The Effects of a Multidomain Lifestyle Intervention on Brain Functioning and Its Relation With Immunometabolic Markers in Ageing (HELI)

Donders Centre for Cognitive Neuroimaging

Status: Completed

Conditions: Aging; Life Style; Cognitive Decline; Risk Reduction

Treatments: Behavioral: Multidomain lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05777863

3033003.01

Details and patient eligibility

About

HELI is a multicenter, randomised controlled trial in two Dutch research centres (Donders Centre for Cognitive Neuroimaging, Nijmegen, and the department of Human Nutrition & Health at Wageningen University) among 104 older adults aged 60-75 years who are at risk for cognitive decline with an intervention duration of 26 weeks (roughly 6 months). Participants are randomized in a 1:1 ratio to a multidomain lifestyle intervention characterized by group-sessions and guidance (high-intensity intervention group) versus online access to general lifestyle-related health information in the form of biweekly leaflets (low-intensity intervention group).

Enrollment: 102 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent;
• Age between 60-75 years (at pre-screening);
• Fluency in Dutch (speaking, reading and writing);
• Lives near study centres in Nijmegen and Wageningen (max. 50 kilometers of travelling, to ensure study centre visits are possible without excessive travel burden);
• Presence of ≥2 self-reported risk factors for cognitive decline (BMI of 30 or higher, physical inactivity according to World Health Organization guidelines, hypertension [not using hypertensive drugs counts as an additional risk factor], hypercholesterolemia, diabetes type-II, non-symptomatic cardiovascular disease).

Exclusion criteria

• Concurrent participation in other intervention trials;
• Technologically illiterate (complete incompetence in working with computers, apps, online questionnaires, etc.);
• No internet access from home;
• Clinical diagnosis of ≥1 of the following: vascular event (CVA), neurological pathology (e.g. mild cognitive impairment, dementia, multiple sclerosis, Parkinson's, epilepsy), current malignant disease(s) (with or without current treatment), current psychiatric disorder(s) (e.g. depression, psychosis, bipolar episodes), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), revascularisation surgery in the last 12 months at pre-screening, inflammatory bowel disease (characterised with diarrhoea), visual impairment (e.g. blindness), hearing or communicative impairment;
• Unable to undergo MRI (e.g. metal objects in upper body, past brain surgery, active implants, claustrophobic);
• Cognitive impairment as determined by the Telephone Interview for Cognitive Status (TICS-M1), performed during pre-screening before inclusion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

102 participants in 2 patient groups

High-intensity group

Experimental group

Description:

The high-intensity group receives a supervised multidomain lifestyle intervention consisting of weekly group meetings. During the weekly group meetings, information and exercises are provided, and participants are able to exchange experiences and advice with other group members.

Treatment:

Behavioral: Multidomain lifestyle intervention

Low-intensity group

No Intervention group

Description:

The low-intensity group only receives access to general lifestyle-related health information through biweekly leaflets, which are provided through e-mail.