Randomized study designs for lifestyle interventions: a tutorial.
John O Younge, Tessa A Kouwenhoven-Pasmooij, Rosanne Freak-Poli...
https://pubmed.ncbi.nlm.nih.gov/26377509/Actively Recruiting
Led by University of Pecs · Updated on 2023-04-26
364
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating whether stopping alcohol consumption and smoking can prevent the recurrence of acute pancreatitis, a condition often worsened by these habits. This combined study includes a randomized controlled trial and a cohort study to assess the effectiveness of lifestyle changes in reducing repeated episodes of acute pancreatitis and related health outcomes. The study focuses on patients who are daily smokers hospitalized with alcohol-induced pancreatitis and aims to clarify the impact of quitting alcohol and tobacco. Participants will receive either a standard intervention or a standard intervention plus repeated intervention. The standard intervention involves a 30-minute counseling session based on WHO guidelines, delivered by trained nurses, including education about acute pancreatitis. The repeated intervention adds ongoing personalized counseling every three months, with feedback based on laboratory tests like mean corpuscular volume and gamma glutamyl-transferase to support motivation. The study monitors participants over two years to evaluate recurrence rates and mortality. During the study, patients will attend visits every three months or yearly depending on their assigned group. At each visit, researchers will assess addiction, motivation, quality of life, and socioeconomic status, and collect laboratory samples including blood, urine, and hair for biomarker analysis. Outcomes measured include recurrence of pancreatitis, hospital visits, development of chronic pancreatitis, healthcare costs, and alcohol and tobacco use changes. The study also evaluates cost-effectiveness and monitors safety throughout the 24-month period.
CONDITIONS
Preventing the Recurrence of Acute Pancreatitis by Alcohol and Smoking Cessation
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Pecs
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive a standard intervention to support cessation of alcohol and smoking. Those in the repeated intervention arm receive additional tailored sessions every 3 months with feedback based on laboratory testing.
Visits every 3 months or yearly depending on random allocation
Duration - Up to 24 months
Participants are monitored for recurrence of acute pancreatitis, changes in alcohol and tobacco use, quality of life, and healthcare outcomes for up to 24 months.
Assessments at 3, 6, 9, 12, 15, 18, 21, and 24 months
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
John O Younge, Tessa A Kouwenhoven-Pasmooij, Rosanne Freak-Poli...
https://pubmed.ncbi.nlm.nih.gov/26377509/Isto Nordback, Hanna Pelli, Riitta Lappalainen-Lehto...
https://pubmed.ncbi.nlm.nih.gov/19162029/Janne Schurmann Tolstrup, Louise Kristiansen, Ulrik Becker...
https://pubmed.ncbi.nlm.nih.gov/19307524/O Sadr-Azodi, Å Andrén-Sandberg, N Orsini...
https://pubmed.ncbi.nlm.nih.gov/21836026/Somashekar G Krishna, Amrit K Kamboj, Phil A Hart...
https://pubmed.ncbi.nlm.nih.gov/28196021/Lisa M Fucito, Tess H Hanrahan
https://pubmed.ncbi.nlm.nih.gov/26297324/Scott Tenner, John Baillie, John DeWitt...
https://pubmed.ncbi.nlm.nih.gov/23896955/Marc A Schuckit
https://pubmed.ncbi.nlm.nih.gov/19168210/Eileen Fs Kaner, Fiona R Beyer, Colin Muirhead...
https://pubmed.ncbi.nlm.nih.gov/29476653/J Matthias Löhr, Enrique Dominguez-Munoz, Jonas Rosendahl...
https://pubmed.ncbi.nlm.nih.gov/28344786/University of Pecs
Lead Sponsor