General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016, China
Location status: Recruiting
NCT Number: NCT07684716
Colonoscopy is essential for the early detection of colorectal cancer. However, inadequate bowel preparation remains a common challenge, associated with reduced adenoma detection rates, prolonged procedure time, and increased healthcare costs. Current individualized regimens rely largely on higher laxative dosages-an approach with limited clinical utility. Non-pharmacological interventions, including dietary modification, physical activity, and health education, are safe and tend to have better patient adherence. The effectiveness of health education depends largely on message framing. Guided by information-framing theory, we developed an individualized non-pharmacological regimen. This randomized controlled trial aims to evaluate the efficacy of this regimen in improving bowel preparation quality.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Shenyang, Liaoning, 110016, China
Location status: Recruiting
A total of 339 patients are enrolled and randomly assigned in a 1:1:1 ratio to the information-framing + individualized bowel preparation (BP) group, the individualized BP group, and the control group. All patients receive oral instructions on bowel preparation. On this basis, the control group receives a standard BP regimen and written educational materials; the individualized BP group is assessed using a risk prediction model for inadequate bowel preparation, with the results disclosed to the patients. Those with a risk score ≥3.25 receive an enhanced BP regimen, while those with a risk score <3.25 receive the standard BP regimen, and all patients in this group receive illustrated educational materials. In the information-framing + individualized BP group, educational materials are further tailored according to the information framework theory. Specifically, patients with a risk score ≥3.25 receive loss-framed materials emphasizing the harms of non-adherence, whereas those with a score <3.25 receive gain-framed materials highlighting the benefits of adherence. On the day of the colonoscopy, patients' willingness to undergo a repeat colonoscopy and the occurrence of adverse events are recorded in the waiting area. Patients also complete the Bowel Preparation Adherence Behavior Assessment Scale and the Treatment Self-Regulation Questionnaire. Bowel preparation quality is evaluated by endoscopists blinded to group allocation using the Boston Bowel Preparation Scale (BBPS), and polyp/adenoma detection rates are also recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients receive verbal instructions and printed illustrated bowel preparation educational material. Patients with a risk score ≥ 3.25 are instructed to take low-residue diet 3 days before colonoscopy and walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day. After consuming each 500 mL of polyethylene glycol electrolyte solution, and finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes. Patients with a score < 3.25 received the standard bowel preparation regimen.
For those with an inadequate bowel preparation risk score ≥ 3.25, negatively-framed materials emphasizing the harms of non-adherence are provided; for those with a score < 3.25, positively-framed materials emphasizing the benefits of adherence are provided.
Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.
Time frame: Assessed by the endoscopist during colonoscopy procedure
Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (BBPS). Bowel preparation was considered adequate when the total BBPS score was ≥ 6, with each colonic segment score ≥ 2.
Time frame: Recorded during the waiting period prior to colonoscopy procedure
Incidence of nausea, vomiting, abdominal distension, abdominal pain
Time frame: Assessed by the endoscopist during colonoscopy procedure
Time frame: Assessed during the waiting period prior to colonoscopy procedure
Compliance of bowel preparation is assessed by Bowel Preparation Adherence Behavior Assessment Scale. The Bowel Preparation Adherence Behavior Assessment Scale has a total score ranging from 12 to 60, with higher scores indicating better adherence.
Time frame: Assessed during the waiting period prior to colonoscopy procedure
Patients are asked whether they are willing to undergo a repeat colonoscopy.
Contact information is provided by the study sponsor or research team.
Xingshun Qi
CONTACT
weiyi wang
CONTACT
General Hospital of Shenyang Military Region
Other
Effect of an Individualized Non-pharmacological Intervention Based on a Predictive Model for Inadequate Bowel Preparation on Bowel Preparation Quality: a Three-arm, Prospective, Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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