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Weight Change, BodyNCT05126706

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

A study testing Digital lifestyle management in people with Weight Change, Body, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Weight Change, Body
What is being tested?
Digital lifestyle management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
12 Nov 2021to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Kyu Eun Lee contact

+821092738292

kyueunlee@snu.ac.kr

JungHak Kwak contact

+821040700477

jhkwak908@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 110-744

    Kyu Eun Lee, Ph.D, kyu.eun.lee.md@gmail.com

    Kyu Eun Lee, MD, Ph.D

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Digital lifestyle management
Keywords
Digital lifestyle management, Thyroid cancer, Total thyroidectomy, Obesity
Medical subject headings
Body Weight Changes, Thyroid Neoplasms, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital lifestyle managementBehavioural

    Digital lifestyle management for Weight Loss Control after Thyroidectomy

Study groups in NCT05126706
Study groupRoleWhat they receive
Digital lifestyle management groupExperimentalIn 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.
Receives: Behavioral: Digital lifestyle management
Non-digital lifestyle management groupNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight change

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

    Measured: baseline, 4 months, 6 months

Secondary outcomes (22)

  1. 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

    Measured: baseline, 4 months, 6 months

  2. 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

    Measured: baseline, 4 months, 6 months

  3. 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

    Measured: baseline, 4 months, 6 months

  4. 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

    Measured: baseline, 4 months, 6 months

  5. 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

    Measured: baseline, 4 months, 6 months

  6. 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

    Measured: baseline, 4 months, 6 months

  7. 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

    Measured: baseline, 4 months, 6 months

  8. 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

    Measured: baseline, 4 months, 6 months

  9. Changes of waist circumstance

    Waist circumstance difference

    Measured: baseline, 4 months, 6 months

  10. Changes of hip circumstance

    Hip circumstance difference

    Measured: baseline, 4 months, 6 months

  11. Changes of body fat percent

    Body fat percent difference

    Measured: baseline, 4 months, 6 months

  12. Changes of lean body mass

    Lean body mass difference

    Measured: baseline, 4 months, 6 months

  13. Changes of total cholesterol level

    Biological index

    Measured: baseline, 4 months, 6 months

  14. Changes of HDL cholesterol level

    Biological index

    Measured: baseline, 4 months, 6 months

  15. Changes of LDL cholesterol level

    Biological index

    Measured: baseline, 4 months, 6 months

  16. Changes of triglyceride level

    Biological index

    Measured: baseline, 4 months, 6 months

  17. Changes of aspartate aminotransferase (AST) level

    Biological index

    Measured: baseline, 4 months, 6 months

  18. Changes of alanine aminotransferase (ALT) level

    Biological index

    Measured: baseline, 4 months, 6 months

  19. Changes of gamma-glutamyl transferase (GGT) level

    Biological index

    Measured: baseline, 4 months, 6 months

  20. Changes of free T3 level

    Biological index

    Measured: baseline, 4 months, 6 months

  21. Changes of free T4 level

    Biological index

    Measured: baseline, 4 months, 6 months

  22. Changes of TSH level

    Biological index

    Measured: baseline, 4 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start12 Nov 2021
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05126706
Sponsor's protocol ID
2105-192-1224
Status last verified
Nov 2021
First submitted
26 Sep 2021
Last updated
19 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital lifestyle management in people with Weight Change, Body, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kyu Eun Lee (+821092738292, kyueunlee@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight change (time frame: baseline, 4 months, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05126706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.

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