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

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 Overview

• Status: Completed
• Conditions: We Are Not Studying a Disease or Condition; The Study is Focused on People With Limited Health Literacy
• Intervention / Treatment: Behavioral: Gezond en goed met elkaar

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Vrije Universiteit Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention 'Gezond en goed met elkaar'; see description of the intervention 'Gezond en goed met elkaar'	Behavioral: Gezond en goed met elkaar; 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.
No Intervention: Control group; 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.
No Intervention: Control group 2; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline measurement to 9 months later
Basic Psychological Needs	BPNSFS-ID: Basic Psychological Needs Satisfaction and Frustration Scale	From baseline measurement to 9 months later
Well-Being	ASCOT: The Adult Social Care Outcomes Toolkit - dutch translation	From baseline measurement to 9 months later
Quality of Life (QALYs)	EQ-5D-5L: 5-level EQ-5D version (EuroQol Group, 2009)	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	From baseline measurement to 9 months later

Collaborators and Investigators

• Sponsor: VU University of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2024
• Primary Completion (Actual): August 18, 2025
• Study Completion (Actual): August 18, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: intervention; health literacy; positive health; Gezond en goed met elkaar
• Other Study ID Numbers: 2024.0213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No