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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Digital lifestyle management for Weight Loss Control after Thyroidectomy
Seoul National University Hospital
Seoul, South Korea
RECRUITINGWeight change
Change from baseline weight at 4 months and 6 months after surgery
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
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
Time frame: baseline, 4 months, 6 months
Changes of waist circumstance
Waist circumstance difference
Time frame: baseline, 4 months, 6 months
Changes of hip circumstance
Hip circumstance difference
Time frame: baseline, 4 months, 6 months
Changes of body fat percent
Body fat percent difference
Time frame: baseline, 4 months, 6 months
Changes of lean body mass
Lean body mass difference
Time frame: baseline, 4 months, 6 months
Changes of total cholesterol level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of HDL cholesterol level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of LDL cholesterol level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of triglyceride level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of aspartate aminotransferase (AST) level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of alanine aminotransferase (ALT) level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of gamma-glutamyl transferase (GGT) level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of free T3 level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of free T4 level
Biological index
Time frame: baseline, 4 months, 6 months
Changes of TSH level
Biological index
Time frame: baseline, 4 months, 6 months
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