Improving Linear Growth of Children in Low Resource Settings through Integrated Nutrition, Health, WASH, Care and Support Interventions during the Pre- and Peri-conceptional Period, Pregnancy and Early Childhood - A Randomized Controlled Trial

The study will be conducted in urban neighbourhoods in South Delhi.Prior to selection of the population, a survey was conducted to ascertainstunting and wasting rates in undertwos.

In this study, married women aged 18 to 30 years, with no or one child,living with her husband, who consent for participation, will be enrolled andfollowed up till they become pregnant or have completed 18 months of follow up.Once a woman is confirmed to be pregnant, she will be consented again for herand her infant’s participation in the trial.

Once enrolled, the intervention group women will be visited by differentteams. Women diagnosed with medical conditions that affect growth of thefetus and young children will be referred to Safdarjung Hospital formanagement. Women diagnosed with anemia or undernutrition will be treatedaccording to the government guidelines. They will also be counselled onpersonal and menstrual hygiene and assisted to deal with stressful conditionsthrough a positive frame of mind. The women in control group will continue toavail routine standard care as per National Programs.

Once women are pregnant, consent will be sought for their, and theirinfants participation in the trial.

During pregnancy, women in the intervention group will be encouraged forregular antenatal follow up in Safdarjung Hospital and counselled aboutbenefits of diets consisting of adequate energy, protein, vitamins and mineralsobtained from a variety of locally available foods. To account for theadditional requirement of energy during pregnancy, food supplements would alsobe provided. In the postnatal period and early childhood, women will beencouraged to go for postnatal visits. Women will be counselled for exclusivebreastfeeding, timely initiation of complementary feeding and for seekingprompt care for illness. The women in control group will continue to availroutine standard care as per National Programs.

An independent outcome ascertainment team will visit to documentoutcomes in the pre- and peri-conception period, pregnancy, postnatal and earlychildhood period

The Data Safety Monitoring Board (DSMB) will review all sample sizeassumptions when 50% of babies expected to be included in the study have beenborn and make recommendations on sample size.

The Data Safety Monitoring Board will do a second review when 50% ofbabies expected to be included in the study have reached 2 years of age.

 We propose to disseminate and publish the outcomes on disease burden andprevalence of different behaviours prior to completion of the study as thesewill be of immense value to national program planners. These include:

-Prevalence of non-communicable diseases (diabetes, pre-diabetes,hypothyroidism, hypertension, depression)

• Prevalence of anemia, micronutrient deficiency, malnutrition

• Prevalence of reproductive tract infection, tuberculosis

• Family planning practices

• Practices pertaining to WASH (including menstrual hygiene, hand and personalhygiene)

- Prevalence of substance use (including use of tobaccoand alcohol)

The factorial design allows us to assess the efficacy of pre pregnancyinterventions independently.These findings will be reported when birth outcomedata are available.