NCT05694351Completed
Family-based Prevention of Diabetes Through Eating Habits and Physical Activity
GO EASY: Eating Habits and Physical Activity in Synergy for Diabetes Prevention in Families
Source: ClinicalTrials.gov · Last updated 18 May 2025
Brief summary (registry, in English)
Introduction: Type 2 diabetes represents a growing health risk for the society. An easy-access and low-cost intervention for the whole family will be developed to help families with (at risk of) type 2 diabetes maintain diabetes-frendly everyday life. The intervention will be tested for feasibility. Methods: Following the framework for developing and conduct of complex interventions, the intervention will be developed on the basis of current evidence on family-based diabetes treatment and opinions of families with type 2 diabetes. The feasibility test will have embedded mixed methods one-group study design. Participants: Families will answer a brief screening questionnaire. Families (n=25) that consist of at least one adult with (in risk of) type 2 diabetes living in the same household with at least one 5-18 yeard old child, and at least one family member living sedentary lifestyle, will participate. Intervention: The 3-months long hybrid telehealth/face-to-face intervention with weekly 1-hour contacts with health professionals will deliver diabetes education and tailored support to implement more physical activity and healthy meals in the family everyday life. A 3-months long supervised maintenance phase with monthly professional contacts will be included. Outcomes: Feasibility evaluation will be conducted using quantitative (quantifiable) and qualitative research methods. The feasibility data will be the primary outcomes of the study, collected and evaluated using the predefined research progression criteria applied the green-amber-red method. Sociodemography and secondary outcomes, such as physical activity, dieting habits, daily occupations, occupational balance, health and quality of life will be assessed at baseline and 3 and 6-months follow-ups. The quantitative results will be comprehended through qualitative data from participant interviews which will nuance the feasibility evaluation. Analysis: Relevant statistical methods and qualitative analysis method will be applied. Expected results: The intervention will help families achieve sustainable lifestyle changes, e.g., diabetes stabilized blood glucose in adults with type 2 diabetes, increased physical activity time and improved dieting habits, for better family health and well-being. Ethics and dissemination: The trial does not have any obvious health risks for the participants. All the results - significant, non-significant and/ or inconclusive - will be reported.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 29 Dec 2022
- Start date
- 15 Jan 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Slagelse Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT05694351
What you commit to
- Study type: Interventional
- Participants enrolled: 18
- From 15 Jan 2024 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current critical illness, e.g. cancer
- Participating in other type 2 diabetes treatment programs
Other
- Pregnancy or postpartum period (6 months after birth)
Who the study is looking for
- Parents (aged 18 or older) with (or at risk of) type 2 diabetes living in the same household with 5-17 years old children
- At least one family member not meeting the current physical activity recommendations.
Age in the registry: 5 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Svetlana Solgaard Nielsen Coordinator of this site? Confirm its status | Slagelse | Denmark | Unknown status |
Related publications
- Enhancing personal capacities in families with or at risk of type 2 diabetes: qualitative investigation of the GO EASY intervention.BMC Public Health · 2026 · PMID 41826886
This page is information, not medical advice. Discuss any trial with your doctor.