Clinical Research Directory

Efficacy of the Proactive Automatized Lifestyle Intervention

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.

A BCT Intervention for Physical Activity Among Individuals on Statins

The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of physical activity (PA) among participants on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Participants will complete a 2-week baseline run-in period where PA levels will be measured using Fitbit wearable device. Then 42 participants will be randomized into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose. Assignment to doses will utilize a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) methodology to adjust the dose for each cohort based on the results from the previous cohort. After the intervention, there will be a 2-week follow-up period. The MED will be defined as the smallest BCT dose (defined by weeks of intervention) associated with 80% of participants having a successful PA increase between the run-in and the follow-up periods (defined as walking an extra 2,000 more steps per day).

Effectiveness of Interventions to Promote Physical Activity During Pregnancy

Pregnant women are more sedentary (sit, recline, lie down more) on average than non-pregnant women (more than 12 versus less than 8 waking sedentary hours/day). Sedentary behavior has been related to psychological distress, pregnancy weight gain, impaired sleep and very large size infants, while adequate physical activity has been found to improve mental health, decrease risk of high blood pressure in pregnancy and lower risk of preterm birth infants (less than 37 weeks gestation). Decreased sedentary behavior and increased physical activity may be crucial and neglected lifestyle behavior changes that can be promoted to reduce these and other maternal health and birth outcome problems among pregnant women.