Mobile health intervention for dementia prevention through lifestyle optimisatio

Not Applicable

• Conditions: owering dementia risk factors in people with elevated dementia risk; Mental and Behavioural Disorders

• Registration Number: ISRCTN92928122
• Lead Sponsor: Amsterdam University Medical Centers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Last Update Posted: 8 July 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 692

Inclusion Criteria

Current inclusion criteria as of 05/06/2024:

1. Age =50 years =75 years
2. Basic level of literacy in Dutch
3. Possession of a smartphone
4. Turkish or South-Asian Surinamese background; OR Dutch background with low SES, operationalised using educational level and occupational status
5. Increased risk of dementia based on = one dementia risk factor defined as:
5.1. Hypertension, defined by any of the following:
5.1.1. Diagnosis by specialist or general practitioner.
5.1.2. Currently on anti-hypertensive drugs.
5.1.3. Baseline blood pressure: =140/90 mmHg;
5.2. Dyslipidaemia, defined by any of the following:
5.2.1. Diagnosis by specialist or general practitioner
5.2.2. Use of lipid-lowering drugs
5.2.3. Baseline total cholesterol =5.0 mmol/L
5.3. Diabetes mellitus, defined by any of the following:
5.3.1. Diagnosis by specialist or general practitioner
5.3.2. Use of any blood glucose-lowering medication
5.4. Active smoking (use of any sort of tobacco in any quantity)
5.5. Overweight, defined by any of the following:
5.5.1. Body mass index (BMI) =30 kg/m²
5.5.2. Waist circumference men =102 cm, women =88 cm
5.6. Lack of physical exercise, defined as below the World Health Organization (WHO) norm (five times a week 30 minutes or a total of 150 minutes per week of intermediate exercise)
5.7. Depression
5.7.1. Currently on anti-depressive medication or receiving psychotherapy for depression
5.7.2. History of treatment (i.e. drug therapy or psychotherapy) for depression OR Manifest cardiovascular disease, as diagnosed by specialist or general practitioner

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Previous inclusion criteria:

1. Age =50 years =75 years
2. Basic level of literacy in Dutch
3. Possession of a smartphone
4. Turkish or South-Asian Surinamese background; OR Dutch background with low SES, operationalised using educational level and occupational status
5. Increased risk of dementia based on = one dementia risk factor defined as:
5.1. Hypertension, defined by any of the following:
5.1.1. Diagnosis by specialist or general practitioner.
5.1.2. Currently on anti-hypertensive drugs.
5.1.3. Baseline blood pressure: =140/90 mmHg;
5.2. Dyslipidaemia, defined by any of the following:
5.2.1. Diagnosis by specialist or general practitioner
5.2.2. Use of lipid-lowering drugs
5.2.3. Baseline total cholesterol =5.0 mmol/L
5.3. Diabetes mellitus, defined by any of the following:
5.3.1. Diagnosis by specialist or general practitioner
5.3.2. Use of any blood glucose-lowering medication
5.4. Active smoking (use of any sort of tobacco in any quantity)
5.5. Overweight, defined by any of the following:
5.5.1. Body mass index (BMI) =25 kg/m²
5.5.2. Waist circumference men =102 cm, women =88 cm
5.6. Lack of physical exercise, defined as below the World Health Organization (WHO) norm (five times a week 30 minutes or a total of 150 minutes per week of intermediate exercise)
5.7. Depression
5.7.1. Current depression
5.7.2. Currently on anti-depressive medication or receiving psychotherapy for depression
5.7.3. History of treatment (i.e. drug therapy or psychotherapy) for depression OR Manifest cardiovascular disease, as diagnosed by specialist or general practitioner

Exclusion Criteria

1. Diagnosed with dementia by a specialist or general practitioner
2. A score below 21 on the Rowland Universal Dementia Assessment Scale (RUDAS) validated dementia screening method specifically developed to be less susceptible to cultural, linguistic, and educational biases
3. Any condition expected to limit 12 months of compliance and follow-up, including metastasised malignancy or other terminal illness
4. Any impairment interfering with the operation of a smartphone
5. Participating in another RCT on lifestyle behavioural change
6. Present alcohol or illicit drug abuse impairing study participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified