mHealth Intervention for Dementia Prevention through lifestyle Optimisation (MIND-PRO): a hybrid effectiveness-implementation randomized controlled trial in middle-aged persons with low SES and/or migration background
Lowering dementia risk factors in people with elevated dementia risk
Current interventions as of 19/06/2024: Randomization will take place in the app using a computer algorithm in a 1:1 manner. Participants will be informed that random allocation will be to one of two different smartphone apps and that the study is on improving lifestyle to reduce dementia risk factors. Partners who also participate in MIND-PRO will automatically be allocated to the same treatment arm, to avoid contamination. The intervention is aimed at lifestyle behavioural change using a mHealth intervention (app), supported by a coach. Participants randomized to the intervention arm will have access to an interactive mobile app that facilitates self-management of dementia risk factors (hypertension, dyslipidaemia, active smoking, overweight, lack of physical exercise). After secure login, the app shows the participants’ dementia risk profile, based on baseline assessment. Participants can set goals for lifestyle change, monitor these goals, and enter self-measurements of for example weight, blood pressure and physical exercise. Furthermore, the app contains evidence-based education modules (both static and interactive), educational videos which will be developed within the project, and news items that are arranged according to personal risk factors. The participants will be supported by an experienced lifestyle coach trained in motivational interviewing who will be matched to the ethnicity of the participants as much as possible. The coaches will use motivational interviewing to help participants to formulate simple, measurable, achievable, realistic and time-bound (SMART) goals and guide the process to achieve the goals. Participants randomized to the control condition will have access to an app which is similar in appearance but lacks any interactive features and does not provide coach support. It will contain general information on how to live a healthy lifestyle. The intervention and follow-up are 12 months for the intervention and control group. (added
Current key inclusion criteria as of 30/06/2026: 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// as of june 2026 also African Surinamese background; OR Chinese Mandrin speaking population (mainland China, Taiwan, and Hong Kong). 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 _____ Previous 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 occupatio
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