A study on effect of Integrated Nutrition, Health, WASH, Care and Support Interventions during the Pre-pregnancy, Pregnancy and Early Childhood on linear growth of children

Primary Investigator

  • Nita Bhandari

Study Period

January 2017 - January 2023

Study Description

The study will be conducted in urban neighbourhoods in South Delhi. Prior to selection of the population, a survey was conducted to ascertain stunting 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 and followed 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 her and her infant’s participation in the trial.

Once enrolled, the intervention group women will be visited by different teams. Women diagnosed with medical conditions that affect growth of the fetus and young children will be referred to Safdarjung Hospital for management. Women diagnosed with anemia or undernutrition will be treated according to the government guidelines. They will also be counselled on personal and menstrual hygiene and assisted to deal with stressful conditions through a positive frame of mind. The women in control group will continue to avail routine standard care as per National Programs.

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

During pregnancy, women in the intervention group will be encouraged for regular antenatal follow up in Safdarjung Hospital and counselled about benefits of diets consisting of adequate energy, protein, vitamins and minerals obtained from a variety of locally available foods. To account for the additional requirement of energy during pregnancy, food supplements would also be provided. In the postnatal period and early childhood, women will be encouraged to go for postnatal visits. Women will be counselled for exclusive breastfeeding, timely initiation of complementary feeding and for seeking prompt care for illness. The women in control group will continue to avail routine standard care as per National Programs.

An independent outcome ascertainment team will visit to document outcomes in the pre- and peri-conception period, pregnancy, postnatal and early childhood period

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

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

 

We propose to disseminate and publish the outcomes on disease burden and prevalence of different behaviours prior to completion of the study as these will 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 personal hygiene)

- Prevalence of substance use (including use of tobacco and alcohol)

The factorial design allows us to assess the efficacy of pre pregnancy interventions independently.These findings will be reported when birth outcome data are available. 

 

Study Arms

  • Intervention: EARLY CHILDHOOD - Health: Essential Newborn Care
  • Intervention: EARLY CHILDHOOD - Nutrition: Breastfeeding counselling
  • Intervention: EARLY CHILDHOOD - Psychosocial: Early child play and stimulation.
  • Intervention: EARLY CHILDHOOD - WASH
  • Comparator Agent: EARLY CHILDHOOD: Standard Care
  • Intervention: POSTNATAL - Mothers (Nutrition): Postnatal care
  • Intervention: POSTNATAL - Mothers (Psychosocial support): Promotion of positive thinking and problem-solving skills
  • Intervention: POSTNATAL - Mothers (WASH): Continuation of Pregnancy WASH intervention
  • Intervention: POSTNATAL- Mothers (Health)
  • Comparator Agent: POSTNATAL: Standard Care
  • Intervention: PRE AND PERICONCEPTION - Health: Birth spacing
  • Intervention: PRE AND PERICONCEPTION - Health: Detect and facilitate treatment of medical conditions known to affect growth of the fetus and young children
  • Intervention: PRE AND PERICONCEPTION - Nutrition: Adequate micronutrient intake (provide and counsel)
  • Intervention: PRE AND PERICONCEPTION - Nutrition: Detect and manage under nutrition
  • Intervention: PRE AND PERICONCEPTION - Psychosocial support: Promotion of positive thinking and problem-solving skills
  • Intervention: PRE AND PERICONCEPTION - WASH: Promotion of personal and menstrual hygiene
  • Comparator Agent: PRE AND PERICONCEPTION: Standard Care
  • Intervention: PREGNANCY - Health: Antenatal care
  • Intervention: PREGNANCY - Nutrition: Provision of a protein energy supplement
  • Intervention: PREGNANCY - Psychosocial support : Promotion of positive thinking and problem-solving skills
  • Intervention: PREGNANCY - WASH: Improvement of drinking water quality. Reduce fecal transmission via hand and reduce fecal load in living environment
  • Comparator Agent: PREGNANCY: Standard Care

Primary Outcomes

  • Linear growth by 24 months of age - length for age Z-score, proportion stunted
  • Birth weight, length
  • Proportion low birth weight
  • Proportion preterm birth
  • Proportion small-for gestation age

Study Interventions

  • Water, sanitation, hygiene (WASH)
  • Other
  • Behavior change communication (BCC)

Research Gaps

  • Effectiveness

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented "on the ground"?

  • Innovation

    What novel food-based products and programming methods effectively prevent and treat undernutrition?

Study Population

12,500