Correction: Effects of Mediterranean diet during pregnancy on the onset of overweight or obesity in the offspring: a randomized trial

Correction to: International Journal of Obesity https://doi.org/10.1038/s41366-024-01626-z, published online 18 September 2024

In the original version of the manuscript, we reported the results of the primary study outcome providing data on per-protocol analysis (PPA) and intention-to-treat analysis (ITT), assuming a best-case scenario (i.e., with MD children lost to follow-up (n = 5) assigned a positive outcome and with CT children lost to follow-up (n = 2) assigned a negative outcome), and a worst-case scenario (i.e., with MD children lost to follow-up (n = 5) assigned a negative outcome and with CT children lost to follow-up (n = 2) assigned a positive outcome). Subsequently, due to the length of the manuscript, Table 2 was revised with the aim of presenting only the worst-case scenario data of the ITT analysis. Unfortunately, due to a cut-and-paste error, in the manuscript as well as in Table 2 we stated that data were referring to worst-case scenario, whereas the data provided in the text referred to best-case scenario.

Please be assured that this error does not affect the overall findings of the study. As confirmed by the PPA reporting that the absolute risk difference in overweight or obesity was −24% (95% CI −38% to −9%) for the MD arm in comparison to the CT arm, resulting in an NNT of 4 (95% CI 2 to 12), we feel that our conclusions remain valid: Mediterranean Diet has proven to be an effective strategy in preventing obesity in the offspring of women who completed the follow-up.

In the abstract, the following sentence “At 24 months, children of MD mothers were less likely to have overweight or obesity than those of the CT mothers (6% vs. 33%, absolute risk difference = −27%, 95% CI −41% to −12%, p < 0.001; number needed to treat 3, 95% CI 2 to 8, intention to treat analysis)” was corrected to: “At 24 months, children of MD mothers were less likely to have overweight or obesity than those of the CT mothers (6% vs. 30%, absolute risk difference = −24%, 95% CI −38% to −9%, p = 0.003, number needed to treat 4, 95% CI 2 to 12, per-protocol analysis).”

The sentence “The mean (SD) methylation rate of the leptin gene in cord blood was 30.4 (1.02) % and 16.9 (2.99) % in the CT and MD mothers, respectively (p < 0.0001)”, included in the abstract and the ‘Results’ section of the article, was corrected as follows: “The mean (SD) methylation rate of the leptin gene in cord blood was 30.4 (1.02) % and 16.9 (2.99) % in the MD and CD mothers, respectively (p < 0.0001).”

In the ‘Results’ section of the article, the following paragraph was corrected: “At ITT assuming a worst-case scenario, i.e., with MD children lost to follow-up (n = 5) assigned a negative outcome and with CT children lost to follow-up (n = 2) assigned a positive outcome, the absolute risk difference for MD vs. CT was −0.27 (95% CI −0.41 to −0.12), corresponding to an NNT of 3 (95% CI 2 to 8). At PPA, no child (0%) of the mothers enrolled in the MD arm had obesity as compared to 4 (8%) of those born from mothers in the CT group, with corresponding figures of 3 (6%) vs. 11 (22%) for overweight”. The correct version reads as follows: “At ITT, the absolute risk difference was maintained under the best-case scenario, with MD children lost to follow-up (n = 5) assigned a positive outcome and with CT children lost to follow-up (n = 2) assigned a negative outcome (−27%, 95% CI −41% to −13%), but under the worst-case scenario, i.e., with MD children lost to follow-up (n = 5) assigned a negative outcome and with CT children lost to follow-up (n = 2) assigned a positive outcome, declined below the frequency of 20% that we could detect with the available sample size, even if the sign of the absolute risk difference was preserved (−14%) and its 95%CI (−29% to 2%) were still compatible with a mostly positive effect of reduction of overweight and obesity.”

Additionally, Table 2 was updated accordingly.

Table 2 in the original article:

Table 2 Incidence of overweight or obesity at 24 months in the offspring.

 

Per-protocol analysis

Intention to treat analysis-worst-case scenario*

MD event rate

n/N

3/47

3/(47 + 5)

Proportion (95%CI)

0.06 (0.13 to 0.17†)

0.06 (0.01 to 0.16†)

CT event rate (n/N)

n/N

15/50

(15 + 2)/52

Proportion (95%CI)

0.30 (0.18 to 0.45†)

0.33 (0.20 to 0.47†)

Absolute risk difference

(MD-CT)

−0.24 (−0.38 to −0.09††)

p = 0.003†††

−0.27 (−0.41 to −0.12††)

p < 0.001†††

Number needed to treat

4 (2 to 12)

3 (2 to 8)

*Positive outcome assigned to children missed at follow-up in the CT arm (n = 2) and negative outcome assigned to those missed at follow-up in the MD arm (n = 5). † Exact (Clopper-Pearson) 95%CI. †† 95%CI calculated using binomial regression. ††† p-value obtained from Pearson’s Chi-square as per study design. †††† Confidence intervals from Bender’s formula. MD Mediterranean Diet arm, CT control arm.

Table 2 – Incidence of overweight or obesity at 24 months in the offspring.

 

Per-protocol analysis

Intention to treat analysis-best-case scenario*

Intention to treat analysis-worst-case scenario**

MD event rate

n/N

3/47

3/52

8/52

Proportion (95% CI)

0.06 (0.01 to 0.17†)

0.06 (0.01 to 0.16†)

0.15 (0.07 to 0.28†)

CT event rate

n/N

15/50

17/52

15/52

Proportion (95% CI)

0.30 (0.18 to 0.45†)

0.33 (0.20 to 0.47†)

0.29 (0.17 to 0.43†)

Absolute risk difference

(MD-CT)

−0.24 (−0.38 to −0.09††)

p = 0.003†††

−0.27 (−0.41 to −0.13††)

p < 0.001†††

−0.14 (−0.29 to 0.02††)

0.098†††

Number needed to treat††††

4 (2 to 12)

3 (2 to 8)

NA

*Positive outcome assigned to children missed at follow-up in the MD arm and negative outcome assigned to those missed at follow-up in the CT arm. **Negative outcome assigned to children missed at follow-up in the MD arm and positive outcome assigned to those missed at follow-up in the CT arm. †Exact (Clopper-Pearson) 95% CI. ††95% CI calculated using binomial regression. †††p value obtained from Pearson’s Chi-square as per study design.

The original article has been corrected.

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