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NCT Number: NCT07684716

Individualized Non-pharmacological Intervention for Bowel Preparation

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized bowel preparation regimen

Other

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.

Information-framing guidance

Other

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.

Standard bowel preparation guidance

Other

Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.

Primary outcomes

  1. Bowel preparation quality

    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.

Secondary outcomes

  1. Incidence of bowel preparation-related adverse events

    Time frame: Recorded during the waiting period prior to colonoscopy procedure

    Incidence of nausea, vomiting, abdominal distension, abdominal pain

  2. Polyp/adenoma detection rate

    Time frame: Assessed by the endoscopist during colonoscopy procedure

  3. Compliance of bowel preparation

    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.

  4. Willingness to undergo colonoscopy again (yes/no)

    Time frame: Assessed during the waiting period prior to colonoscopy procedure

    Patients are asked whether they are willing to undergo a repeat colonoscopy.

Study contacts

Contact information is provided by the study sponsor or research team.

Xingshun Qi

CONTACT

[email protected]

+8618909881019

weiyi wang

CONTACT

[email protected]

13019441021

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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