NCT06644547

Brief 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 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

October 11, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

health literacypositive healthinterventionGezond en goed met elkaar

Outcome Measures

Primary Outcomes (2)

  • Positive Health

    Positive Health questionnaire developed by Institute of Positive Health (iPH) 17 items, answered on a 10-point Likert scale

    From baseline measurement to 9 months later

  • Vitality

    SF-12 Vitality (VT) question 6b

    From baseline measurement to 9 months later

Secondary Outcomes (5)

  • Health Literacy

    From baseline measurement to 9 months later

  • Basic Psychological Needs

    From baseline measurement to 9 months later

  • Well-Being

    From baseline measurement to 9 months later

  • Quality of Life (QALYs)

    From baseline measurement to 9 months later

  • Health Care and Productivity Costs

    From baseline measurement to 9 months later

Study Arms (3)

Intervention 'Gezond en goed met elkaar'

EXPERIMENTAL

see description of the intervention 'Gezond en goed met elkaar'

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.

Interventions

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.

Intervention 'Gezond en goed met elkaar'

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, Netherlands

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Pragmatic stepped-wedge design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 16, 2024

Study Start

June 26, 2024

Primary Completion

August 18, 2025

Study Completion

August 18, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations