The Study is Focused on People With Limited Health LiteracyGGMENCT06644547
(Cost)Effectiveness of the Intervention 'Gezond en Goed Met Elkaar'
A study testing Gezond en goed met elkaar in people with The Study is Focused on People With Limited Health Literacy and We Are Not Studying a Disease or Condition, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
The goal of this intervention study is to learn if the intervention can increase positive health and health literacy in people with limited health literacy. The main questions it aims to answer are: Does participating in the intervention 'Gezond en goed met elkaar' increase participant's positive health? Does… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Study is Focused on People With Limited Health Literacy, We Are Not Studying a Disease or Condition
- What is being tested?
- Gezond en goed met elkaar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jun 2024to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
Who cannot join
- analfabetism
- insufficient language level of Dutch to be able to participate in the intervention
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this intervention study is to learn if the intervention can increase positive health and health literacy in people with limited health literacy. The main questions it aims to answer are:
- Does participating in the intervention 'Gezond en goed met elkaar' increase participant's positive health?
- Does participating in the intervention 'Gezond en goed met elkaar' improve health literacy?
Researchers will compare people who participate in the intervention with people who haven't participated in the intervention yet.
Participants will:
- participate in the intervention (3 months)
- fill out questionnaires every 3 months
- Conditions
- The Study is Focused on People With Limited Health Literacy, We Are Not Studying a Disease or Condition
- Being tested
- Gezond en goed met elkaar
- Keywords
- health literacy, positive health, intervention, Gezond en goed met elkaar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gezond en goed met elkaarBehavioural
The intervention 'Gezond en goed met elkaar' focuses on improving (positive) health literacy and literacy. The six domains of "positive health" are the focus of the intervention meetings. This intervention has been made available for citizens of Almere, Zwolle, Gouda, Nunspeet and Leusden through collaboration with these municipalities. Lifestyle coaches working in these municipalities implement the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 'Gezond en goed met elkaar' | Experimental | see description of the intervention 'Gezond en goed met elkaar' Receives: Behavioral: Gezond en goed met elkaar |
| Control group | No intervention | Participants do not receive the intervention yet. They have to wait 3 months before they start with the intervention. They will fill out questionnaires at baseline, 3, 6 and 9 months. |
| Control group 2 | No intervention | Participants do not receive the intervention yet. They have to wait 6 months before they start with the intervention. They will fill out questionnaires at baseline, 3, 6 and 9 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Health
Positive Health questionnaire developed by Institute of Positive Health (iPH) 17 items, answered on a 10-point Likert scale
Measured: From baseline measurement to 9 months later
Vitality
SF-12 Vitality (VT) question 6b
Measured: From baseline measurement to 9 months later
Secondary outcomes (5)
Health Literacy
HLS-EU-Q16 adapted to B1 language level For the psychometric analyses of HLS-EU-Q16, each of the 16 questions were coded according to the following: 'very difficult'=1 point, 'fairly difficult'=2 points, 'fairly easy'=3 points or 'very easy'=4 points, giving a total of 16-64 scores. The HLS-EU-Q16 manual recommends dichotomizing the answers from HLS-EU-Q16 ('very difficult'/'fairly difficult'=0, 'fairly easy'/'very easy'=1; total 0-16 scores)
1 \& 2 -> 0 3 \& 4 -> 1
dividing the total scores into three categories of HL: 0-8 = inadequate 9-12 = problematic 13-16 = adequate
Measured: From baseline measurement to 9 months later
Basic Psychological Needs
BPNSFS-ID: Basic Psychological Needs Satisfaction and Frustration Scale
Measured: From baseline measurement to 9 months later
Well-Being
ASCOT: The Adult Social Care Outcomes Toolkit - dutch translation
Measured: From baseline measurement to 9 months later
Quality of Life (QALYs)
EQ-5D-5L: 5-level EQ-5D version (EuroQol Group, 2009)
Measured: From baseline measurement to 9 months later
Health Care and Productivity Costs
Cost questionnaire developed by Health Sciences Department (Economic Evaluation) of VU University of Amsterdam
Measured: From baseline measurement to 9 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start26 Jun 2024
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Study is Focused on People With Limited Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pragmatic stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iris Koelmans, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644547
- Sponsor's protocol ID
- 2024.0213
- Acronym
- GGME
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Cost)Effectiveness of the Intervention 'Gezond en Goed Met Elkaar'
- ClinicalTrials.gov ID
- NCT06644547
- Acronym / sponsor ID
- GGME / 2024.0213
- Conditions
- The Study is Focused on People With Limited Health Literacy, We Are Not Studying a Disease or Condition
- Keywords
- health literacy, positive health, intervention, Gezond en goed met elkaar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this intervention study is to learn if the intervention can increase positive health and health literacy in people with limited health literacy. The main questions it aims to answer are:
- Does participating in the intervention 'Gezond en goed met elkaar' increase participant's positive health?
- Does participating in the intervention 'Gezond en goed met elkaar' improve health literacy?
Researchers will compare people who participate in the intervention with people who haven't participated in the intervention yet.
Participants will:
- participate in the intervention (3 months)
- fill out questionnaires every 3 months
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pragmatic stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Intervention 'Gezond en goed met elkaar' | Experimental | Behavioral: Gezond en goed met elkaarsee description of the intervention 'Gezond en goed met elkaar' |
| Control group | No intervention | –Participants do not receive the intervention yet. They have to wait 3 months before they start with the intervention. They will fill out questionnaires at baseline, 3, 6 and 9 months. |
| Control group 2 | No intervention | –Participants do not receive the intervention yet. They have to wait 6 months before they start with the intervention. They will fill out questionnaires at baseline, 3, 6 and 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older
Key exclusion criteria (2 listed)
- analfabetism
- insufficient language level of Dutch to be able to participate in the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gezond en goed met elkaarThe intervention 'Gezond en goed met elkaar' focuses on improving (positive) health literacy and literacy. The six domains of "positive health" are the focus of the intervention meetings. This intervention has been made available for citizens of Almere, Zwolle, Gouda, Nunspeet and Leusden through collaboration with these municipalities. Lifestyle coaches working in these municipalities implement the intervention. | Behavioural | Intervention 'Gezond en goed met elkaar' |
Primary outcome
Positive Health
Time frame: From baseline measurement to 9 months later
Positive Health questionnaire developed by Institute of Positive Health (iPH) 17 items, answered on a 10-point Likert scale
Vitality
Time frame: From baseline measurement to 9 months later
SF-12 Vitality (VT) question 6b
5 secondary outcomes
Health Literacy
Time frame: From baseline measurement to 9 months later
Basic Psychological Needs
Time frame: From baseline measurement to 9 months later
Well-Being
Time frame: From baseline measurement to 9 months later
Quality of Life (QALYs)
Time frame: From baseline measurement to 9 months later
Health Care and Productivity Costs
Time frame: From baseline measurement to 9 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gezond en goed met elkaar in people with The Study is Focused on People With Limited Health Literacy and We Are Not Studying a Disease or Condition, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Health (time frame: From baseline measurement to 9 months later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.