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CTRI Number  CTRI/2017/06/008908 [Registered on: 23/06/2017] Trial Registered Prospectively
Last Modified On: 26/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Nutraceutical 
Study Design  Randomized Factorial Trial 
Public Title of Study
Modification(s)  		 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 of Study
Modification(s)  		 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 
Trial Acronym  Women and Infants Integrated Growth Study (WINGS) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nita Bhandari 
Designation  Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai

New Delhi
DELHI
110016
India 
Phone  01146043751  
Fax  01146043756  
Email  chrd@sas.org.in  
 
Details of Contact Person
Scientific Query  
Name  Nita Bhandari 
Designation  Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai

New Delhi
DELHI
110016
India 
Phone  01146043751  
Fax  01146043756  
Email  chrd@sas.org.in  
 
Details of Contact Person
Public Query  
Name  Nita Bhandari 
Designation  Senior Scientist 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai

New Delhi
DELHI
110016
India 
Phone  01146043751  
Fax  01146043756  
Email  chrd@sas.org.in  
 
Source of Monetary or Material Support
Modification(s)  
Bill & Melinda Gates Foundation, Seattle, USA (supplementary funds approved in September 2018) 
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) 
 
Primary Sponsor  
Name  Nita Bhandari 
Address  Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi-110016, India  
Type of Sponsor  Other [Not for profit research organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nita Bhandari  Centre for Health Research and Development, Society for Applied Studies  680, Nai Basti, Devli Gaon, Khanpur, 110062
New Delhi
DELHI 		 01146043751
01146043756
chrd@sas.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Society for Applied Studies Ethics Review Committee  Approved 
Society for Applied Studies Ethics Review Committee   Approved 
Society for Applied Studies Ethics Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Screening of medical conditions that affect growth 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  EARLY CHILDHOOD - Health: Essential Newborn Care  As per WHO recommendations Educate families to identify danger signs and early care seeking for illness, Counsel on timely immunisation  
Intervention  EARLY CHILDHOOD - Nutrition: Breastfeeding counselling; Micronutrient supplementation for low birth weight babies; Nutrition interventions as per WHO recommendations. Growth monitoring and management of moderate and severe malnutrition; Initiation of complementary feeding at 6 months; Balanced protein energy supplementation to augment complementary feeding from 6 to 24 months  As per WHO recommendations 0-6 mo: Counselling on initiation of breastfeeding within first hour of birth and exclusive breast feeding till 6 mo, lactation support, growth monitoring and management of inadequate weight gain, vitamin D supplementation, Iron supplementation for very low birth weight infants 6-24m: Counsel on timely initiation of complementary feeding, continuing breastfeeding till 24 mo, Daily provision of locally-prepared food packets with 125 kcal/2.5 g protein and 1 RDA micronutrients, Counselling on preparing home based foods and responsive feeding, iron folic acid supplementation  
Intervention  EARLY CHILDHOOD - Psychosocial: Early child play and stimulation. Strengthening mother-child bonding  Counselling demonstration and practice sessions on early child play and responsive care  
Intervention  EARLY CHILDHOOD - WASH  Provision of play mat and potty 
Comparator Agent  EARLY CHILDHOOD: Standard Care  As per National Programs 
Intervention  POSTNATAL - Mothers (Nutrition): Postnatal care  Postnatal care as per WHO recommendations Iron folic acid, Calcium, Vitamin-D and multiple micronutrients supplementation, Daily provision of locally-prepared snacks and milk supplement for 6 mo 
Intervention  POSTNATAL - Mothers (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 
Intervention  POSTNATAL - Mothers (WASH): Continuation of Pregnancy WASH intervention   Provision of water filters and bottles for drinking water, hand washing station and soap/ sanitizer, latrine disinfectant. 
Intervention  POSTNATAL- Mothers (Health)   Facilitate postnatal hospital visit at 6 weeks 
Comparator Agent  POSTNATAL: Standard Care  As per National Programs 
Intervention  PRE AND PERICONCEPTION - Health: Birth spacing  Family planning counselling and provision of contraceptives  
Intervention  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 
Intervention  PRE AND PERICONCEPTION - Nutrition: Adequate micronutrient intake (provide and counsel)  Iron folic acid and, multiple micronutrients supplementation 
Intervention  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  
Intervention  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 
Intervention  PRE AND PERICONCEPTION - WASH: Promotion of personal and menstrual hygiene  Counselling 
Comparator Agent  PRE AND PERICONCEPTION: Standard Care  As per National Programs 
Intervention  PREGNANCY - Health: Antenatal care   As per WHO recommendations Minimum 8 antenatal contacts, Screen and treat medical conditions, Tetanus Toxoid immunization, deworming  
Intervention  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  
Intervention  PREGNANCY - Psychosocial support : Promotion of positive thinking and problem-solving skills   Counseling Promote positive thinking and problem-solving skills, screen and manage depressive symptoms, substance abuse and exposure to second hand smoke 
Intervention  PREGNANCY - WASH: Improvement of drinking water quality. Reduce fecal transmission via hand and reduce fecal load in living environment   Provision of water filters and bottles for drinking water, hand washing station and soap/ sanitizer, latrine disinfectant 
Comparator Agent  PREGNANCY: Standard Care  As per National Programs 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Married and living with their husband with no child or 1 child and wish to have more children
Consent to participate 
 
