At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
GO EASY: Eating Habits and Physical Activity in Synergy for Diabetes Prevention in Families
In Brief
A clinical study evaluating Healthy meals and physical activity in families with type 2 diabetes for Diabetes Mellitus, Type 2 and 5 related conditions. Completed, enrolled 18 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Families will participate in telehealth family education on diabetes management and prevention through lifestyle modifications in their everyday occupations regarding current recommendations for physical activity, grocery shopping, meal preparation, and family meal routines. Each family will be assisted in setting tailored goals for the family as a whole and individually regarding physical activity and dieting habits. The goals will be incorporated into family daily routines, to secure manageability and sustainability of the new lifestyle habits. Local facilities and communy networks will be engaged in this process to empower and motivate the participants. Working with the goals will be monitored and facilitated throughout the intervention period of 3 months. Before discharge, each family will co-produce a maintenance plan for physical activity and healthy dieting.