- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05922553
Using Mukbang to Improve Appetite, Nutritional Status and Quality of Life in Children With Cancer
The Effectiveness of Mukbang in Helping Children With Cancer Hospitalized for Radiotherapy and Chemotherapy to Improve Appetite, Nutritional Status and Quality of Life: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cancer has a high incidence among children and adolescents worldwide. In October 2020, the World Health Organization (WHO) released an overview of the Global Action on Childhood Cancer which showed that more than 400,000 children under the age of 19 were diagnosed with cancer worldwide every year. With the development and progress of diagnosis and treatment technology, the health outcome of children with cancer has been greatly improved.
However, the side effects and complications associated with cancer and its treatment can seriously affect the appetite and food intake of children with cancer, resulting in malnutrition and a low quality of life. Therefore, it is very important to effectively improve the appetite of children with cancer during treatment.
Clinical methods to improve the appetite of cancer patients mainly include drugs, diet or nutrition intervention, traditional Chinese medicine and acupuncture, but each intervention has its own advantages and disadvantages which makes the clinical application effect difficult to evaluate, in urgent need of more effective solutions to solve this problem.
Mukbang has shown great potential in helping children with cancer to improve their appetite and food consumption, finally promote nutritional health. What's more, the features of Mukbang, such as high-quality and clear pictures, relaxed atmosphere created by the video makers, sounds while eating, and attractive images of food, may promote viewers' appetite and increase their intake imperceptibly. In addition to that, watching Mukbang while eating can also provide a pleasant eating experience for children with cancer, and the interaction with the Mukbang anchor can also alleviate the loneliness of children who live in hospital for such a long time, so as to enhance the children's taste experience, relieve the negative emotions of loneliness and depression.
Research has found that Mukbang can help people with low appetites increase their food intake and the interest in food. Several studies have shown that videos containing food cues can increase viewers' appetite and decrease feelings of satiety to a certain extent. At the same time, Mukbang can also increase viewers' taste experience on the basis of physics and improve children's interest in food. Thus, Mukbang is a useful tool for those who are struggling to increase the amount and variety of acceptable foods and gain weight. It also suggests that clinicians who treat eating disorders should be aware that Mukbang is a potential factor in their illness, and that effective positive use may be helpful for patients with anorexia or restrictive eating.
Given that, Mukbang will be applied to help children with cancer to improve appetite, nutritional status and quality of life. Studies have found that food images, eating sounds and interactivity of Mukbang may play a leading role in improving appetite. Thus, we defined the active ingredients of Mukbang as food images, eating sound and interactivity in this study. Based on that, this study aims to compare the effect of active ingredient Mukbang and general short videos without food cues on improving appetite in children with cancer, to provide evidence for larger randomized controlled trials (RCTS) and provide a new direction for clinical departments to develop nutritional interventions and management programs for children with cancer.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wei Xia, PhD
- Phone Number: +8618823359471
- Email: xiaw23@mail.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510080
- Recruiting
- Sun Yat-Sen Memorial Hospital
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Contact:
- Wei Xia, PhD
- Phone Number: +8618823359471
- Email: xiaw23@mail.sysu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 6 to 18 years old;
- Children in accordance with the guidelines for the Diagnosis and Treatment of 12 Diseases related to hematologic diseases and malignant tumors (2021 version) issued by the General Office of the National Health Commission;
- At least experience one full cycle of chemotherapy;
- Children with moderate or higher symptoms of decreased appetite were screened for a list of treatment-related symptoms.
Exclusion Criteria:
- Children with serious cardiopulmonary disease, infection, organ damage, or genetic metabolic disease, immune deficiency disease, mental illness;
- Children with eye or ear dysfunction that prevents them from watching and listening to videos.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Ingredient Mukbang
Active Ingredient Mukbang will be allocated to the participants in the experimental group.
The videos which presented the food images, eating sound and a relaxing and pleasant atmosphere will be sent in sequence through the short video platforms on the smart phone to the participants in the experimental group.
|
Mukbang videos include the items which can truly improve the appetite of children with cancer, such as food images, eating sound and interactivity.
|
|
Placebo Comparator: General short videos
General short videos without food cues will be allocated to the participants in the placebo control group.
There will be no restrictions on the type of short video platforms and specific video content.
|
Short videos that don't contain any food cues.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported appetite during the intervention
Time Frame: Change from baseline appetite during 7 days intervention
|
A subjective sensation that stimulates the intake of food to provide the energy necessary for the most basic activities of life, which can be measured by the Cancer Appetite and Symptom Questionnaire (CASQ).
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Change from baseline appetite during 7 days intervention
|
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Self-reported appetite during the intervention
Time Frame: Change from baseline appetite at 4 weeks follow-up
|
A subjective sensation that stimulates the intake of food to provide the energy necessary for the most basic activities of life, which can be measured by the Cancer Appetite and Symptom Questionnaire (CASQ).
|
Change from baseline appetite at 4 weeks follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The level of nutritional status
Time Frame: Change from baseline nutritional status at 7 days
|
Insufficient or excessive nutrient intake, imbalance of essential nutrients or impaired nutrient utilization, mainly manifested by wasting, stunting, underweight and micronutrient deficiency.
Malnutrition is measured by the Subjective Global Nutritional Risk Assessment (SGNA).
|
Change from baseline nutritional status at 7 days
|
|
The level of nutritional status
Time Frame: Change from baseline nutritional status at 4-weeks follow-up
|
Insufficient or excessive nutrient intake, imbalance of essential nutrients or impaired nutrient utilization, mainly manifested by wasting, stunting, underweight and micronutrient deficiency.
Malnutrition is measured by the Subjective Global Nutritional Risk Assessment (SGNA).
|
Change from baseline nutritional status at 4-weeks follow-up
|
|
The level of the body mass index of the children with cancer
Time Frame: Change from baseline BMI at 7 days
|
Body mass index (BMI), a simple method to evaluate the nutritional status and changes of children with cancer, which will be calculated as weight/height^2.
Weight and height will be combined to report BMI in kg/m^2.
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Change from baseline BMI at 7 days
|
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The level of the body mass index of the children with cancer
Time Frame: Change from baseline BMI at 4-weeks follow-up
|
Body mass index (BMI), a simple method to evaluate the nutritional status and changes of children with cancer, which will be calculated as weight/height^2.
Weight and height will be combined to report BMI in kg/m^2.
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Change from baseline BMI at 4-weeks follow-up
|
|
The quality of life after the intervention
Time Frame: Change from baseline quality of life at 7 days
|
Individuals in different cultures and value systems experience their living conditions in relation to their goals, expectations, standards and concerns, including their physical health, mental state, independence, social relations, personal beliefs and relationships with the surrounding environment.
This target is measured by the pediatric quality of life inventory measurement models 3.0 (PedsQLTM-3.0-cancer).
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Change from baseline quality of life at 7 days
|
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The quality of life after the intervention
Time Frame: Change from baseline quality of life at 4-weeks follow-up
|
Individuals in different cultures and value systems experience their living conditions in relation to their goals, expectations, standards and concerns, including their physical health, mental state, independence, social relations, personal beliefs and relationships with the surrounding environment.
This target is measured by the pediatric quality of life inventory measurement models 3.0 (PedsQLTM-3.0-cancer).
|
Change from baseline quality of life at 4-weeks follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wei Xia, PhD, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- mukbang RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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