Dutch multidomain lifestyle intervention in older adults at risk of cognitive decline

Recruiting

Conditions: risicofactoren voor verminderd cognitief functioneren
brain health
cognitive functioning
10024450

Registration Number: NL-OMON52236

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1206

Inclusion Criteria

- 60-79 years of age at pre-screening;
- Adequate fluency in Dutch to understand the informed consent and complete
(online) questionnaires ;
- Providing informed consent to all study procedures;
- Internet access at home
- >=3 (self-reported) risk factors (must contain at least 2 modifiable risk
factors and 1 non-modifiable risk factor):
Modifiable risk factors:
- Physical inactivity (1)
- Unhealthy diet (1)
- Low mental/cognitive activity (1)
- High blood pressure (1)
- High cholesterol (1)
- High body mass index (BMI) (2)
Non-modifiable risk factors:
- First-degree family history of dementia
- Subjective cognitive decline/memory complaints
(1) Measured using LIBRA questionnaire;
(2) Defined as >=25 kg/m2 for 60-69 years old, and >=28 kg/m2 for >=70 years old,
based on self-reported height and weight.

Exclusion Criteria

1. Diagnosis of dementia or mild cognitive impairment at baseline
(self-reported);
2. Significant cognitive impairment assessed using a validated
telephone-administered cognitive battery (TICSm score<23).
3. Conditions affecting safe and continuous engagement in the intervention
(e.g. under treatment for current malignant diseases, major psychiatric
disorders (e.g. major depression, psychosis, bipolar disorder), neurological
disorders (e.g. Parkinson*s disease, multiple sclerosis), symptomatic
cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial
infarction), re-vascularization within three months, severe loss of vision,
hearing or communicative ability, severe mobility impairment, other conditions
preventing co-operation) as judged by the local study nurse or consulted
physician at the local study site;
4. Coincident participation in any other intervention trial at time of
pre-screening.
5. Coincident participation of spouse/partner in the FINGER-NL trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>2-year change from baseline in global cognitive composite score derived from<br /><br>subtest scores from the Neuropsychological Test Battery (NTB) that includes<br /><br>15-Word Verbal Learning Test delayed recall, DDST 90 seconds, WAIS digit span<br /><br>backwards, and semantic fluency.</p><br>

Secondary Outcome Measures