Validating Efficacy for Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Weight change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Weight change
时间窗: baseline, 4 months, 6 months
Change from baseline weight at 4 months and 6 months after surgery
次要结局
- Changes of hip circumstance(baseline, 4 months, 6 months)
- Changes of HDL cholesterol level(baseline, 4 months, 6 months)
- Changes of aspartate aminotransferase (AST) level(baseline, 4 months, 6 months)
- Changes of lean body mass(baseline, 4 months, 6 months)
- Changes of total cholesterol level(baseline, 4 months, 6 months)
- Changes of triglyceride level(baseline, 4 months, 6 months)
- Changes of waist circumstance(baseline, 4 months, 6 months)
- Changes of body fat percent(baseline, 4 months, 6 months)
- Changes of gamma-glutamyl transferase (GGT) level(baseline, 4 months, 6 months)
- Changes of free T3 level(baseline, 4 months, 6 months)
- Changes of free T4 level(baseline, 4 months, 6 months)
- Changes of LDL cholesterol level(baseline, 4 months, 6 months)
- Changes of alanine aminotransferase (ALT) level(baseline, 4 months, 6 months)
- Changes of TSH level(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (Rosenberg Self-Esteem Scale (RSES))(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (Body Shape Questionnaire (BSQ-8C) )(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (Dutch Eating Behaviour Questionnaire (DEBQ))(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (Korean Obesity Quality of Life (KOQOL))(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (World Health Organization Quality of Life - Brief Form (WHOQOL-Bref))(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (Pittsburgh Sleep Quality Index (PSQI))(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (Korean-Beck Depression Inventory-II (K-BDI-II))(baseline, 4 months, 6 months)
- Changes of results about questionnaires for quality of life (State-Trait Anxiety Inventory (STAI))(baseline, 4 months, 6 months)
研究者
Kyu Eun Lee
Professor
Seoul National University Hospital