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Table 3 Association between nutritional interventions and depression a

From: Mediterranean dietary pattern and depression: the PREDIMED randomized trial

Analysis

Total, n

Cases, n

Nutritional intervention, HR (95% CI)

   

Control diet

MD-EVOO

MD-nuts

Excluding late cases (>6 years of follow-up)

3,893

211

1 (ref)

0.88 (0.64 to 1.21)

0.73 (0.52 to 1.05)

Including only participants with diabetes

1,958

113

1 (ref)

0.71 (0.46 to 1.09)

0.59 (0.36 to 0.98)

Including only participants with hypertension

3,181

181

1 (ref)

0.93 (0.66 to 1.31)

0.79 (0.54 to 1.16)

Including only participants with hypercholesterolemia

2,697

158

1 (ref)

0.93 (0.64 to 1.35)

0.81 (0.54 to 1.21)

Including only participants with obesity

1,781

113

1 (ref)

0.85 (0.55 to 1.31)

0.69 (0.41 to 1.13)

Excluding participants with limiting conditionsb

3,074

184

1 (ref)

0.81 (0.57 to 1.13)

0.68 (0.46 to 0.99)

Excluding participants with cancer

3,824

216

1 (ref)

0.90 (0.66 to 1.24)

0.79 (0.56 to 1.12)

Excluding participants with potentially missing eventsc

3,867

224

1 (ref)

0.91 (0.66 to 1.24)

0.78 (0.55 to 1.10)

Multiple imputation for missing values

82,383

4,740

1 (ref)

0.95 (0.69 to 1.32)

0.75 (0.52 to 1.07)

  1. Abbreviations: HR hazard ratio, MD Mediterranean diet, ref reference group, EVOO extra virgin olive oil.
  2. aAdjusted for age, sex, recruiting center, body mass index, smoking, physical activity during leisure time, educational level, marital status, alcohol and total energy intake, and the presence of several diseases at baseline (cancer, diabetes mellitus type 2, hypertension, hypercholesterolemia, fractures, Parkinson disease and chronic bronchitis).
  3. bSuch as fractures, PD, and chronic bronchitis.
  4. cApproaches for dealing with missing data were as follows. We implemented the suggestions given by Groenwold et al. [25] to handle potentially missing outcome data in randomized trials. In order to conduct sensitivity analyses on missing outcomes, we considered as missing outcome data the potential occurrence of depression for 59 participants for whom we had no documented incident depression and who were lost to follow-up for 2 years or longer. We conducted two sensitivity analyses: 1) in the complete case analysis we excluded these 59 subjects from the computation of HRs and adjusted the Cox model for all the covariates mentioned in Table 3; 2) in multiple imputations, 20 values were sampled from an estimated uniform distribution (also taking into account the previously mentioned predictors) and imputed for the 59 participants lost to follow-up adding a random term. Hence, 20 datasets with imputed outcomes were created. Each dataset was analyzed using multivariable-adjusted Cox models and, subsequently, the results were pooled by using standard techniques, also taking into account the variation between imputed data sets [24].
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BMC Medicine

ISSN: 1741-7015

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