Nutrition-based Interventions to Prevent Cognitive Decline
NCT ID: NCT06853405
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-01-27
2026-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Nutrition-related lifestyle group sessions
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).
Cognitive training
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.
Clinical nutrition consultations
A registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period.
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.
No interventions assigned to this group
Interventions
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Nutrition-related lifestyle group sessions
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).
Cognitive training
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.
Clinical nutrition consultations
A registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
55 Years
85 Years
ALL
No
Sponsors
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Instituto de Saude Publica da Universidade do Porto
OTHER
Responsible Party
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Locations
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Instituto de Saúde Pública da Universidade do Porto
Porto, Portugal, Portugal
Faculty of Nutrition and Food Sciences, University of Porto
Porto, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NUTRIMIND_2024
Identifier Type: -
Identifier Source: org_study_id
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