Mobile health intervention for dementia prevention through lifestyle optimisation
| ISRCTN | ISRCTN92928122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92928122 |
- Submission date
- 28/12/2023
- Registration date
- 04/03/2024
- Last edited
- 04/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
Reducing risk factors for dementia is increasingly important in light of its rising prevalence in the coming decades, particularly among lower socioeconomic status (SES) and migrant populations. The aim of this study is to evaluate the effectiveness and implementation of an mHealth lifestyle intervention to optimize brain health and reduce dementia risk factors through self-management with remote coaching.
Who can participate?
People aged 50-75 years who are of low socio-economic status and/or have a migration background (Turkish or South-Asian Surinamese), and have one or more dementia risk factors or cardiovascular (heart) disease
What does the study involve?
Participants are randomly allocated to a coach-supported, interactive app facilitating self-management of dementia risk factors (including hypertension, dyslipidemia, physical inactivity, smoking, and overweight) or to a control app with static health information. Blood pressure, total cholesterol, and BMI are measured, as well as the coverage, acceptability, adoption, appropriateness, feasibility, fidelity, and sustainability of the intervention, and dementia risk score, individual risk factors, and cost-effectiveness.
Where is the study run from?
Amsterdam UMC (Netherlands)
When is the study starting and how long is it expected to run for?
January 2023 to December 2026
Who is funding the study?
ZonMw (Netherlands)
Main contact:
Edo Richard, e.richard@amsterdamumc.nl
Contact information
Prof Edo Richard
Public, Scientific, Principal Investigator
Public, Scientific, Principal Investigator
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
 ORCID ID |
0000-0002-7250-3390 |
|---|---|
| Phone | +31 (0)20 566 9111 |
| e.richard@amsterdamumc.nl |
Study information
| Study design | Single-center investigator initiated prospective randomized open-label blinded endpoint (PROBE) trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | 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 |
| Study acronym | MIND-PRO |
| Study objectives | The intervention is effective in reducing dementia risk factors and can be implemented to reduce dementia risk factors. |
| Ethics approval(s) |
Approved 30/01/2024, METC Amsterdam UMC (Meibergdreef 9, Amsterdam, 1105AZ, Netherlands; +31 (0)20 444 55 85; metc@vumc.nl), ref: 2023.0770 |
| Health condition(s) or problem(s) studied | Lowering dementia risk factors in people with elevated dementia risk |
| Intervention | 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. Previous interventions: Randomization will take place in the app using a computer algorithm in a 1:1 manner, stratified by ethnicity. 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. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 05/06/2024: All effectiveness outcomes are measured at baseline and at the study end after 12 months. 1. The primary effectiveness outcome will be a composite score of the objectively measurable dementia risk factors: 1.1. Systolic blood pressure measured twice with a calibrated automated blood pressure device 1.2. non-HDL cholesterol measured using a capillary blood sample 1.3. BMI (kg/m2) calculated using weight and height measured with a calibrated scale Implementation outcomes: Quantitative: 2.1. Coverage: (non)response rates, comparison characteristics participants with eligible/source population measured at baseline 2.2. Adoption: quantitative analysis of the utilisation, usage and uptake, e.g. logins, goals setting, sending messages measured after 1 month (data features) 2.3. Appropriateness measured using a short questionnaire of perceived fit or relevance after 6 months and at study end 2.4. Acceptability measured using a short questionnaire of agreeability, user-friendliness, credibility, complexity, content* after 6 months and at study end 2.5. Sustainability: adherence, dropout measured after 6 months and at the end of the study, data features throughout the study 2.6. Implementation cost estimated by platform price and coach full-time equivalent at the end of the study Qualitative: 2.7. Feasibility: the extent to which the mHealth intervention can be carried out, practical and social barriers/facilitators measured after 6 months 2.8. Appropriateness: perceived fit or relevance in the target population measured after 6 months 2.9. Acceptability: agreeability, user-friendliness, credibility, complexity, content measured after 6 months 2.10. Fidelity: the degree to which the mHealth application is implemented compared to the original protocol, measured after 6 months 2.11. Adoption: initial utilisation, usage and uptake measured after 6 months 2.12. Sustainability: adherence, dropout measured after 6 months _____ Previous primary outcome measure: All effectiveness outcomes are measured at baseline and at the study end after 12 months. 