affiliated to special treatment elsewhere.

Answer: A