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

NCT05126706 | Unknown DMC

• 1 other identifier: 2105-192-1224
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Change, Body

Keywords

Digital lifestyle management; Thyroid cancer; Total thyroidectomy; Obesity

Outcome Measures

Primary Outcomes (1)

• Weight change

  Change from baseline weight at 4 months and 6 months after surgery

  baseline, 4 months, 6 months

Secondary Outcomes (22)

• 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

Study Arms (2)

Digital lifestyle management group

EXPERIMENTAL

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

Non-digital lifestyle management group

NO INTERVENTION

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.

Interventions

Digital lifestyle management BEHAVIORAL

Digital lifestyle management for Weight Loss Control after Thyroidectomy

Digital lifestyle management group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Body Weight Changes; Thyroid Neoplasms; Obesity

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Kyu Eun Lee

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyu Eun Lee

CONTACT

+821092738292; kyueunlee@snu.ac.kr

JungHak Kwak

CONTACT

+821040700477; jhkwak908@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: November 19, 2021
• Study Start: November 12, 2021
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

KR (1)