1. The primary effectiveness outcome will be a composite score of the objectively measurable dementia risk factors: 1.1. Systolic blood pressure measured twice with a calibrated automated blood pressure device 1.2. Total cholesterol measured using a capillary blood sample 1.3. BMI (kg/m2) calculated using weight and height measured with a calibrated scale Implementation outcomes: Quantitative: 2.1. Coverage: (non)response rates, comparison characteristics participants with eligible/source population measured at baseline 2.2. Adoption: quantitative analysis of the utilisation, usage and uptake, e.g. logins, goals setting, sending messages measured after 1 month (data features) 2.3. Appropriateness measured using a short questionnaire of perceived fit or relevance after 6 months and at study end 2.4. Acceptability measured using a short questionnaire of agreeability, user-friendliness, credibility, complexity, content* after 6 months and at study end 2.5. Sustainability: adherence, dropout measured after 6 months and at the end of the study, data features throughout the study 2.6. Implementation cost estimated by platform price and coach full-time equivalent at the end of the study Qualitative: 2.7. Feasibility: the extent to which the mHealth intervention can be carried out, practical and social barriers/facilitators measured after 6 months 2.8. Appropriateness: perceived fit or relevance in the target population measured after 6 months 2.9. Acceptability: agreeability, user-friendliness, credibility, complexity, content measured after 6 months 2.10. Fidelity: the degree to which the mHealth application is implemented compared to the original protocol, measured after 6 months 2.11. Adoption: initial utilisation, usage and uptake measured after 6 months 2.12. Sustainability: adherence, dropout measured after 6 months |
| Secondary outcome measures | Current secondary outcome measures as of 05/06/2024: All effectiveness outcomes are measured at baseline and at study end after 12 months: 1. Physical exercise measured using the self-administered short International Physical Activity Questionnaire - Short Form (IPAQ-SF) 2. Disability measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item) 3. Depressive symptoms measured using the Geriatric Depression Scale 15-item (GDS-15) 5. Dementia risk score measured using Cardiovascular Risk Factors, Aging and Dementia (CAIDE) 6. Individual modifiable components of the CAIDE risk score 7. Intervention costs measured using costs of coaches and intervention development by Interactive Studios 8. Cost-effectiveness analyses using health-economic decision-analytic model 9. Cognitive functioning measured using the Rowland Universal Dementia Assessment Scale (RUDAS) and Box task 10. Daily distance moved, measured usingBehapp, a remote behavioural monitoring app, in a subgroup of participants willing to install the BeHapp app _____ Previous secondary outcome measures: All effectiveness outcomes are measured at baseline and at study end after 12 months: 1. Physical exercise measured using the self-administered short International Physical Activity Questionnaire - Short Form (IPAQ-SF) 2. Disability measured using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item) 3. Depressive symptoms measured using the Geriatric Depression Scale 15-item (GDS-15) 5. Dementia risk score measured using Cardiovascular Risk Factors, Aging and Dementia (CAIDE) 6. Individual modifiable components of the CAIDE risk score 7. Intervention costs measured using costs of coaches and intervention development by Interactive Studios 8. Cost-effectiveness analyses using health-economic decision-analytic model 9. Cognitive functioning measured using the Rowland Universal Dementia Assessment Scale (RUDAS) 10. Daily distance moved, measured usingBehapp, a remote behavioural monitoring app, in a subgroup of participants willing to install the BeHapp app |
| Overall study start date | 01/01/2023 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 692 |
| Key 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 _____ 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 |
| Key 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 |
| Date of first enrolment | 01/07/2024 |
| Date of final enrolment | 01/07/2025 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam UMC
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
Amsterdam
1105AZ
Netherlands
Sponsor information
Amsterdam University Medical Centers
Hospital/treatment centre
Hospital/treatment centre
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| info@amc.nl | |
| Website | https://www.amsterdamumc.org |
"ROR" |
https://ror.org/05grdyy37 |
Funders
Funder type
Government
ZonMw
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal and presentation at international conferences. |
| IPD sharing plan | The datasets generated during the current study will be available upon reasonable request in anonymised .csv format after publication of the main results for at least 5 years after publication. The request can be sent to the data manager, currently Dr M. Hoevenaar-Blom (m.p.hoevenaarblom@amsterdamumc.nl), upon which the study steering committee will judge the suitability of the data for the research question. In the informed consent form, explicit consent will be asked for future data use for research questions related to the original research question. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.1 | 30/05/2024 | 05/06/2024 | No | No |
| Statistical Analysis Plan | 05/06/2024 | 05/06/2024 | No | No | |
| Protocol file | 14/06/2024 | 19/06/2024 | No | No | |
| Statistical Analysis Plan | 14/06/2024 | 19/06/2024 | No | No | |
| Protocol article | 03/02/2025 | 04/02/2025 | Yes | No |
Additional files
Editorial Notes
04/02/2025: Publication reference added.
19/06/2024: The following changes were made:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
3. The interventions were changed.
05/06/2024: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
3. The ethics approval was added.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The inclusion criteria were changed.
7. The recruitment start date was changed from 01/06/2024 to 01/07/2024.
07/05/2024: The contact email was changed.
08/01/2024: Study's existence confirmed by ZonMw.
