Trial results for a study investigating calibrated formula feeding to optimize infant growth for mothers with a pre-pregnancy body mass index of 25 or more were posted on ClinicalTrials.gov on 2025-05-21, with 60 participants enrolled.
Background
Obesity, particularly when present in mothers pre-pregnancy, can influence infant growth patterns and increase the risk of early childhood overweight. Promoting optimal infant growth during the first six months after birth is a critical public health goal, as early growth trajectories can have long-term implications for health and weight status. Interventions that aim to guide infant feeding practices, such as calibrated formula feeding recommendations, are explored as potential strategies to support healthy growth and potentially mitigate the risk of overweight in infants born to mothers with higher pre-pregnancy BMI.
Trial design
This completed study, designated as Phase NA, enrolled 60 participants to investigate conditions related to Overweight and Obesity. The trial aimed to determine if calibrated formula feeding recommendations could promote optimal growth for the first 6 months after birth for infants of mothers with a pre-pregnancy body mass index of 25 or more. The study compared an intervention group receiving calibrated formula feeding recommendations against a control group.
Key results
The trial reported several key measurements related to infant growth:
- Conditional Weight Gain Difference Between Study Groups:
- In the Intervention group, the mean conditional weight gain score was 0.27.
- In the Control group, the mean conditional weight gain score was -0.12.
- Another measurement for the Intervention group showed a mean conditional weight gain score of 0.28.
- For the Control group, another measurement showed a mean conditional weight gain score of -0.14.
- Mean Weight-for-Length Z-score (WLZ) on World Health Organization Child Growth Standards:
- The Intervention group had a mean WLZ of 0.73 Z-score.
- The Control group had a mean WLZ of 0.65 Z-score.
- Growth Trajectory (Repeated Measures of Weight-for-length on World Health Organization Child Growth Standards) During the Intervention Period:
- The Intervention group showed a mean growth trajectory of 12.4 kg/m.
- The Control group showed a mean growth trajectory of 12.1 kg/m.
- Percentage of Infants With Overweight (Weight-for-Length ≥95th Percentile on World Health Organization Child Growth Standards):
- 4 participants in the Intervention group were classified as overweight.
- 2 participants in the Control group were classified as overweight.
What this means
The posted results indicate that calibrated formula feeding recommendations influenced infant growth patterns in the intervention group. Infants in the intervention group showed higher mean conditional weight gain scores and higher mean weight-for-length Z-scores compared to the control group. While the intervention aimed to promote optimal growth, the data also shows a higher count of infants classified as overweight in the intervention group (4 participants) compared to the control group (2 participants). These findings provide specific growth metrics for further evaluation of feeding strategies in this population, though no statistical analyses or significance values are provided in the current data.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05104073, titled "Califormula Study: Calibrated Formula Feeding to Optimize Infant Growth", were posted on 2025-05-21 on clinicaltrials.gov.