Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients

Validating Efficacy for Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Change, Body
• Intervention / Treatment: Behavioral: Digital lifestyle management

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyu Eun Lee; Phone Number: +821092738292; Email: kyueunlee@snu.ac.kr
• Study Contact Backup: Name: JungHak Kwak; Phone Number: +821040700477; Email: jhkwak908@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Kyu Eun Lee, Ph.D; Email: kyu.eun.lee.md@gmail.com
    • Principal Investigator: Kyu Eun Lee, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Digital lifestyle management; Digital lifestyle management for Weight Loss Control after Thyroidectomy
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Change from baseline weight at 4 months and 6 months after surgery	baseline, 4 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	baseline, 4 months, 6 months
Changes of waist circumstance	Waist circumstance difference	baseline, 4 months, 6 months
Changes of hip circumstance	Hip circumstance difference	baseline, 4 months, 6 months
Changes of body fat percent	Body fat percent difference	baseline, 4 months, 6 months
Changes of lean body mass	Lean body mass difference	baseline, 4 months, 6 months
Changes of total cholesterol level	Biological index	baseline, 4 months, 6 months
Changes of HDL cholesterol level	Biological index	baseline, 4 months, 6 months
Changes of LDL cholesterol level	Biological index	baseline, 4 months, 6 months
Changes of triglyceride level	Biological index	baseline, 4 months, 6 months
Changes of aspartate aminotransferase (AST) level	Biological index	baseline, 4 months, 6 months
Changes of alanine aminotransferase (ALT) level	Biological index	baseline, 4 months, 6 months
Changes of gamma-glutamyl transferase (GGT) level	Biological index	baseline, 4 months, 6 months
Changes of free T3 level	Biological index	baseline, 4 months, 6 months
Changes of free T4 level	Biological index	baseline, 4 months, 6 months
Changes of TSH level	Biological index	baseline, 4 months, 6 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Kyu Eun Lee, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Anticipated): August 30, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: September 26, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Thyroid cancer; Digital lifestyle management; Total thyroidectomy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Weight Loss; Body Weight; Body Weight Changes; Thyroid Neoplasms
• Other Study ID Numbers: 2105-192-1224

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No