An interventional study of Nutrition-related lifestyle group sessions and Cognitive training in Cognitive Dysfunction, Cognition Disorder and Memory Disorders, sponsored by Instituto de Saude Publica da Universidade do Porto. Recruiting at 2 sites in Portugal. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Instituto de Saude Publica da Universidade do Porto · Not applicable, Interventional, and Prevention
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.
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.
Participants' assessments will be performed at baseline and will be repeated at the end of intervention (6 months after the beginning of the intervention). A follow-up assessment will be conducted 6 months after the intervention concludes. Adherence outcomes, as well as lifestyle, health and anthropometric data, cognitive performance, subjective memory complaints, anxiety and depression, quality of life and self-reported physical activity will be evaluated.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 120 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Instituto de Saude Publica da Universidade do Porto is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Nutrition-related lifestyle group sessions · Behavioral: Cognitive training · Behavioral: Clinical nutrition consultations
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.
In person lifestyle group sessions of 180-minutes per week, directed by a nutritionist, and comprising: 1. nutrition education session for preparing healthy meals, followed by a period of social interaction while consuming the meals prepared. Participants will be encouraged to apply the healthy cooking techniques covered in each session in their home context. 2. daily activities to reduce physical inactivity (e.g., walking to the supermarket to buy ingredients, playing traditional games, caring for community gardening, among others).
Individualized cognitive training performed remotely, at home on their own. The participants will be invited to perform cognitive training exercises at least twice a week using COGWEB®, an online platform for cognitive training. For those unable to use computer devices, similar exercises will be available in paper-and-pencil format.
A registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period.
Self-reported adherence to the Mediterranean Diet
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.
Time frame: Up to 6 months
Self-reported quality of life
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).
Time frame: Up to 6 months
Self-reported memory complaints
Variation of the self-reported memory complaints, assessed using the Subjective Memory Complaints Scale, between the baseline assessment and the end of the intervention. This scale varies from 0 (best score) to 21 points (worst score). Scores \> 3 points indicate the presence of self-reported memory complaints.
Time frame: Up to 6 months
Cognitive performance 1
Participant's cognitive performance assessed using the Montreal Cognitive Assessment, between the baseline assessment and the end of the intervention. In this scale the worst cognitive performance is equal to 0 and the best cognitive performance is equal to 30 points.
Time frame: Up to 6 months
Cognitive performance 2
Variation of participant's cognitive performance assessed using the Portuguese version of Addenbrooke's Cognitive Examination - Revised (ACE-R), between the baseline assessment and the end of the intervention. This brief test evaluates the following cognitive subdomains: attention and orientation, memory, fluency, language and visuospatial. The test is scored from 0 to 100 points (highest possible score). Higher scores will indicate better cognitive performance.
Time frame: Up to 6 months
Anxiety and depression symptoms
Variation of the anxiety and depression scores, assessed using the Hospital Anxiety and Depression Scale (HADS), between the baseline assessment and the end of the intervention. This scale varies from 0 (best score) to 21 points (worst score).
Time frame: Up to 6 months
Blood Pressure
Variation of participant's systolic and diastolic blood pressure, between the baseline evaluation and the end of the intervention.
Time frame: Up to 6 months
Body Mass Index
Variation of participant's body mass index between the baseline assessment and the end of the intervention.
Time frame: Up to 6 months
Self-reported physical activity
Variation of participants' self-reported physical activity using the short version of the International Physical Activity Questionnaire (IPAQ), between baseline and the end of the intervention. Participants will be classified into 3 levels of physical activity: inactive, minimally active and active.
Time frame: Up to 6 months
Health Literacy
Variation of participant's health literacy Portuguese validated version of the NVS - Newest Vital Sign between baseline assessment and the end of the intervention. The NVS includes six questions regarding an ice cream nutrition label. The scores range from 0 to 6 (1 point for each correct answer): a score of 0 - 1 suggests high likelihood of limited literacy; 2 - 3 indicates the possibility of limited literacy; and 4 - 6 almost always indicates adequate literacy.
Time frame: Up to 6 months
Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease
Variation of participants' nutrition knowledge about Mediterranean Diet and its health benefits between baseline assessment and the end of the intervention. The nutrition knowledge will be assessed using a 20-item tool, the Mediterranean Diet Nutrition Knowledge Questionnaire (Med-NKQ). In total, the tool score range from 0 to 42, with a higher score indicating greater knowledge.
Time frame: Up to 6 months
Adherence to each intervention
Proportion of adherence to each intervention, calculated as the number of sessions attended divided by the total number of sessions implemented.
Time frame: Up to 6 months
Dropout
Proportion of participants who dropped out of the study, calculated as the number of participants who dropped out after attending at least one session divided by the total number of participants who attended at least one session.
Time frame: Up to 6 months
Time of follow-up
Number of days between the first and the last session attended by the participant.
Time frame: Up to 6 months
Implemented sessions
Proportion of sessions implemented, calculated as the number of sessions that the research team was able to implement divided by the total number of sessions planned.
Time frame: Up to 6 months
Complete assessment of participants
For each study outcome, proportion of participants with complete information, calculated at baseline and different moments of follow-up, as the number of participants with complete information divided by the total number of participants evaluated.
Time frame: Up to 12 months
Plan to share: Undecided
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Instituto de Saude Publica da Universidade do Porto