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CTRI Number  CTRI/2024/12/077916 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Health, Nutrition, and Early Stimulation Package on Body Composition of Infants Born Preterm or Small for Gestational Age  
Scientific Title of Study   Impact of an integrated health, nutrition and early child stimulation intervention package delivered to preterm and small for gestational babies during infancy, on body composition 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranadip Chowdhury 
Designation  Scientist and Assistant Director  
Affiliation  Society for Applied Studies 
Address  Society for Applied Studies Nutrition Department 45 Kalusarai New Delhi

South West
DELHI
110016
India 
Phone  01146043751  
Fax    
Email  ranadip.chowdhury@sas.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rukman Manapurath 
Designation  Scientist 
Affiliation  Society for Applied Studies 
Address  Society for Applied Studies Nutrition Department 45 Kalusarai New Delhi

South
DELHI
110016
India 
Phone  9809124809  
Fax    
Email  rukman.manapurath@sas.org.in  
 
Details of Contact Person
Public Query  
Name  Dr Rukman Manapurath 
Designation  Scientist 
Affiliation  Society for Applied Studies 
Address  Society for Applied Studies Nutrition Department 45 Kalusarai New Delhi

South
DELHI
110016
India 
Phone  9809124809  
Fax    
Email  rukman.manapurath@sas.org.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, New Delhi. Society for Applied Studies, New Delhi  
 
Primary Sponsor  
Name  Dr Ranadip Chowdhury 
Address  45 Kalusarai Society for Applied Studies New Delhi 110016  
Type of Sponsor  Other [Self] 
 
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 
Dr Ranadip Chowdhury  Society for Applied Studies  Department of Nutrition 680, Nai Basti, Devli Gaon, Khanpur, 110062
South
DELHI 		 7838870359

ranadip.chowdhury@sas.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Society for Applied Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Metabolic Abnormality of Preterm small for gestational age  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Care routinely sought from usual sources-government (free of cost) and private providers  Care routinely sought from usual sources-government (free of cost) and private providers- for infants and postpartum mothers till 12 months of age  
Intervention  Early Child play and stimulation  Counselling, demonstration, and practice sessions for mothers and other family members on early child play and responsive care Referral to a developmental pediatrician or psychologist if indicated.  
Intervention  Exclusive Breastfeeding till 6 months of age Kangaroo mother care during neonatal period Micronutrient supplementation till 6 months of age Optimal complementary feeding :6-12 months Continued Breastfeeding till 12 months Growth Monitoring   Counselling and support for exclusive breastfeeding till 6 months of age. Lactation counseling and support, including feeding of expressed breast milk if indicated (assessed by lactation counselor). Promotion of and support to mothers/ caregivers for effective Kangaroo mother care Daily vitamin D, Iron supplementation till 6 months as per WHO recommendations at 1 RDA dose. Micronutrients like vitamin A, Zinc and other B vitamins are given as multiple micronutrient supplementation based on their evidence. Counselling and support for timely initiation, and continuation of complementary feeding Demonstration of preparation of home-based foods and responsive feeding Provision of milk cereal mix (125 kcal/ 5 g protein and 1 RDA micronutrients) as a supplement to breastfeeding to infants aged 6-12 months. Counselling and support for continued breastfeeding till 12 months Growth monitoring fortnightly in the first 2 months of life and subsequently monthly. Identification and management (medical and nutritional) of growth failure based on growth velocity and attained weight and length.  
Intervention  Health and health services care seeking  Identifying danger signs and seeking appropriate and early care for illness. Appropriate management through study clinic and referral to the hospital if necessary Prevention of infectious diseases through counseling and facilitation of timely immunization Counselling and demonstration of correct handwashing practices to caregivers  
Intervention  Health interventions for postpartum mothers   Counselling on postnatal check-ups Referral to the health facility, if necessary, for any illnesses Counselling on family planning and provision of contraceptives if requested for  
Intervention  Nutrition Interventions for postpartum mothers including Macro and Micro-nutrient Supplementation  Multiple micronutrient supplementation Provision of additional requirement of energy and protein through locally prepared snacks (600 Kcal energy and 20 g protein) in the first 6 months postpartum  
Intervention  Psychosocial Support for postpartum mothers   Promote positive thinking and problem-solving skills 
 
Inclusion Criteria  
Age From  12.00 Month(s)
Age To  13.00 Month(s)
Gender  Both 
Details  1. Children participating in Small Babies Trial
2. Completed 12 months of age  
 
ExclusionCriteria 
Details  1. Non-Consent
2. Not Available at the time of assessment  
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean Attained Lean mass  12 months of age  
 
Secondary Outcome  
Outcome  TimePoints 
Bone mineral density (g/cm²)  12 months of age 
Regional fat distribution  12 months of age  
Differential effect on body composition in preterm SGA, term SGA, and preterm AGA infants  12 months of age  
Fat mass (g)  12 months of age  
 
Target Sample Size   Total Sample Size="1048"
Sample Size from India="1048" 
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)   10/01/2025 
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   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ranadip.chowdhury@sas.org.in].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2027?
    Response (Others) -  12 months

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Preterm and small for gestational age (SGA) infants represent a significant public health concern, particularly in South Asia, where they account for nearly 41% of live births. These infants face dual risks of excess fat gain and poor skeletal development, increasing their susceptibility to adult non-communicable diseases (NCDs) through metabolic programming. Current evidence suggests these risks stem from suboptimal growth trajectories and early-life nutritional deficiencies. While interventions targeting body composition have shown some promise, evidence on comprehensive approaches is sparse, particularly in low- and middle-income settings.

This study, embedded in an ongoing RCT (pubmed.ncbi.nlm.nih.gov/38331842/), seeks to assess the impact of integrated health, nutrition, and early child stimulation interventions on body composition at 12 months of age. Interventions include breastfeeding support, growth monitoring, nutritional supplementation with a milk cereal mix, and early child stimulation activities. Using a fan-beam Dual-energy X-ray Absorptiometry (DXA) with infant-adapted Lunar software, it will measure lean mass, fat mass, and bone mineral density (BMD). The findings aim to optimize growth interventions for preterm and SGA infants, informing policies to mitigate the dual burden of malnutrition and NCD risk in vulnerable populations. 

 
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