ExclusionCriteria 
Details  Moving away
Population likely to relocate
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
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 		 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
Modification(s)  
Outcome  TimePoints 
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
 		 6,12, 24 months 
CHILDREN GROWTH AND DEVELOPMENT: Head circumference   Day 7, 12, 24 months 
CHILDREN GROWTH AND DEVELOPMENT: Neurodevelopment score  24 months 
CHILDREN GROWTH AND DEVELOPMENT: Caregiver reported developmental outcomes   12 and 24 months 
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 morbidity   1, 6, 12, 18 and 24 months  
INTERMEDIATE OUTCOMES: Breastfeeding initiation within 1 hour of birth  Up to day 7 of birth 
INTERMEDIATE OUTCOMES: Exclusively breastfed   1 and 6 months 
INTERMEDIATE OUTCOMES: Continued breastfeeding  12, 18, 24 months 
INTERMEDIATE OUTCOMES: Complementary feeding   9, 12, 18, 24 months 
INTERMEDIATE OUTCOMES: Micronutrient status, anemia status and inflammatory markers  24 months 
INTERMEDIATE OUTCOMES: Mother infant bonding in a subgroup  6,12 and 18 months 
WOMEN: BMI of woman; Anaemia status; Micronutrient status; Inflammatory markers; thyroid and diabetes status;
Depression; Reproductive tract infections  		 At the time of reporting pregnancy 
WOMEN: Pregnancy outcomes  At end of pregnancy 
WOMEN: Birth outcomes, stillbirths   End of pregnancy 
WOMEN: Weight gain during second and third trimester   Second and third trimester 
POSTPARTUM OUTCOMES: BMI  6 and 12 months postpartum 
DISEASE BURDEN OUTCOMES (WOMEN AND CHILDREN): Prevalence of non-communicable diseases, anemia, micronutrient deficiency, malnutrition and infectious diseases  Throughout the study period 
BEHAVIOUR OUTCOMES(WOMEN AND CHILDREN): Family planning, substance abuse, WASH behaviours  Throughout the study period 
CHILD GROWTH: Weight and length growth trajectories  Between birth and 24 mo 
CHILDREN GROWTH: Body composition in a subgroup  At 1 month 
WOMEN: Anaemia status; Micronutrient status; inflammatory markers; Reproductive tract infections   Third trimester 
POSTPARTUM OUTCOMES - Micronutrient status  6 months 
POSTPARTUM OUTCOMES - Anemia status   6 months 
POSTPARTUM OUTCOMES - Inflammatory markers  6 months 
POSTPARTUM OUTCOMES - Severe postpartum morbidity  Day 7 of birth 
POSTPARTUM OUTCOMES - Postpartum depression  2 and 12 months 
 
Target Sample Size
Modification(s)  		 Total Sample Size="13500"
Sample Size from India="13500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  		 Years="6"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 Taneja S, Chowdhury R, Dhabhai N, Mazumder S, Upadhyay RP, Sharma S, Dewan R, Mittal P, Chellani H, Bahl R, Bhan MK, Bhandari N; Women and Infants Integrated Growth Study (WINGS) Group. Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India. Trials. 2020 Jan 31;21(1):127. doi: 10.1186/s13063-020-4059-z. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

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. 

 
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