Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Obesity

Body Weight

Body Weight Changes

Weight Gain

Chronic Graft Versus Host Disease

Participants randomized to the HH/HF study intervention will work with a coach through phone calls and text messages for 12 weeks to set goals targeting home-based environmental determinants of dietary behaviors.

Participants in the control condition will receive two mailings which focus on the same dietary outcomes as the HH/HF intervention but without the home environment emphasis.

The HH/HF Intervention involves coaching calls, text messages and intervention materials that are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. The intervention is delivered over a 12 week period.

Health Homes/Healthy Families (HH/HF) Intervention

Participants in the control condition will receive two mailings on healthy eating, the first from the "Dietary Guidelines For Americans 2015-2020, 8th Edition" and the second from "Choose MyPlate". Additionally, both mailings will include a food diary from the Centers for Disease Control and Prevention. Mailings will be sent to participants one and six-weeks post-baseline. These materials focus on the same dietary outcomes being targeted in the HH/HF intervention, but without the home environment emphasis. Control group participants will receive their home environment profile with a list of healthy actions upon completion of the study.

Control

Michelle Kegler, DrPH/MPH

This trial will evaluate a healthy eating and weight gain prevention intervention for delivery through calls to the 2-1-1 number.

It is now well-established that obesity and excess weight increase the risk of cancer (i.e., colorectal and post-menopausal breast cancer), as well as other chronic diseases including diabetes, stroke, coronary heart disease, and arthritis. The World Cancer Research Fund and the American Institute for Cancer Research state "maintenance of a healthy weight throughout life may be one of the most important ways to protect against cancer". Unfortunately, adults generally gain weight as they age.

Healthy Homes/Healthy Families (HH/HF) Intervention involves a tailored home environment profile and a health coach working with participants to select and implement a series of healthy actions to create a home environment more supportive of healthy eating and physical activity.

The Federal Communications Commission (FCC) designated 2-1-1 as the 3-digit number to call for information and referrals to social services and other assistance in the United States. This study will evaluate a healthy eating and weight gain prevention intervention for delivery through 2-1-1 calls.

Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers

A Hybrid Effectiveness-Implementation Study on Weight Gain Prevention Among 2-1-1 Callers

Individual participant data that underlie the results, after de-identification will be shared

The USDA HEI measures diet quality and is calculated from two telephone administered 24-hr dietary recalls (one weekday, one weekend day). The HEI evaluates foods with a scoring system using 13 components for different food groups and the key recommendations of the 2015-2020 "Dietary Guidelines for Americans". Scores range from 0 to 100 where a score of 100 is an ideal score indicating that a diet follows the key recommendations of the 2015-2020 "Dietary Guidelines for Americans".

Kcal per day will be calculated and recorded. The most recent version of the Automated Self-Administered 24-hour dietary recall (ASA24) program prompts for food description details and automatically codes and calculates nutrient intakes using the USDA Food and Nutrient Database for Dietary Studies. The average of one weekday and one weekend day will be used to estimate Kcal per day at each time point.

Participants will self-report weight in pounds each time point

A home environment survey will be administered via telephone at each time point to assess household food inventory, food preparation methods, meals/snacks with the television on, use of non-home food sources for family meals, and frequency of shopping for fruits and vegetables.

Centers for Disease Control and Prevention

Emory University

Professor

Gland and Hormone Related Diseases

Neoplasms

Thyroid Diseases

Weight Loss

Thyroid Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

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.

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.

Digital lifestyle management for Weight Loss Control after Thyroidectomy

Digital lifestyle management

Kyu Eun Lee

JungHak Kwak

Kyu Eun Lee, Ph.D

Kyu Eun Lee, MD, Ph.D

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.

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

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

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

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

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

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

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

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

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

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

Seoul National University Hospital

Malnutrition

Kwashiorkor

Nutrition Disorders

Severe Acute Malnutrition

Acute Graft Versus Host Disease

artificial intelligence dietary application, iDSA, will be introduced and installed. Explanation on the function and application of iDSA will be given. Daily energy and macro-nutrients requirement target will bed set. The daily energy and macronutrients requirement target is secured by password. Subjects will record their daily dietary intake (food with cooking method and portion size) and nutrition impact symptoms via smartphone application at least 3 times a week. Subjects able to keep track their intake at home. During follow up session, subjects show the iDSA diet intake summary records to Researcher for further assessment.

CG will receive conventional dietitian care includes nutrition care process using conventional 24 hours diet recall method for dietary assessment

subjects use artificial intelligence dietary mobile application to monitor dietary intake

artificial intelligence dietary android mobile application

Chiou Yi Ho

Multi-center prospective pilot trial study

This is a clinical study to evaluate impact of dietary smartphone application on nutritional status among cancer patients. the study hypotheses there is improvement in nutritional outcome in intervention group if compare with control group. the eligible subjects will be screened according to inclusion criteria and approached individually to participate in this study. The consented subjects will be divided randomly into two groups, intervention and conventional groups. Conventional dietitian care will be given to conventional group (CG) while intervention group (IG) will received innovated dietitian care where they will be introduced with iDSA apps and installed in consented subjects' smartphone. All subjects will be reviewed again by dietitian in 1-month time to assess nutritional status (weight and energy protein intake) as well as nutrition impact symptoms.

The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients

compare weight before intervention and after intervention

compare daily energy intake before intervention and after intervention

compare daily protein intake before intervention and after intervention

compare PG-SGA score (numerical data) before intervention and after intervention

compare NIS score (scale data) before intervention and after intervention. The score range from 1 to 5 where score 1 is better while score 5 is worst

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers	NCT04373434	Weight Change, ...	Health Homes/He... Control	18 Years - 70 Years	Emory University
Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients	NCT05126706	Weight Change, ...	Digital lifesty...	19 Years - 70 Years	Seoul National University Hospital
Healthy Homes/Healthy Families (HH/HF) Intervention in 2-1-1 Callers	NCT04373434	Weight Change, ...	Health Homes/He... Control	18 Years - 70 Years	Emory University
Digital Lifestyle Management for Weight Loss Control After Thyroidectomy in Thyroid Cancer Patients	NCT05126706	Weight Change, ...	Digital lifesty...	19 Years - 70 Years	Seoul National University Hospital
The Impact of Artificial Intelligence Dietary Smartphone Application on Nutritional Status Among Cancer Patients	NCT04643626	Malnutrition, C... Malnutrition; P... Weight Change, ...	artificial inte...	18 Years -	Universiti Putra Malaysia

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