Bowel Preparation for ColonoscopyNCT07684716
Individualized Non-pharmacological Intervention for Bowel Preparation
A study testing Individualized bowel preparation regimen, Information-framing guidance and Standard bowel preparation guidance in people with Bowel Preparation for Colonoscopy, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Individualized bowel preparation regimen, Information-framing guidance and Standard bowel preparation guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years;
- outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
- able to understand the study and provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Xingshun Qi, 13019441024, xingshunqi@126.com
373302698@qq.com
About this study
Official 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
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.
Read the 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.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Individualized bowel preparation regimen, Information-framing guidance, Standard bowel preparation guidance
- Keywords
- colonoscopy, bowel praparation, individualized non-pharmacological intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized bowel preparation regimenOther
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 guidanceOther
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 guidanceOther
Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.
| Study group | Role | What they receive |
|---|---|---|
| Standard bowel preparation group | Active comparator | Patients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen. Receives: Other: Standard bowel preparation guidance |
| Individualized bowel preparation group | Experimental | 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. Receives: Other: Individualized bowel preparation regimen |
| Information-framing guided individualized bowel preparation group | Experimental | 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. Receives: Other: Individualized bowel preparation regimen; Other: Information-framing guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed by the endoscopist during colonoscopy procedure
Secondary outcomes (4)
Incidence of bowel preparation-related adverse events
Incidence of nausea, vomiting, abdominal distension, abdominal pain
Measured: Recorded during the waiting period prior to colonoscopy procedure
Polyp/adenoma detection rate
Measured: 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.
Measured: 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.
Measured: Assessed during the waiting period prior to colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start8 Jun 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, Study chair, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684716
- Sponsor's protocol ID
- XHNKKY-INPI-1.0
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets analyzed during the current study are not publicly available due to ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07684716
- Acronym / sponsor ID
- XHNKKY-INPI-1.0
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- colonoscopy, bowel praparation, individualized non-pharmacological intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard bowel preparation group | Active comparator | Other: Standard bowel preparation guidancePatients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen. |
| Individualized bowel preparation group | Experimental | Other: Individualized bowel preparation regimenPatients 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. |
| Information-framing guided individualized bowel preparation group | Experimental | Other: Individualized bowel preparation regimen, Other: Information-framing guidancePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years;
- outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
- able to understand the study and provide written informed consent.
Key exclusion criteria (7 listed)
- undergoing emergency colonoscopy;
- suspected intestinal obstruction, stricture, or perforation;
- severe cardiac, cerebral, hepatic, or renal disease;
- severe psychiatric disorder;
- impaired consciousness or communication difficulties;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized bowel preparation regimenPatients 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 | Individualized bowel preparation group, Information-framing guided individualized bowel preparation group |
| Information-framing guidanceFor 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 | Information-framing guided individualized bowel preparation group |
| Standard bowel preparation guidancePatients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials. | Other | Standard bowel preparation group |
Primary outcome
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.
4 secondary outcomes
Incidence of bowel preparation-related adverse events
Time frame: Recorded during the waiting period prior to colonoscopy procedure
Polyp/adenoma detection rate
Time frame: Assessed by the endoscopist during colonoscopy procedure
Compliance of bowel preparation
Time frame: Assessed during the waiting period prior to colonoscopy procedure
Willingness to undergo colonoscopy again (yes/no)
Time frame: Assessed during the waiting period prior to colonoscopy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. The datasets analyzed during the current study are not publicly available due to ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingshun Qi study chair
The General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized bowel preparation regimen, Information-framing guidance and Standard bowel preparation guidance in people with Bowel Preparation for Colonoscopy, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingshun Qi (+8618909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation quality (time frame: Assessed by the endoscopist during colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.