← Back to all trials
Not Yet Recruiting
NCT05694351
Family-based Prevention of Diabetes Through Eating Habits and Physical Activity
Conditions: Diabetes Mellitus, Type 2, Family Health, Health Behavior, Healthy Lifestyle, Prediabetic State, Telemedicine
Sex: All
Ages: 5 Years – 99 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Slagelse Hospital
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.
Eligibility Criteria
Inclusion Criteria:Parents (aged 18 or older) with (or at risk of) type 2 diabetes living in the same household with 5-17 years old childrenAt least one family member not meeting the current physical activity recommendations.Exclusion Criteria:Pregnancy or postpartum period (6 months after birth)Current critical illness, e.g.
cancerParticipating in other type 2 diabetes treatment programs
Source: ClinicalTrials.gov (NCT05694351). StuddyBuddy aggregates publicly available trial information.