Better ageing with personalized lifestyle support from a health coach using a digital app – a population-based intervention study in Germany
| ISRCTN | ISRCTN27323813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27323813 |
| Secondary identifying numbers | 24110 |
- Submission date
- 26/03/2025
- Registration date
- 12/06/2025
- Last edited
- 12/06/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English Summary
Background and study aims
Ageing is commonly associated with a decline in clinical and functional status and perceived well-being. This decline is associated with multi-morbidity, defined by the coexistence of two or more chronic disease conditions. Living with multi-morbidity impairs an individual’s quality of life, health span and lifespan.
The study aims are to assess the effect of a personalised, digitally delivered lifestyle intervention on clinical status (waist circumference), functional status (hand grip strength) and perceived well-being (WHO 5 well-being index) after 1 year. The study will also evaluate the effect of the lifestyle intervention on the onset and severity of multimorbidity and death after 3 years.
The KORA Digital-Fit study is part of the STAGE project. STAGE is a European Research and Innovation project studying healthy ageing and multi-morbidity using a life-course approach (https://stage-healthyageing.eu).
Who can participate?
Men and women aged 50-79 years from the population-based KORA cohort (Cooperative Health Research in the Region of Augsburg) who are part of the baseline surveys will be invited to participate.
What does the study involve?
Participants will be assigned to the intervention or standard of care group according to personal preference and eligibility. The digital intervention will provide personalised digital health coaching aimed at managing and preventing chronic conditions like obesity, type 2 diabetes, and cardiovascular diseases. Both the intervention group and matched participants of the standard of care group will undergo an end-of-study assessment after 1 year, as well as a telephone interview after 3 years.
What are the possible benefits and risks of participating?
The intervention group will be informed about individual lifelong health. The findings are beneficial as they will be used to develop qualitative prevention concepts for the ageing population.
Where is the study run from?
KORA Study Center (Germany)
When is the study starting and how long is it expected to run for?
January 2024 to December 2029
Who is funding the study?
The KORA study was initiated and financed by the Helmholtz Zentrum München – German Research Center for Environmental Health, which is funded by the German Federal Ministry of Education and Research (BMBF) and by the State of Bavaria. Data collection in the KORA study is done in cooperation with the University Hospital of Augsburg. The KORA Digital-Fit study is part of the STAGE project. STAGE has received funding from the European Union’s Horizon Europe Research and Innovation Programme under grant agreement nº 101137146. UK participants in Horizon Europe Project STAGE are supported by UKRI grant numbers 10112787 (Beta Technology), 10099041 (University of Bristol) and 10109957 (Imperial College London).
Who is the main contact?
Prof. Dr Annette Peters, annette.peters@helmholtz-munich.de
Contact information
Public, Scientific
Helmholtz Zentrum München – Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
Ingolstädter Landstraße 1
Neuherberg
85764
Germany
 ORCID ID |
0000-0002-3387-5685 |
|---|---|
| Phone | +49 (0)89 3187 3859 |
| birgit.linkohr@helmholtz-munich.de |
Principal Investigator
Helmholtz Zentrum München – Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
Ingolstädter Landstraße 1
Neuherberg
85764
Germany
| ORCID ID |
0000-0001-6645-0985 |
|---|---|
| Phone | +49 (0)89 3187 4566 |
| annette.peters@helmholtz-munich.de |
Study information
| Study design | Single-center open-label two-armed parallel-group controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Life-course informed, digitally supported, person-centred intervention study for the prevention of ageing with multi-morbidity in the population-based KORA study, Germany |
| Study acronym | KORA Digital-Fit Study |
| Study hypothesis | The primary objective is to assess whether a personalized, digital delivered lifestyle intervention changes clinical status, functional status and perceived well-being after 1 year. |
| Ethics approval(s) |
Approved 09/03/2025, Ethics Committee of the Bavarian State Medical Association (Mühlbaurstraße 16, München, 81677, Germany; +49 (0)894147335; ethikkommission@blaek.de), ref: 24110 |
| Condition | Stay healthy through ageing and prevention of multimorbidity |
| Intervention | A digitally delivered lifestyle intervention based on coaching regarding a healthy lifestyle with the overarching aim of ameliorating waist circumference, increasing muscle strength and perceived well-being over 1 year compared to standard of care. Participants will be assigned to the intervention or standard of care group according to personal preference and eligibility. The digital intervention will provide personalised digital health coaching aimed at managing and preventing chronic conditions like obesity, type 2 diabetes and cardiovascular diseases. Both the intervention group and matched participants of the standard of care group will undergo an end-of-study assessment after 1 year, as well as a telephone interview after 3 years. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Waist circumference is measured using measuring tape at baseline and 1 year 2. Hand grip strength is measured using a hand dynamometer at baseline and 1 year 3. Well-being measured using the WHO-5 well-being index (self-report questionnaire) at baseline and 1 year |
| Secondary outcome measures | 1. Multi-morbidity is measured by self-report at 3 years 2. Mortality is measured from record data at 3 years |
| Overall study start date | 01/01/2024 |
| Overall study end date | 31/12/2029 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 79 Years |
| Sex | Both |
| Target number of participants | 3000 |
| Participant inclusion criteria | 1. Men and women aged 50-79 years from the KORA study 2. Informed consent for the planned study procedures For the intervention arm: 1. Informed consent for the intervention study 2. Digital literacy and compatible personal device |
| Participant exclusion criteria | Participants who report a pre-existing severe comorbidity and/or a medical condition associated with a life expectancy of less than 1 year |
| Recruitment start date | 01/01/2026 |
| Recruitment end date | 31/12/2026 |
Locations
Countries of recruitment
- Germany
Study participating centre
Augsburg
86153
Germany
Sponsor information
Research organisation
Deutsches Forschungszentrum für Gesundheit und Umwelt (GmbH)
Ingolstädter Landstraße 1
Neuherberg
85764
Germany
| Website | https://www.helmholtz-munich.de |
|---|---|
"ROR" |
https://ror.org/00cfam450 |
Funders
Funder type
Not defined
Private sector organisation / Research institutes and centers
- Alternative name(s)
- German Research Center for Environmental Health, Helmholtz Zentrum München
- Location
- Germany
No information available
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be shared within the STAGE project. It will be available upon request from Helmholtz Munich in 2030. |
Editorial Notes
26/03/2025: Study's existence confirmed by the Ethics Committee of the Bavarian State Medical Association.
