Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients
NCT ID: NCT05126706
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-11-12
2024-08-30
Brief Summary
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Weight change after thyroidectomy is one of the concerns for thyroid cancer patients. The evidence on the bodyweight changes following thyroidectomy has not been established well. Being overweight and obese can increase the risk of developing many potential health problems, such as heart disease, diabetes, high blood pressure, and malignant disease.
Recently, digital health care technology has been developed and applied for medical purposes in many clinical practices. Digital Lifestyle Management is one of the strategies that can be helpful for the obese to control their body weight by lifestyle modification. It provides comprehensive, multifactorial, intensive interventions which are delivered via the digital health care mobile service Noom application.
The aim of this study is to evaluate the efficacy of digital lifestyle management on body weight and quality of life after total thyroidectomy in thyroid cancer patients by using the digital health care Noom application.
Detailed Description
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In the experimental group (digital lifestyle management group), the patients will use this application for the first 4 months with Noom applications with 1:1 personalized coaching intervention, and then, use this app by self-help program without coaching intervention. The digital lifestyle management program will record the patient's meals, exercise, steps taken, reading articles, and give feedback to each patient. In order to monitor the psychological state and quality of life of the patients, online questionnaires will be provided.
In the control group (non-digital lifestyle management group), the patients will get the conventional postoperative care protocol without using the Noom application. To investigate the weight change and quality of life, variables are collected at baseline, 4 months, and 6 months after surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Digital lifestyle management group
In the experimental group (digital lifestyle management group), 54 patients are randomly assigned to the digital lifestyle management group. The patients use this application for the first 4 months with Noom applications with 1:1 personalized coaching intervention, and then, use this app by self-help program without coaching intervention. In order to monitor the psychological state of the patients, all the patients are given daily assessment online questionnaires and additional questionnaires to evaluate the quality of life at the baseline, 4 months, and 6 months after surgery. To assess the nutritional status of the patients, we collect blood laboratory data, bioimpedance analysis for each visit.
Digital lifestyle management
Digital lifestyle management for Weight Loss Control after Thyroidectomy
Non-digital lifestyle management group
In the control group (Non-digital lifestyle management group), 26 patients are randomly assigned to the control group (Non-digital lifestyle management group). The patients follow conventional postoperative care protocol after total thyroidectomy for thyroid cancer without using Noom application. All patients are given questionnaires to evaluate the quality of life at the baseline, 4 months, and 6 months after surgery. To assess the nutritional status of the patients, we collect blood laboratory data, bioimpedance analysis for each visit.
No interventions assigned to this group
Interventions
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Digital lifestyle management
Digital lifestyle management for Weight Loss Control after Thyroidectomy
Eligibility Criteria
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Inclusion Criteria
* The patient has 23 or more BMI at the time of enrollment.
* In The Situational Motivation Scale (SIMS), a total of five stages of synchronization level of 68 or higher, which is the top 40% of the 112 points (1st stage: pre-consumption stage; stage 2: deliberation stage; stage 3: preparation stage; stage 4: action stage)
* The patient agreed about participating in this study.
Exclusion Criteria
* In the case where there is no member who can support among family members,
* The patient who is not a smartphone or has difficulty using digital technology.
* When it is difficult to lose weight (pregnancy and pregnancy preparation, breastfeeding, and less than 12 months after childbirth)
* If the patient has a history of psychiatric illness (eating disorder, depression, etc.).
* If the patient is taking diet-related drugs or health supplements, or treatments.
* If there is a restriction on physical activity (not allowed to exercise for more than 30 minutes a day).
19 Years
70 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Kyu Eun Lee
Professor
Principal Investigators
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Kyu Eun Lee
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Kyu Eun Lee, Ph.D
Role: primary
Other Identifiers
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2105-192-1224
Identifier Type: -
Identifier Source: org_study_id