Nutrition-based Interventions to Prevent Cognitive Decline (NUTRIMIND)

Instituto de Saude Publica da Universidade do Porto

Status: Enrolling

Conditions: Cognitive Impairment; Memory Disorders; Cognition Disorder; Cognitive Dysfunction; Neurocognitive Disorders

Treatments: Behavioral: Cognitive training; Behavioral: Nutrition-related lifestyle group sessions; Behavioral: Clinical nutrition consultations

Study type: Interventional

Funder types: Other

Identifiers

NCT06853405

NUTRIMIND_2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

NUTRIMIND

Experimental group

Description:

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.

Treatment:

Behavioral: Clinical nutrition consultations

Behavioral: Nutrition-related lifestyle group sessions

Behavioral: Cognitive training

Control

No Intervention group

Description:

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.