Back to resultsDigital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients
Primary Purpose
Weight Change, Body
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Digital lifestyle management
Sponsored by
About this trial
This is an interventional supportive care trial for Weight Change, Body focused on measuring Digital lifestyle management, Thyroid cancer, Total thyroidectomy, Obesity
Eligibility Criteria
Inclusion Criteria:
- Target: Among the patients who have undergone thyroidectomy, patients who are interested in weight management and can use the Noom app by themselves or with the help of neighbors.
- 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:
- The patient was diagnosed with chronic diseases (hepatic disease, kidney disease, diabetes, etc.).
- 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).
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Digital lifestyle management group
Non-digital lifestyle management group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Weight change
Change from baseline weight at 4 months and 6 months after surgery
Secondary Outcome Measures
Changes of results about questionnaires for quality of life (Korean Obesity Quality of Life (KOQOL))
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Korean Obesity Quality of Life (KOQOL)
Range: 4-60
Higher scores: impaired QOL
Changes of results about questionnaires for quality of life (World Health Organization Quality of Life - Brief Form (WHOQOL-Bref))
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# World Health Organization Quality of Life - Brief Form (WHOQOL-Bref)
Range: 0-100
Higher scores: higher QOL
Changes of results about questionnaires for quality of life (Pittsburgh Sleep Quality Index (PSQI))
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Pittsburgh Sleep Quality Index (PSQI)
Range: 0-21
Lower scores: a healthier sleep quality
Changes of results about questionnaires for quality of life (Korean-Beck Depression Inventory-II (K-BDI-II))
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Korean-Beck Depression Inventory-II (K-BDI-II)
Range: 0-63
Higher scores: Depression
Changes of results about questionnaires for quality of life (State-Trait Anxiety Inventory (STAI))
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# State-Trait Anxiety Inventory (STAI)
Range: 20-80
Higher scores: anxiety
Changes of results about questionnaires for quality of life (Rosenberg Self-Esteem Scale (RSES))
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Rosenberg Self-Esteem Scale (RSES)
Range: 0-30
Higher scores: lower self-esteem
Changes of results about questionnaires for quality of life (Body Shape Questionnaire (BSQ-8C) )
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Body Shape Questionnaire (BSQ-8C)
Range: 8-48
Higher values: body dissatisfaction
Changes of results about questionnaires for quality of life (Dutch Eating Behaviour Questionnaire (DEBQ))
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Dutch Eating Behaviour Questionnaire (DEBQ)
Range: 33-165
Higher scores: the eating behavior
Changes of waist circumstance
Waist circumstance difference
Changes of hip circumstance
Hip circumstance difference
Changes of body fat percent
Body fat percent difference
Changes of lean body mass
Lean body mass difference
Changes of total cholesterol level
Biological index
Changes of HDL cholesterol level
Biological index
Changes of LDL cholesterol level
Biological index
Changes of triglyceride level
Biological index
Changes of aspartate aminotransferase (AST) level
Biological index
Changes of alanine aminotransferase (ALT) level
Biological index
Changes of gamma-glutamyl transferase (GGT) level
Biological index
Changes of free T3 level
Biological index
Changes of free T4 level
Biological index
Changes of TSH level
Biological index
Full Information
NCT ID
NCT05126706
First Posted
September 26, 2021
Last Updated
November 18, 2021
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05126706
Brief Title
Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients
Official Title
Validating Efficacy for Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Thyroid hormones play an important role in the regulation of the body's metabolism. But the relationship between thyroid hormone status and the basal metabolism rate is not absolute. Because thyroid hormone function is not the only factor of control the metabolism and it can be influenced by various factors such as physical activity and diet.
