Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease

NCT ID: NCT06342011

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief Summary

For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients.

Detailed Description

This study aims to verify the intervention effect of AID on IBD patients, promote the promotion of AID model, and provide new ideas for the prevention and treatment strategies of IBD patients.

In this study, 66 IBD patients who met the inclusion criteria were divided into experimental group and control group by randomized controlled trial method. The experimental group was based on routine nursing measures, and the intervention group taught patients to take anti-inflammatory diet and use the anti-inflammatory diet mini-program developed by the researcher, daily anti-inflammatory diet, intervention time was 8 weeks, and observed the inflammatory indicators (white blood cells, neutrophils, erythrocyte precipitation, CRP), quality of life, anxiety and depression, self-efficacy and other conditions in the blood results of the patients before and after intervention.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Regular diet group

Explain disease related knowledge; According to the patient's situation, give personalized dietary guidance, establish regular eating habits, carefully evaluate the types of food in the food, and avoid spicy stimulation, gas production, high fat and other foods that are easy to cause intestinal discomfort. SMS follow-up was conducted 3 days after discharge, and weekly phone follow-up was conducted to see if patients needed to solve problems and help them solve them in time.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Anti-inflammatory diet group

AID knowledge education was given to patients in the intervention group after admission. At the same time, patients are asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by researchers, and teach patients how to use it, including the choice of anti-inflammatory diet, inappropriate anti-inflammatory diet, diet alarm clock, diet notes and other related functions. Missionary patients persisted with AID until re-examination 8 weeks later.

The researchers conducted weekly telephone follow-up to urge the patients to adhere to the AID diet, answer the questions raised by the patients during the implementation process, and understand the patients' knowledge acceptance and diet implementation. Follow-up is carried out by qualified members of the training research team. Follow-up can take the form of face-to-face visit to the community or direct telephone follow-up, and make follow-up records.

Group Type: EXPERIMENTAL

Anti-inflammatory diet group

Intervention Type: BEHAVIORAL

Patients in the intervention group were given AID knowledge education, and patients were asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by the researchers to teach patients how to use it, including the selection of anti-inflammatory diet, unsuitable anti-inflammatory diet, diet alarm clock, diet notes and other related functions. The missionary patients insisted on AID until reexamination 8 weeks later.

Interventions

Anti-inflammatory diet group

Patients in the intervention group were given AID knowledge education, and patients were asked to pay attention to the "anti-inflammatory diet" wechat mini program developed by the researchers to teach patients how to use it, including the selection of anti-inflammatory diet, unsuitable anti-inflammatory diet, diet alarm clock, diet notes and other related functions. The missionary patients insisted on AID until reexamination 8 weeks later.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of inflammatory bowel disease, the diagnostic criteria refer to the 2018 revised Consensus opinion on the diagnosis and treatment of inflammatory bowel disease;

2. The patient has clear consciousness and certain understanding, language expression and writing ability;

3. Patients participated in this study knowingly and voluntarily;

4. At least 18 years old.

Exclusion Criteria

1. cognitive impairment, mental illness, accompanied by mental disorders;

2. Alcohol and drug abusers.

3. The patient could not participate in the researcher due to the deterioration of the condition;

4. Patients who voluntarily quit due to other reasons;

5. Those who did not complete the assessment scale during the experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xia Qian, BA

Role: PRINCIPAL_INVESTIGATOR

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Locations

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xia Qian, BA

Role: CONTACT

1632936247@qq.com

15968110117

Lili Yang, PhD

Role: CONTACT

3200006@zju.edu.cn

13958131637

Facility Contacts

Xia Qian, BA

Role: primary

1632936247@qq.com

15968110117

Other Identifiers

KY-2024-039

Identifier Type: -

Identifier Source: org_study_id