| CTRI Number |
CTRI/2025/08/093339 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Effect of an integrated package of nutrition, health, responsive care, and early child stimulation interventions from 2 to 5 years of age on linear growth, cognitive development, and metabolic health in preterm or small-for-gestational-age children, compared with routine care, in Delhi, India |
|
Scientific Title of Study
|
Impact of Integrated Interventions in the Next 1000 days to Promote Optimum Growth, Neurodevelopment and Metabolic Health in Small and Vulnerable Children (SAMPOORNA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunita Taneja |
| Designation |
Senior Scientist and Executive Director |
| Affiliation |
Society for Applied Studies |
| Address |
45 Kalusarai
New Delhi
South
DELHI
110016
India |
| Phone |
01146043751 |
| Fax |
|
| Email |
sunita.taneja@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranadip Chowdhury |
| Designation |
Senior Scientist and Deputy Director |
| Affiliation |
Society for Applied Studies |
| Address |
45 Kalusarai
New Delhi
South
DELHI
110016
India |
| Phone |
7838870359 |
| Fax |
|
| Email |
ranadip.chowdhury@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Prakash Upadhyay |
| Designation |
Senior Scientist and Deputy Director |
| Affiliation |
Society for Applied Studies |
| Address |
45 Kalusarai
New Delhi
South
DELHI
110016
India |
| Phone |
09911645513 |
| Fax |
|
| Email |
ravi.upadhyay@sas.org.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Sunita Taneja |
| Address |
Society for Applied Studies
45 Kalu Sarai
New Delhi 110016 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sunita Taneja |
Society for Applied Studies |
680, Gali No-5, Nai Basti, Devli Village, Khanpur, New Delhi-110062
South
DELHI |
01146043751-55
01146043756
sunita.taneja@sas.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Society for Applied Studies Ethics Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children born Preterm or small for gestational age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
The control group will receive routine care as per national program |
| Intervention |
Health |
Child care centre visits
Mother–child escorted every 6 months to Childcare centres.
Growth monitoring: Anthropometry (weight, height), referral; WHO guidelines.
Anemia screening and management- Annually and referral; based on Anemia Mukt Bharat (2.0).
Immunization and deworming as per National Immunization Schedule; deworming every 6 months per GOI guidelines.
Dental caries screening every 6 months.
Vision and hearing screening at 24 months; referral if indicated. |
| Intervention |
Neurodevelopment – Maternal |
Maternal mental health screening
Counselling on maternal psychosocial support - identify stressors, convert negative thoughts into positive ones, Promote problem-solving; every 2 months (24 to 36 months), every 3 months (37 to 60 months)
PHQ-9 depression screening (6 monthly); referral and follow-up if indicated. |
| Intervention |
Nutrition |
- Counselling on optimal diet Dietary diversity, portion size, responsive feeding; based on ICMR 2024, WHO guidelines.
- Micronutrient supplementation Iron–Folic Acid (IFA): Weekly dosing for 2–5 years Vitamin A: Every 6 months after 12 months of age Zinc: Therapeutic dosing during diarrheal episodes Multiple Micronutrient (Hovite L) 2.5 ml per day.
- Supplementary Nutritional Product: Food supplements to cover dietary gap of 250 to 300 Kcal/day [as per ICMR Guidelines (2024)]. |
| Intervention |
Responsive caregiving and early stimulation counselling |
Positive parenting, play-based learning, screen time reduction; WHO, AAP.
Frequency: (Monthly (24–30 months), every 2 months (32, 34, 36 months), every 3 months (39, 42, 45, 48, 51, 54, 57, 60 months)
ASQ-III screening: 6 monthly using ASQ-III; referral if delays detected. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Participant in either intervention or control group of the Small Babies Trial
Child aged 24 months (±29 days) at enrollment
Family intends to remain in study area for next 3 years
Written informed consent from parent/caregiver
|
|
| ExclusionCriteria |
| Details |
Any chronic diagnosed condition which impairs growth
Diagnosed and documented neurodevelopmental impairment currently receiving
specialized therapy
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Linear Growth: Height-for-age z-score (HAZ)
Neurodevelopment: IQ, Executive function, School readiness assessed using standardized tools |
5 years
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Metabolic Health: Biomarkers (HOMA-IR, lipid profile, HbA1c, CRP, IL-6, adiponectin, leptin. Haemoglobin |
5 years |
| Anthropometry (Wt, ht; head, waist – circumference, MUAC) |
Every 6 months starting from 2 years |
| Morbidity & care-seeking |
Every 6 months starting from 2 years |
| Dietary intake/diversity (subsample) |
Baseline, 3, 4 & 5 years |
| Parental Empowerment |
Baseline and 5 years |
| Body Composition (DXA) |
5 years |
| Non-alcoholic fatty liver disease: Abdominal ultrasound |
5 years |
| Physical activity |
Baseline, 5 years |
|
|
Target Sample Size
|
Total Sample Size="1600"
Sample Size from India="1600"
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)
|
02/09/2025 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sunita.taneja@sas.org.in].
- For how long will this data be available start date provided 01-08-2031 and end date provided 31-07-2032?
Response (Others) - 12 months
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Small
and vulnerable newborns (SVNs) represent a significant public health concern,
particularly in South Asia, which accounts for 63% of global term SGA births
and has a preterm birth prevalence of 13.2%. These infants are at increased
risk for stunted growth, cognitive delays, and metabolic disorders. Although
interventions during the first 24 months of life have demonstrated some
benefits, there is a notable lack of sustained improvements in growth,
neurodevelopment, and metabolic health as SVNs transition into early childhood.
This gap underscores the urgent need for research and innovation targeting the
next 1,000 days (ages 2 to 5 years), a critical but underexplored period for
long-term child health.
Hence
a randomized controlled factorial trial is designed to evaluate the impact of
an integrated package of interventions including optimized nutrition,
developmental stimulation, and maternal support delivered from age 2 to 5 years
to children born preterm or term SGA. Eligible children from an established
cohort will be re-randomized at 24 months and followed through 5 years of age,
with outcomes assessed for growth (height-for-age z-score), cognitive
development, and metabolic health. The trial aims to generate high-quality
evidence on scalable, multi-domain interventions to improve growth,
neurodevelopment, and metabolic outcomes in SVNs. Results will inform future
child health policies and programs and address a critical knowledge gap in the
care of this high-risk group. |