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
The present study is a prospective randomized control trial. A total of 80 patients who underwent total thyroidectomy for thyroid cancer is included. Fifty-four patients are randomly assigned to the digital lifestyle management group and the other 26 patients are assigned to the non-digital lifestyle management group.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Change, Body
Keywords
Digital lifestyle management, Thyroid cancer, Total thyroidectomy, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital lifestyle management group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-digital lifestyle management group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital lifestyle management
Intervention Description
Digital lifestyle management for Weight Loss Control after Thyroidectomy
Primary Outcome Measure Information:
Title
Weight change
Description
Change from baseline weight at 4 months and 6 months after surgery
Time Frame
baseline, 4 months, 6 months
Secondary Outcome Measure Information:
Title
Changes of results about questionnaires for quality of life (Korean Obesity Quality of Life (KOQOL))
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Korean Obesity Quality of Life (KOQOL)
Range: 4-60
Higher scores: impaired QOL
Time Frame
baseline, 4 months, 6 months
Title
Changes of results about questionnaires for quality of life (World Health Organization Quality of Life - Brief Form (WHOQOL-Bref))
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# World Health Organization Quality of Life - Brief Form (WHOQOL-Bref)
Range: 0-100
Higher scores: higher QOL
Time Frame
baseline, 4 months, 6 months
Title
Changes of results about questionnaires for quality of life (Pittsburgh Sleep Quality Index (PSQI))
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Pittsburgh Sleep Quality Index (PSQI)
Range: 0-21
Lower scores: a healthier sleep quality
Time Frame
baseline, 4 months, 6 months
Title
Changes of results about questionnaires for quality of life (Korean-Beck Depression Inventory-II (K-BDI-II))
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Korean-Beck Depression Inventory-II (K-BDI-II)
Range: 0-63
Higher scores: Depression
Time Frame
baseline, 4 months, 6 months
Title
Changes of results about questionnaires for quality of life (State-Trait Anxiety Inventory (STAI))
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# State-Trait Anxiety Inventory (STAI)
Range: 20-80
Higher scores: anxiety
Time Frame
baseline, 4 months, 6 months
Title
Changes of results about questionnaires for quality of life (Rosenberg Self-Esteem Scale (RSES))
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Rosenberg Self-Esteem Scale (RSES)
Range: 0-30
Higher scores: lower self-esteem
Time Frame
baseline, 4 months, 6 months
Title
Changes of results about questionnaires for quality of life (Body Shape Questionnaire (BSQ-8C) )
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Body Shape Questionnaire (BSQ-8C)
Range: 8-48
Higher values: body dissatisfaction
Time Frame
baseline, 4 months, 6 months
Title
Changes of results about questionnaires for quality of life (Dutch Eating Behaviour Questionnaire (DEBQ))
Description
Change from baseline results of questionnaires at 4 months and 6 months after surgery
# Dutch Eating Behaviour Questionnaire (DEBQ)
Range: 33-165
Higher scores: the eating behavior
Time Frame
baseline, 4 months, 6 months
Title
Changes of waist circumstance
Description
Waist circumstance difference
Time Frame
baseline, 4 months, 6 months
Title
Changes of hip circumstance
Description
Hip circumstance difference
Time Frame
baseline, 4 months, 6 months
Title
Changes of body fat percent
Description
Body fat percent difference
Time Frame
baseline, 4 months, 6 months
Title
Changes of lean body mass
Description
Lean body mass difference
Time Frame
baseline, 4 months, 6 months
Title
Changes of total cholesterol level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of HDL cholesterol level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of LDL cholesterol level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of triglyceride level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of aspartate aminotransferase (AST) level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of alanine aminotransferase (ALT) level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of gamma-glutamyl transferase (GGT) level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of free T3 level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of free T4 level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
Title
Changes of TSH level
Description
Biological index
Time Frame
baseline, 4 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Target: Among the patients who have undergone thyroidectomy, patients who are interested in weight management and can use the Noom app by themselves or with the help of neighbors.
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:
The patient was diagnosed with chronic diseases (hepatic disease, kidney disease, diabetes, etc.).
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyu Eun Lee
Phone
+821092738292
Email
kyueunlee@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
JungHak Kwak
Phone
+821040700477
Email
jhkwak908@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Eun Lee
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyu Eun Lee, Ph.D
Email
kyu.eun.lee.md@gmail.com
First Name & Middle Initial & Last Name & Degree
Kyu Eun Lee, MD, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients
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