NUTRIMIND: Nutrition-based Interventions to Prevent Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Self-reported adherence to the Mediterranean Diet
研究概览
简要总结
This study intends to evaluate the feasibility and the effectiveness of an innovative and integrated nutrition-based intervention addressing key modifiable risk factors for dementia while meeting participants' preferences for nutrition-related sessions. The intervention will include lifestyle group sessions regarding nutrition education and physical activity, individualized cognitive training at home, as well as clinical nutrition consultations.
详细描述
The present project is a randomized controlled trial (RCT) to study the feasibility and effectiveness of a 6-month nutrition-based intervention designed to prevent cognitive decline in adults at higher risk of dementia.
Eligible individuals (n=120) recruited at primary health care centers or in the community will be randomized (1:1) into two arms: intervention and control groups.
The intervention group will be invited to participate in nutrition-based sessions of 180-minutes per week, directed by a nutritionist, to improve participants' skills in preparing healthy meals and reduce sedentary behaviours. Participants will also be asked to perform cognitive training at home and to attend individualized clinical nutrition consultations.
The control group will participate in data assessment and will receive a healthy recipes cookbook to thank for their participation. They will also receive an invitation to participate in free healthy cooking workshops, which will be offered upon the completion of the primary data collection endpoint.
Both groups will continue receiving the usual standard care in their healthcare unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The principal investigator will generate the randomization sequence, will inform the participants of their allocation group and will be responsible for the intervention's sessions. The assessors will not know each participants' allocation group.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 55 to 85 years old;
- •At least 4 years in the regular school system;
- •Higher individual risk for dementia defined as a score ≥6 points on the Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score (CAIDE).
排除标准
- •Montreal Cognitive Assessment (MoCA) score lower than the validated cutoff points defined as 2 standard deviations below the normative reference value for the corresponding age and education in the Portuguese population;
- •Having a medical condition limiting the participation in the intervention (e.g., blindness, amputation…);
- •Lack of autonomy in daily activities;
- •Diagnosis of dementia or major incapacity.
研究组 & 干预措施
NUTRIMIND
The NUTRIMIND arm will be invited to receive a multidomain nutrition-based intervention to prevent cognitive decline, including lifestyle group sessions of nutrition education, daily activities to reduce physical inactivity, as well as individualized cognitive training and individualized clinical nutrition consultations. They will continue receiving the usual standard care in their healthcare unit.
干预措施: Nutrition-related lifestyle group sessions (Behavioral)
NUTRIMIND
The NUTRIMIND arm will be invited to receive a multidomain nutrition-based intervention to prevent cognitive decline, including lifestyle group sessions of nutrition education, daily activities to reduce physical inactivity, as well as individualized cognitive training and individualized clinical nutrition consultations. They will continue receiving the usual standard care in their healthcare unit.
干预措施: Cognitive training (Behavioral)
NUTRIMIND
The NUTRIMIND arm will be invited to receive a multidomain nutrition-based intervention to prevent cognitive decline, including lifestyle group sessions of nutrition education, daily activities to reduce physical inactivity, as well as individualized cognitive training and individualized clinical nutrition consultations. They will continue receiving the usual standard care in their healthcare unit.
干预措施: Clinical nutrition consultations (Behavioral)
Control
The control arm will receive a healthy recipe cookbook and will also be invited to attend free healthy cooking workshops after the data collection phase concludes. And will continue receiving the usual standard care in their healthcare unit.
结局指标
主要结局
Self-reported adherence to the Mediterranean Diet
时间窗: Up to 6 months
Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern scale (MEDAS), between the baseline assessment and the end of the intervention. This scale varies from 0 (lowest adherence to the Mediterranean diet) to 14 points (highest adherence to the Mediterranean diet). A score ≥ 10 points indicates good adherence to the Mediterranean diet.
Self-reported quality of life
时间窗: Up to 6 months
Variation of participant's quality of life, assessed using the EuroQol Group scale - 5 dimensions (EQ-5D) scale, between the baseline assessment and the end of the intervention. This scale is subdivided into two subscales: a) five multiple choice questions, with five response possibilities, which produce a score that varies from 5 (best score) to 25 points (worst score); b) visual analogic scale, that varies from 0 (worst score) to 100 (best score).
次要结局
- Self-reported memory complaints(Up to 6 months)
- Cognitive performance 1(Up to 6 months)
- Cognitive performance 2(Up to 6 months)
- Anxiety and depression symptoms(Up to 6 months)
- Blood Pressure(Up to 6 months)
- Body Mass Index(Up to 6 months)
- Self-reported physical activity(Up to 6 months)
- Health Literacy(Up to 6 months)
- Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease(Up to 6 months)
- Adherence to each intervention(Up to 6 months)
- Dropout(Up to 6 months)
- Time of follow-up(Up to 6 months)
- Implemented sessions(Up to 6 months)
- Complete assessment of participants(Up to 12 months)