Efficacy of the Proactive Automatized Lifestyle Intervention

Официальное название

Investigating the Efficacy of the Proactive Automatized Lifestyle Intervention Among General Hospital Patients

Обзор

Background: Individual brief behavior change interventions often do not sufficiently address the common co-occurrence of multiple health risk behaviors among people. In addition, many interventions often fail to reach the majority of the target population and particularly those people who need them the most. To address these core challenges of individual prevention research, the "Proactive Automatised Lifestyle intervention (PAL)" was developed, a proactive screening and brief intervention driven by psychological health behavior change theory to motivate participants for behavior change. The trial ePAL aims to investigate the efficacy of the multi-behavior change intervention adressing tobacco smoking, alcohol use, diet and physical activity among general hospital patients over 2 years; and to investigate differential efficacy in different subgroups of patients. Methods: All patients admitted to non-intensive care wards on five medical departments within the University Medicine Hospital Greifswald (internal medicine A \& B, surgery, trauma surgery, ear-nose-throat) and aged 18 to 64 years are systematically approached by study assistants and asked to first participate in a survey and then in the randomizd controlled trial, irrespective of their reason of admission. A total of 788 participants is allocated to two study groups. The intervention group receives individualized feedback on all four health risk behaviors to enhance motivation to change identified health risk behaviors. The feedback is driven by psychological behavior change theory, tailored to the participants' current stages of change and delivered after baseline and at months 1 and 3. The control group receives routine care and minimal assessment only. Follow-ups are conducted at months 6, 12 and 24 after baseline; and more are planned for. Efficacy will be measured concerning self-reported change in health risk behaviors, health and motivation to change measures using latent growth curve modelling. Discussion: The trial will provide information on the efficacy of a population-based and individually tailored brief intervention to systematically provide individualized feedback to each patient for a healthy living. When found to be effective and implemented widely, such interventions may contribute to the prevention of widespread non-communicable diseases.

Вмешательства

• Поведенческое Proactive Automatized Lifestyle intervention
  addresses tobacco smoking, alcohol use, unhealthy diet and insufficient physical activity, individually-tailored, theory-driven, repetitive with three intervention contacts, normative and ipsative feedback, online feedback.

Первичные конечные точки

• Difference in Multiple Health Risk Behavior Index [Срок оценки: month 0, 1, 3, 6, 12, 24]
• Difference in physical activity [Срок оценки: months 0, 1, 3, 6, 12, 24]
• Difference in diet [Срок оценки: months 0, 1, 3, 6, 12, 24]
• Difference in alcohol use [Срок оценки: months 0, 1, 3, 6, 12, 24]
• Difference in tobacco smoking [Срок оценки: months 0, 1, 3, 6, 12, 24]

Вторичные конечные точки (12)

• Difference in stage of change [Срок оценки: months 0, 1, 3, 6, 12, 24]
• Difference in self-efficacy [Срок оценки: months 0, 1, 3, 6, 12, 24]
• Difference in decisional balance [Срок оценки: months 0, 1, 3, 6, 12, 24]
• Difference in processes of change [Срок оценки: months 0, 1, 3, 6, 12, 24]
• Difference in general health [Срок оценки: month 0, 6, 12, 24]
• Difference in mental health [Срок оценки: months 0, 6, 12, 24]
• Difference in sick days [Срок оценки: months 0, 6, 12, 24]
• Difference in non-communicable diseases [Срок оценки: months 0, 6, 12, 24]
• Difference in utilization of health care - general practitioner [Срок оценки: months 0, 6, 12, 14]
• Difference in utilization of health care - medical specialist [Срок оценки: months 0, 6, 12, 24]
• Difference in utilization of health care - physiotherapist [Срок оценки: months 0, 6, 12, 24]
• Difference in utilization of health care - psychologist/ psychotherapist/ psychiatrist [Срок оценки: months 0, 6, 12, 24]

Критерии участия

Критерии включения

• Admitted to participating wards of the University Medicine Hospital Greifswald on Mondays through Thursdays

Критерии исключения

• cognitively or physically incapable
• presence of a highly infectious disease
• discharged or transferred within the first 24 hours
• already recruited for study during previous stay
• insufficient German language skills
• employed the conducting research department
• accompanying persons
• no email address (and no phone number)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Германия · 1 центр

• University Medicine Hospital Greifswald — Greifswald

Идентификаторы

NCT: NCT07441603 · D8 4700 0010 · 70115790

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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