Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
研究概览
简要总结
In the future, we plan to conduct an 8-week diet intervention to investigate whether a healthy Nordic diet improves depression symptoms. The present pilot study tested whether the planned meals and diets were well-liked and accepted by participants (both depressed and non-depressed) in order to ensure that the future diet intervention will be feasible and successful. We also investigated whether any changes in health occurred after 8 days of this diet intervention.
详细描述
After providing their written informed consent, participants were randomized to receive either a healthy Nordic diet or a control diet for 8 days. All meals were provided and minimal food preparation was required. Participants picked up their food outside the study kitchen every 3 days. Before and after the intervention, health-related self-rated questionnaires were completed. For every meal during the intervention, participants completed a questionnaire on their perceptions of the meal. Every evening a questionnaire was completed to assess dietary adherence. At the end of the study, a final evaluation questionnaire was completed to assess participants' perceptions of the diet and study as a whole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •If depressed, a score between 13 and 34 on the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S), indicating mild or moderate depression
排除标准
- •A score of 8 or higher (out of a maximum of 12 points) on a brief diet survey (the retired version of the Swedish Food Agency's online Matvanekollen, conducted via phone interview), indicating a relatively healthy habitual diet
- •Presence of food allergies, intolerances or sensitivities
- •Consuming any form of special diet that excludes certain foods, for example a vegetarian or gluten-free diet
- •Suicidality, indicated by a score of 4 or higher on the MADRS-S suicidality question.
结局指标
主要结局
Median rating of the liking of all meals as assessed by a Likert item (the Hedonic scale)
时间窗: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the appearance of all meals as assessed by an original Likert item
时间窗: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the smell of all meals as assessed by an original Likert item
时间窗: 8 days
1=Dislike very much, and 7=Like very much. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of feelings of fullness after the meals as assessed by an original visual analog scale (VAS)
时间窗: 8 days
0=Not at all full, and 100=Have never felt so full. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the extent to which the smell matches the appearance of the meals as assessed by an original Likert item
时间窗: 8 days
1=Doesn't match at all, and 5=Matches very well. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Total amount of non-study foods consumed as assessed by self-report on a questionnaire every evening
时间窗: 8 days
Total amount of provided juice drink not consumed as assessed by self-report on a questionnaire every evening.
时间窗: 8 days
Applies to the CD group only.
Rating of how easy it would be to participate in such a study, with meals recurring every 8 days for 8 weeks (but not having to fill out a questionnaire for the meals)
时间窗: 8 days
Assessed by an original Likert item on the final questionnaire where 1=It would be very hard, and 7=It would be very easy
Median rating of the taste intensity of all meals as assessed by a Just About Right (JAR) scale
时间窗: 8 days
1=Much too low, 3=Just right, and 5=Much too high. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median rating of the portion size of all meals as assessed by a Just About Right (JAR) scale
时间窗: 8 days
1=Much too small, 4=Just right, and 7=Much too big. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Median perception of healthiness of all meals as assessed by an original visual analog scale (VAS)
时间窗: 8 days
0=Not at all healthy, and 100=Very healthy. Median of responses for all meals for each participant calculated first, and then the median of those medians calculated and reported for each diet group.
Total amount of non-study drinks consumed as assessed by self-report on a questionnaire every evening
时间窗: 8 days
Rating of how easy it was to follow the protocol, as assessed by an original Likert item on the final questionnaire
时间窗: 8 days
1=It was very hard, and 7=It was very easy
次要结局
- Change in work impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire(8 days)
- Change in indigestion symptom severity after 8 days, as assessed by the indigestion sub-score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire(8 days)
- Change in physical activity level after 8 days, as assessed by the Frändin-Grimby Physical Activity Scale(8 days)
- Change in activity impairment after 8 days, as calculated from questions of the Work Productivity and Activity Impairment (WPAI) questionnaire(8 days)
- Change in gastrointestinal symptom severity after 8 days, as assessed by the total mean score of the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire(8 days)
- Change in depression severity after 8 days, as assessed by the total score of the Montgomery-Åsberg Depression Rating Scale, self-rated (MADRS-S) questionnaire(8 days)
- Self-reported change in health after 8 days, as assessed by a written open-ended response on the final questionnaire(8 days)
- Change in body weight after 8 days, as assessed by self-measurement or approximation(8 days)
- Change in general health after 8 days, as assessed by the summary index value calculated from the questions of the EuroQol Health-Related Quality of Life (EQ-5D-5L) questionnaire(8 days)
- Change in perceived general health status after 8 days, as assessed by the visual analog scale (VAS) question of the EuroQol Health-Related Quality of Life (EQ-5D-5L) questionnaire(8 days)