Impact of an integrated intervention package during preconception, pregnancy, and early childhood on inflammation, IGF-1, IGFBP3 during the first 6 months of life: Findings from the WINGS randomized controlled trial

Data files

Dec 02, 2025 version files 61.15 KB

dataset_inflammatorymarkermanuscript_28.11.25.xlsx

56.10 KB
README.md

5.04 KB

Abstract

Early-life interventions targeting maternal and child health, nutrition, and psychosocial care may influence infant growth and immune development by modulating systemic inflammation and growth factor pathways. However, causal evidence of comprehensive, integrated interventions initiated during early life is limited. The study was nested in a factorial randomized controlled trial (RCT) in women aged 18–30 years. Participants included in this study were randomized to receive either a preconception intervention package or routine care until early childhood. The intervention included health care for growth-related conditions, nutrition, WASH (water, sanitation, and hygiene), and psychosocial care. The primary study demonstrated a substantial effect of the intervention on growth and development. Blood samples from 381 (178 from the intervention group and 203 from the control group) infants were analyzed at 3 and 6 months of age for inflammatory and growth-related biomarkers: C-reactive protein (CRP), alpha-1-acid glycoprotein (AGP), insulin-like growth factor 1 (IGF-1), and IGF binding protein 3 (IGFBP3). Generalized linear models were used to estimate the mean differences and relative risks of inflammatory markers and growth-related biomarkers between the intervention and routine care groups. Baseline maternal characteristics were similar between the two study groups. At 3 and 6 months, the proportion of infants with CRP levels greater than 5 mg/L was similar in both groups. No significant differences were observed in AGP or IGF-1 concentrations at either time point. IGFBP3 was lower in the intervention group at 3 months (adjusted mean difference: –30.8 ng/mL; 95% CI: –55.3, –6.3), but this effect was not sustained at 6 months. An integrated intervention delivered from preconception through pregnancy and early childhood did not result in reductions in markers of systemic inflammation or sustained improvements in growth factor profiles during the first six months of life. These findings highlight the complexity of early-life inflammatory processes and underscore the need for further research on the long-term and synergistic effects of early interventions in low-resource settings.

Dataset DOI: 10.5061/dryad.6t1g1jxbs

Description of the data and file structure

File: dataset_inflammatorymarkermanuscript_28.11.25.xlsx

Integrated Intervention Effects on Infant Inflammation and IGF Axis

The dataset originated from a randomized controlled trial. The study involved recruitment, interventions, and follow-up assessments. Blood samples were collected by the research team. All outcome assessments were conducted by a separate team that was not involved in the intervention delivery and was blinded to group assignments before the measurement process. Ethical clearance for this study was granted by the Ethics Review Committee of the Society for Applied Studies, New Delhi, India. This study was registered with the Clinical Trial Registry of India.

Files and variables

File: dataset_inflammatorymarkermanuscript_05.10.25.xlsx

Description:

Variables

group_ad	0 = Control
	1 = Intervention

woman_age	continuous variable

woman_height	continuous variable

bmi_cat_markerstudy	1 = less than 18.5
	2 = 18.5 to 24.99
	3 = more than equal to 25

fam_typ_markerstudy	1 = nuclear family
	4 = Joint/ Extended family

school_cat	1 = >=12 years
	2 = <12 years

homemaker	1 = homemaker
	0 = not- homemaker

bplcard1	1 = do not possess bpl card
	2 = possess bpl card

insurance	1 = Family covered by health insurance scheme

birth_place	1 = Middle level hospital/ small hospital/ birthing centre
	2 = Large hospital
	3 = Home

crp_3m_cat	1 = > 5 mg/L
	0 = <= 5 mg/L

crp_6m_cat	1 = > 5 mg/L
	0 = <= 5 mg/L

agp_3m_cat	1 = > 1 g/L
	0 = <= 1 g/L

agp_6m_cat	1 = > 1 g/L
	0 = <= 1 g/L

crpmgl_3m_upd	CRP at 3 months (mg/L)

crpmgl_6m_upd	CRP at 6 months (mg/L)

agpgl_3m_upd	AGP at 3 months (g/L)

agpgl_6m_upd	AGP at 6 months (g/L)

igf1ngml_3m_upd	IGF-1 at 3 months (ng/mL)

igf1ngml_6m_upd	IGF-1 at 6 months (ng/mL)

igfbp3ngml_3m	IGFBP3 at 3 months (ng/mL)

igfbp3ngml_6m	IGFBP3 at 6 months (ng/mL)
n/a	not available

Code/software

Google sheet

OR
2. Microsoft Excel 2007 or later

Access information

Other publicly accessible locations of the data:

None

Data was derived from the following sources:

Community-based randomised controlled study.

Human subjects data

I confirm that I received informed consent from the participants to publish the de-identified data in the public domain, and I have removed all the personal identifiers from the data.