Evaluating the effectiveness of lifestyle education for individuals at increased risk of type 2 diabetes and cardiovascular diseases (Halt2Diabetes): protocol for a repeated measures study

评估生活方式教育对2型糖尿病和心血管疾病高危人群的有效性(Halt2Diabetes):一项重复测量研究方案

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Abstract

BACKGROUND: Halt2Diabetes is a prevention initiative in Flanders, Belgium, targeting the rising prevalence of type 2 diabetes (T2D) and cardiovascular diseases (CVDs). The program uses a two-step approach to identify high-risk individuals and guide them towards healthier lifestyles, reducing T2D and CVD risk factors. Building on evidence that lifestyle interventions can prevent both conditions by addressing modifiable risk factors, this research evaluates the effectiveness of Halt2Diabetes as a scalable real-world intervention and its potential as a blueprint for other contexts. METHODS: The Halt2Diabetes program identifies high-risk individuals using the Finnish Diabetes Risk Score (FINDRISC) through an online risk assessment tool. Eligible participants, referred by general practitioners, participate in six group-based lifestyle guidance sessions led by trained dietitians, focusing on healthy eating, physical activity, and behavior modification. This longitudinal study employs repeated measurements at five time points over 18 months. Primary outcomes include changes in body weight, waist circumference, and hemoglobin A1c (HbA1c) levels. Secondary outcomes encompass blood pressure, cholesterol levels, physical activity, and dietary habits. Data collection involves self-reported questionnaires, biochemical measures, and anthropometric assessments. Analysis will examine longitudinal changes in health and behavioral outcomes among participants. DISCUSSION: This study will provide evidence for the real-world effectiveness of Halt2Diabetes in promoting sustained lifestyle changes and reducing T2D and CVD risk factors. Despite challenges including participation barriers and data integration needs, the program's scalable, digitalized risk assessment model shows promise for broader application. The findings will enhance understanding of effective T2D and CVD prevention strategies, offering insights for policymakers and healthcare providers to strengthen public health initiatives. TRIAL REGISTRATION: This study is registered with the ISRCTN registry, identifier: ISRCTN62149214 ( https://www.isrctn.com/ISRCTN62149214 ). The date of registration is March 13, 2025.

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