Individualized Non-pharmacological Intervention for Bowel Preparation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Preparation for Colonoscopy
• Intervention / Treatment: Other: Standard bowel preparation guidance; Other: Individualized bowel preparation regimen; Other: Information-framing guidance

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 339
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingshun Qi; Phone Number: +8618909881019; Email: xingshunqi@126.com
• Study Contact Backup: Name: weiyi wang; Phone Number: 13019441021; Email: 373302698@qq.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • Recruiting
      • General Hospital of Northern Theater Command
      • Contact: Xingshun Qi; Phone Number: 13019441024; Email: xingshunqi@126.com
      • Contact: Email: 373302698@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age ≥ 18 years;
• outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
• able to understand the study and provide written informed consent.

Exclusion Criteria:

• undergoing emergency colonoscopy;
• suspected intestinal obstruction, stricture, or perforation;
• severe cardiac, cerebral, hepatic, or renal disease;
• severe psychiatric disorder;
• impaired consciousness or communication difficulties;
• pregnancy or lactation;
• previous enrollment in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard bowel preparation group; Patients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen.	Other: Standard bowel preparation guidance; Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.
Experimental: Individualized bowel preparation group; Patients receive verbal instructions and printed illustrated bowel preparation educational materials. The inadequate bowel preparation risk score is calculated using the established prediction model. Patients with a risk score ≥ 3.25 receive an enhanced bowel preparation regimen, whereas those with a score < 3.25 receive the standard bowel preparation regimen. The enhanced bowel preparation regimen is based on the standard protocol, with two additional components. First, starting 3 days before the colonoscopy, patients are instructed to avoid high-fiber foods and, from 1 day before the colonoscopy, to adopt a semiliquid low-residue diet. They are also asked to walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day. Second, after consuming each 500 mL of the polyethylene glycol electrolyte solution and upon finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes.	Other: Individualized bowel preparation regimen; 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.
Experimental: Information-framing guided individualized bowel preparation group; Patients receive the same interventions as those in the individualized group. In addition, they receive information-framed educationa material. 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.	Other: Individualized bowel preparation regimen; 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.; Other: Information-framing guidance; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel preparation quality	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.	Assessed by the endoscopist during colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bowel preparation-related adverse events	Incidence of nausea, vomiting, abdominal distension, abdominal pain	Recorded during the waiting period prior to colonoscopy procedure
Polyp/adenoma detection rate		Assessed by the endoscopist during colonoscopy procedure
Compliance of bowel preparation	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.	Assessed during the waiting period prior to colonoscopy procedure
Willingness to undergo colonoscopy again (yes/no)	Patients are asked whether they are willing to undergo a repeat colonoscopy.	Assessed during the waiting period prior to colonoscopy procedure

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Study Chair: Xingshun Qi, The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: colonoscopy; bowel praparation; individualized non-pharmacological intervention
• Other Study ID Numbers: XHNKKY-INPI-1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets analyzed during the current study are not publicly available due to ethical considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No