Effect of Multinutrient Supplementation and Food-Related Behavioral Activation Therapy on Prevention of Major Depressive Disorder Among Overweight or Obese Adults With Subsyndromal Depressive Symptoms The MooDFOOD Randomized Clinical Trial
Effect of Multinutrient Supplementation and Food-Related Behavioral Activation Therapy on Prevention of Major Depressive Disorder Among Overweight or Obese Adults With Subsyndromal Depressive Symptoms The MooDFOOD Randomized Clinical Trial
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DOI：
10.1001/jama.2019.0556
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发表时间：
2019-03-05
影响因子：
120.7
通讯作者：
Mauche, Nicole
中科院分区：
文献类型：
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作者：
Bot, Mariska;Brouwer, Ingeborg A.;Mauche, Nicole
营养干预对预防超重成人重度抑郁症 (MDD) 的重要性尚不清楚。目的 检验 2 种营养策略（多营养素补充、食物相关行为激活疗法）及其组合对于预防患有亚综合征抑郁症状的超重成人新发 MDD 发作的效果。设计、设置和参与者这个多中心 2 x 2 析因随机临床试验包括来自 4 个欧洲国家的超重成年人（体重指数为 25-40），且抑郁症状加重（患者健康问卷 9 [PHQ-9] 评分 >= 5）且过去 6 个月内没有 MDD 发作。共有 1025 名成年人被随机分组（2015 年 7 月 30 日至 2016 年 10 月 12 日），并随访 1 年（2017 年 10 月 13 日）。 干预措施 每日多种营养素补充剂（1412 毫克 omega-3 脂肪酸、30 微克硒、400 微克叶酸和 20 微克维生素 D-3加 100 毫克钙）对比安慰剂和 21 次个人或团体治疗疗程 与一年内没有（对研究人员不知情）的比较。参与者被分配到未经治疗的安慰剂组 (n = 257)、接受治疗的安慰剂组 (n = 256)、未经治疗的补充剂组 (n = 256) 和接受治疗的补充剂组 (n = 256)。 主要结果和测量 通过第 3、6 和 12 个月的小型国际神经精神病学访谈得出 MDD 的 1 年累积发病情况。使用效果编码变量（-1 表示对照，1 表示干预）的逻辑回归评估了单独和组合（相互作用）对 MDD 发作的干预效果。 结果 在 1025 名参与者（平均 46.5 岁；772 名女性 [75%]；平均 BMI，31.4）中，779 名 (76%) 完成了试验。在 12 个月的随访期间，105 名患者（10%）出现了 MDD：安慰剂组中有 25 名患者（9.7%）未经治疗，接受治疗的安慰剂组有 26 名患者（10.2%），未经治疗的补充剂组有 32 名患者（12.5%），接受治疗的补充剂组有 22 名患者（8.6%）。所有治疗策略均不影响重度抑郁症的发作。补充剂的比值比 (OR) 为 1.06 (95% CI, 0.87-1.29)；对于治疗，0.93（95% CI，0.76-1.13）；它们的组合为 0.93（95% CI，0.76-1.14；交互作用 P，0.48）。补充治疗组中的一名患者死亡。每个安慰剂组有 24 名患者住院，补充治疗组有 24 名患者住院，仅补充治疗组有 26 名患者住院。结论和相关性在患有亚综合征抑郁症状的超重或肥胖成人中，与安慰剂相比，多营养素补充剂以及与不治疗相比，食物相关行为激活疗法并没有减少 1 年内重度抑郁症的发作。这些发现不支持使用这些干预措施来预防重度抑郁症。
IMPORTANCE Effects of nutritional interventions on the prevention of major depressive disorder (MDD) in overweight adults are unknown.OBJECTIVE To examine the effect of 2 nutritional strategies (multinutrient supplementation, food-related behavioral activation therapy) and their combination for prevention of a new MDD episode in overweight adults with subsyndromal depressive symptoms.DESIGN, SETTING, AND PARTICIPANTS This multicenter 2 x 2 factorial randomized clinical trial included overweight adults (body mass index, 25-40) with elevated depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores >= 5) and no MDD episode in the past 6 months from 4 European countries. A total of 1025 adults were randomized (July 30, 2015-October 12, 2016) and followed up for 1 year (October 13, 2017).INTERVENTIONS Daily multinutrient supplements (1412-mg omega-3 fatty acids, 30-mu g selenium, 400-mu g folic acid, and 20-mu g vitamin D-3 plus 100-mg calcium) vs placebo and 21 individual or group therapy sessions vs none (blinded to researchers) for 1 year. Participants were allocated to placebo without therapy (n = 257), placebo with therapy (n = 256), supplements without therapy (n = 256), and supplements with therapy (n = 256).MAIN OUTCOME AND MEASURES Cumulative 1-year onset of MDD via the Mini International Neuropsychiatric Interview at 3, 6, and 12 months. Logistic regression using effect-coded variables (-1 indicating control, 1 indicating intervention) evaluated intervention effects both individually and in combination (interaction) on MDD onset.RESULTS Among 1025 participants (meanage, 46.5 years; 772 women [75%]; mean BMI, 31.4), 779 (76%) completed the trial. During the 12-month follow-up, 105 (10%) developed MDD: 25 (9.7%) patients in the placebo without therapy, 26 (10.2%) in the placebo with therapy, 32 (12.5%) in the supplement without therapy, and 22 (8.6%) in the supplement with therapy group. None of the treatment strategies affected MDD onset. The odds ratio (OR) for supplements was 1.06 (95% CI, 0.87-1.29); for therapy, 0.93 (95% CI, 0.76-1.13); and for their combination, 0.93 (95% CI, 0.76-1.14; P for interaction, .48). One person in the supplementation with therapy group, died. Twenty-four patients in each of the placebo groups and 24 patients in the supplementation with therapy group were hospitalized, and 26 patients in the supplementation-only group were hospitalized.CONCLUSIONS AND RELEVANCE Among overweight or obese adults with subsyndromal depressive symptoms, multinutrient supplementation compared with placebo and food-related behavioral activation therapy compared with no therapy did not reduce episodes of major depressive disorder during 1 year. These findings do not support the use of these interventions for prevention of major depressive disorder.