Nutrition-based Interventions to Prevent Cognitive Decline

Official title

NUTRIMIND: Nutrition-based Interventions to Prevent Cognitive Decline

Overview

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.

Detailed description

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.

Interventions

• Behavioral 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
• Behavioral 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.
• Behavioral Clinical nutrition consultations
  A registered nutritionist will conduct individualized clinical nutrition consultations to each participant three times over the course of the study period.

Primary outcome measures

• Self-reported adherence to the Mediterranean Diet [Time frame: Up to 6 months]
• Self-reported quality of life [Time frame: Up to 6 months]

Secondary outcome measures (12)

• Self-reported memory complaints [Time frame: Up to 6 months]
• Cognitive performance 1 [Time frame: Up to 6 months]
• Cognitive performance 2 [Time frame: Up to 6 months]
• Anxiety and depression symptoms [Time frame: Up to 6 months]
• Blood Pressure [Time frame: Up to 6 months]
• Body Mass Index [Time frame: Up to 6 months]
• Self-reported physical activity [Time frame: Up to 6 months]
• Health Literacy [Time frame: Up to 6 months]
• Nutrition Knowledge on Mediterranean Diet for Cardiovascular Disease [Time frame: Up to 6 months]
• Adherence to each intervention [Time frame: Up to 6 months]
• Dropout [Time frame: Up to 6 months]
• Time of follow-up [Time frame: Up to 6 months]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Portugal · 2 centers

• Instituto de Saúde Pública da Universidade do Porto — Porto
• Faculty of Nutrition and Food Sciences, University of Porto — Porto

Identifiers

NCT: NCT06853405 · NUTRIMIND_2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