Table 2.
Mean (±standard error) estimates derived from mixed model repeated measures (MMRM, unadjusted estimates) comparing differences between the dietary support (DS) and social support (SS) groups in terms of changes from baseline to primary endpoint of 12 weeks
| Characteristic | DS | SS | Between-group differences in change from baseline to 12 weeks | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 12 weeks | Baseline | 12 weeks | ||||||
| M (SE) | M (SE) | M (SE) | M (SE) | M (SE) | 95% CI [LCI, UCI] | t a | df | p | |
| Symptoms | |||||||||
| MADRS (0-60) | 26.1 (1.0) | 14.8 (1.1) | 24.7 (1.0) | 20.5 (1.2) | 7.1 (1.6) | 3.9, 10.4 | 4.38 | 60.7 | <.001 |
| HADS – (D) (0-21) | 10.0 (0.6) | 5.3 (0.7) | 9.2 (0.6) | 6.8 (0.7) | 2.3 (1.1) | 0.2, 4.4 | 2.20 | 55.1 | .032 |
| HADS – (A) (0-21) | 12.1 (0.6) | 8.4 (0.6) | 11.2 (0.6) | 9.5 (0.7) | 2.0 (0.9) | 0.2, 3.9 | 2.19 | 59.0 | .033 |
| Mood | |||||||||
| POMS (-32–200) | 54.5 (6.0) | 30.3 (6.5) | 40.9 (5.8) | 32.1 (6.7) | 15.4 (9.9) | -4.6, 35.3 | 1.56 | 43.5 | .127 |
| Self-efficacy | |||||||||
| GSE (10-40) | 24.6 (1.0) | 28.1 (1.0) | 25.7 (1.0) | 26.7 (1.1) | -2.4 (1.6) | -5.7, 0.9 | -1.44 | 59.0 | .156 |
| Wellbeing | |||||||||
| WHO-5 (0-25) | 6.9 (0.8) | 12.3 (0.9) | 6.7 (0.8) | 10.3 (1.0) | -1.8 (1.7) | -5.2, 1.6 | -1.04 | 62.0 | .304 |
| Anthropometry | |||||||||
| BMI | 30.0 (1.4) | 29.9 (1.4) | 29.0 (1.4) | 29.1 (1.4) | 0.15 (0.27) | -0.4, 0.7 | 0.56 | 47.0 | .579 |
| Physical activity (IPAQ scores) | 2307.7 (664.8) | 2251.3 (645.9) | 2509.4 (636.3) | 2892.2 (636.3) | 439.3 (1097.6) | -1757.2, 2635 | 0.40 | 58.9 | .690 |
| Diet | |||||||||
| ModiMedDiet (0-120) | 36.2 (2.5) | 55.1 (2.8) | 47.3 (2.6) | 45.4 (2.9) | -20.7 (4.3) | -20.7, -12.1 | -4.78 | 55.62 | <.001 |
| Biomarkers | |||||||||
| Glucose (mmol/L) | 4.5 (0.5) | 4.7 (5.5) | 5.4 (0.5) | 5.5 (0.6) | -0.1 (4.3) | -0.9, 0.8 | -0.10 | 48.5 | .919 |
| Cholesterol (mmol/L) | 4.9 (0.2) | 4.8 (0.2) | 5.5 (0.2) | 5.2 (0.2) | -0.2 (0.2) | -0.5, 0.2 | -1.08 | 47.7 | .287 |
| Triglycerides (mmol/L) | 1.3 (0.2) | 1.2 (0.2) | 1.4 (0.2) | 1.5 (0.2) | 0.2 (0.2) | -0.3, 0.7 | 0.88 | 53.4 | .386 |
| HDL cholesterol (mmol/L) | -1.5 (0.1) | 1.5 (0.1) | 1.4 (0.1) | 1.3 (0.1) | -0.1 (0.1) | -0.2, 0.1 | -1.11 | 47.7 | .272 |
| LDL cholesterol (mmol/L) | 2.9 (0.2) | 2.8 (0.1) | 3.4 (0.2) | 3.2 (0.2) | -0.1 (0.2) | -0.4, 0.3 | -0.48 | 47.1 | .636 |
| Total saturates (% FA) | 35.7 (0.5) | 36.6 (0.5) | 35.6 (0.5) | 38.1 (0.6) | 1.6 (1.0) | -0.5, 3.6 | 1.54 | 62.1 | .128 |
| Total monounsaturates (% FA) | 23.2 (0.4) | 22.2 (0.5) | 22.8 (0.4) | 23.2 (0.6) | 1.4 (0.8) | -0.3, 3.1 | 1.69 | 55.4 | .096 |
| Total polyunsaturates (% FA) | 41.1 (0.7) | 41.3 (0.8) | 41.6 (0.7) | 38.6 (0.9) | -3.1 (1.3) | -5.7, 0.5 | -2.41 | 54.9 | .019 |
| n6 (% PUFA) | 14.6 (0.4) | 14.5 (0.4) | 14.3 (0.4) | 12.8 (0.5) | -1.4 (0.8) | -3.0, 0.3 | -1.69 | 62.1 | .096 |
| n3 (% PUFA) | 6.9 (0.3) | 6.8 (0.3) | 6.5 (0.3) | 7.2 (0.4) | 0.9 (0.6) | -0.3, 2.1 | 1.57 | 57.8 | .123 |
MADRS Montgomery-Åsberg Depression Rating Scale, HADS Hospital Anxiety and Depression Scale, POMS Profile of Mood States, GSE Generalized Self-Efficacy scale, WHO-5 WHO (Five) wellbeing index, BMI body mass index, FA fatty acids, PUFA polyunsaturated fatty acids
aDerived from planned comparison within mixed model repeated measures (MMRM) using all available data (baseline data n = 67, 12 week data n = 56) and based on unadjusted estimates