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OpenTrials
Completed

NCT Number: NCT06644547

(Cost)Effectiveness of the Intervention 'Gezond en Goed Met Elkaar'

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

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Key information

Conditions

The Study is Focused on People With Limited Health Literacy We Are Not Studying a Disease or Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vrije Universiteit Amsterdam

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older

Exclusion criteria

  • analfabetism
  • insufficient language level of Dutch to be able to participate in the intervention

Treatment and study plan

Gezond en goed met elkaar

Behavioral

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.

Primary outcomes

  1. 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

  2. Vitality

    Time frame: From baseline measurement to 9 months later

    SF-12 Vitality (VT) question 6b

Secondary outcomes

  1. Health Literacy

    Time frame: From baseline measurement to 9 months later

    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

  2. Basic Psychological Needs

    Time frame: From baseline measurement to 9 months later

    BPNSFS-ID: Basic Psychological Needs Satisfaction and Frustration Scale

  3. Well-Being

    Time frame: From baseline measurement to 9 months later

    ASCOT: The Adult Social Care Outcomes Toolkit - dutch translation

  4. Quality of Life (QALYs)

    Time frame: From baseline measurement to 9 months later

    EQ-5D-5L: 5-level EQ-5D version (EuroQol Group, 2009)

  5. Health Care and Productivity Costs

    Time frame: From baseline measurement to 9 months later

    Cost questionnaire developed by Health Sciences Department (Economic Evaluation) of VU University of Amsterdam

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Acronym: GGME

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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