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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/06/008908
• Date of registration: 23-06-2017
• Prospective Registration: Yes
• Primary sponsor: Nita Bhandari
• Public title: 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
• Scientific title: 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 - Women and Infants Integrated Growth Study (WINGS)
• Date of first enrolment: 01-07-2017
• Target sample size: 13500
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339
• Study type: Interventional
• Study design: Randomized Factorial Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Nita Bhandari
• Affiliation: Centre for Health Research and Development, Society for Applied Studies

• Name: Nita Bhandari
• Affiliation: Centre for Health Research and Development, Society for Applied Studies

Key inclusion & exclusion criteria

Inclusion criteria: Married and living with their husband with no child or 1 child and wish to have more children

Consent to participate
Exclusion criteria: Moving away

Population likely to relocate



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: PRE AND PERICONCEPTION - Health: Detect and facilitate treatment of medical conditions known to affect growth of the fetus and young children: As per hospital policy
Screen and treat medical conditions known to affect fetal and infant growth, bi-annual deworming
Intervention2: PRE AND PERICONCEPTION - Health: Birth spacing: Family planning counselling and provision of contraceptives
Intervention3: PRE AND PERICONCEPTION - Nutrition: Adequate micronutrient intake (provide and counsel): Iron folic acid and, multiple micronutrients supplementation
Intervention4: PRE AND PERICONCEPTION - Nutrition: Detect and manage under nutrition: High quality protein and
energy dense snacks
Screen and manage malnutrition and anemia, egg or milk to women with BMI 21 kg/m2

Intervention5: PRE AND PERICONCEPTION - WASH: Promotion of personal and menstrual hygiene: Counselling
Intervention6: PRE AND PERICONCEPTION - Psychosocial support: Promotion of positive thinking and problem-solving skills: Counselling
Promote positive thinking and problem-solving skills, screen and manage depressive symptoms, substance abuse and exposure to second hand smoke
Intervention7: PREGNANCY - Health: Antenatal care: As per WHO recommendations
Minimum 8 antenatal contacts, Screen and treat medical conditions, Tetanus Toxoid immunization, deworming
Intervention8: PREGNANCY - Nutrition: Provision of a protein energy supplement: Provision of High quality protein and energy dense snacks,
Iron folic acid and multiple micronutrients supplementation (Calcium and vitamin D), Weight monitoring and management for low weight gain


Intervention9: PREGNANCY - WASH: Improvement of drinking water quality. Reduce fecal transmission via hand and reduce fecal load in living environment: Provision of water fil

Primary Outcome(s)

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 ageTimepoint: Linear growth by 24 months of age - length for age Z-score, proportion stunted



Birth (within 1 week)



Birth (within 1 week)



Birth (within 1 week)



Birth (within 1 week)

Secondary Outcome(s)

INTERMEDIATE OUTCOMES: Micronutrient status, anemia status and inflammatory markersTimepoint: 24 months

POSTPARTUM OUTCOMES - Anemia statusTimepoint: 6 months

CHILDREN GROWTH AND DEVELOPMENT: Neurodevelopment scoreTimepoint: 24 months

DISEASE BURDEN OUTCOMES (WOMEN AND CHILDREN): Prevalence of non-communicable diseases, anemia, micronutrient deficiency, malnutrition and infectious diseasesTimepoint: Throughout the study period

BEHAVIOUR OUTCOMES(WOMEN AND CHILDREN): Family planning, substance abuse, WASH behavioursTimepoint: Throughout the study period

CHILDREN GROWTH: Body composition in a subgroupTimepoint: At 1 month

POSTPARTUM OUTCOMES - Severe postpartum morbidityTimepoint: Day 7 of birth

INTERMEDIATE OUTCOMES: Mother infant bonding in a subgroupTimepoint: 6,12 and 18 months

WOMEN: Pregnancy outcomesTimepoint: At end of pregnancy

CHILD GROWTH: Weight and length growth trajectoriesTimepoint: Between birth and 24 mo

CHILDREN GROWTH AND DEVELOPMENT: Caregiver reported developmental outcomesTimepoint: 12 and 24 months

INTERMEDIATE OUTCOMES: Breastfeeding initiation within 1 hour of birthTimepoint: Up to day 7 of birth

INTERMEDIATE OUTCOMES: Exclusively breastfedTimepoint: 1 and 6 months

WOMEN: Anaemia status; Micronutrient status; inflammatory markers; Reproductive tract infectionsTimepoint: Third trimester

WOMEN: BMI of woman; Anaemia status; Micronutrient status; Inflammatory markers; thyroid and diabetes status;

Depression; Reproductive tract infectionsTimepoint: At the time of reporting pregnancy

INTERMEDIATE OUTCOMES: Severe infection in the neonatal period; Prevalence of diarrhea, dysentery, pneumonia, fever in the previous 2 weeks; Prevalence of persistent diarrhea in the previous 4 weeks; Any chronic morbidityTimepoint: 1, 6, 12, 18 and 24 months

POSTPARTUM OUTCOMES: BMITimepoint: 6 and 12 months postpartum

WOMEN: Weight gain during second and third trimesterTimepoint: Second and third trimester

POSTPARTUM OUTCOMES - Inflammatory markersTimepoint: 6 months

CHILDREN GROWTH AND DEVELOPMENT: Body size - Mean length for age Z-score, proportion stunted, mean weight for length Z-score, mean weight for age Z-score, proportion wasted and underweight, mid-upper arm circumference

Timepoint: 6,12, 24 months

INTERMEDIATE OUTCOMES: Complementary feedingTimepoint: 9, 12, 18, 24 months

POSTPARTUM OUTCOMES - Micronutrient statusTimepoint: 6 months

POSTPARTUM OUTCOMES - Postpartum depressionTimepoint: 2 and 12 months

WOMEN: Birth outcomes, stillbirthsTimepoint: End of pregnancy

CHILDREN GROWTH AND DEVELOPMENT: Head circumferenceTimepoint: Day 7, 12, 24 months

INTERMEDIATE OUTCOMES: Continued breastfeedingTimepoint: 12, 18, 24 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Biotechnology Industry Research Assistance Council (BIRAC) of the Department of Biotechnology, Government of India, 1st Floor ,MTNL Building ,9 , CGO Complex, Lodhi Road, New Delhi-110003 (Next to Scope Complex, Infront of Gate no. 13, JLN Stadium)

Bill & Melinda Gates Foundation, Seattle, USA (supplementary funds approved in September 2018)

Ethics review

Status: Approved
Approval date: 03/06/2017
Contact:

Society for Applied Studies Ethics Review Committee

Status: Approved
Approval date: 10/01/2019
Contact:

Society for Applied Studies Ethics Review Committee

Status: Approved
Approval date: 22/07/2019
Contact:

Society for Applied Studies Ethics Review Committee