Nudge-Based Exercise Intervention for Adolescents With Obesity
16 сентября 2026 г. обновлено: Chenxin Gan, Nanjing Children's Hospital
Development and Application of a Nudge-Based Exercise Program for Adolescents With Obesity
This study will evaluate whether a nudge-based exercise program can improve body mass index (BMI) and physical activity in adolescents with obesity. About 140 adolescents aged 10-19 years will participate. Participants will be placed into one of two groups according to the order in which they are admitted to the hospital. One group will receive a standard exercise intervention, while the other group will receive an 8-week nudge-based exercise program designed to make regular physical activity easier to start and maintain.
The nudge-based program uses simple behavioral strategies to make exercise easier to start and maintain, including framed and visual information, default exercise options, reminders, peer comparison and support, goal commitment, progress feedback, and small incentives. The program combines face-to-face sessions during hospitalization with home-based support, exercise tools, activity recording, and online follow-up.
The main outcomes are changes in BMI and physical activity. Other outcomes include body composition, blood metabolic markers, health-related quality of life, and exercise self-efficacy. Assessments will be conducted before and after the intervention, with follow-up assessments used to examine whether the effects are maintained over time.
Обзор исследования
Статус
Рекрутинг
Условия
Тип исследования
Интервенционный
Регистрация (Оцененный)
140
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Chenxin Gan
- Номер телефона: 18205049751
- Электронная почта: gcx5101@163.com
Места учебы
-
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Jiangsu
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Nanjing, Jiangsu, Китай
- Рекрутинг
- Nanjing Children's Hospital
-
Контакт:
- Chenxin Gan
- Номер телефона: 18205049751
- Электронная почта: gcx5101@163.com
-
Главный следователь:
- Yubing Wang
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- Aged 10-19 years.
- Body mass index (BMI) at or above the 95th percentile for age and sex according to the Chinese BMI screening criteria for overweight and obesity in children and adolescents.
- Able to communicate and understand study instructions.
- Willing to participate in the study and provide written informed consent, with informed consent from a parent or legal guardian as required.
Exclusion Criteria:
- Known secondary causes of obesity, including hypothalamic, endocrine, genetic, or syndromic obesity.
- Use of anti-obesity medications, including injectable glucagon-like peptide-1 (GLP-1) receptor agonists, within 3 months before enrollment.
- Severe cardiovascular or cerebrovascular disease, severe hepatic or renal dysfunction, or other serious organic diseases that may affect participation or study outcomes.
- Psychiatric disorders or cognitive impairment that may interfere with participation or completion of study assessments.
- Current participation in another weight-loss, structured exercise, or other intervention program that may affect body weight or physical activity.
- Any contraindication to exercise or medical or physical condition that substantially limits participation in the prescribed exercise program.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Standard Exercise Intervention
Participants in this arm receive a standardized exercise intervention based on current clinical guidance.
The program focuses on moderate-intensity aerobic exercise performed 3-4 times per week for 40-50 minutes per session.
Participants also receive routine exercise-related health education and follow-up support.
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Participants receive a standardized exercise program based on current clinical guidance.
The program primarily consists of moderate-intensity aerobic exercise performed 3-4 times per week for 40-50 minutes per session.
Participants also receive routine exercise-related health education and regular follow-up support.
|
|
Экспериментальный: Nudge-Based Exercise Intervention
Participants in this arm receive an 8-week nudge-based exercise intervention designed to promote the initiation and maintenance of physical activity.
The intervention uses strategies including framed and visual information, social reference, default exercise options, reminders, commitment, progress feedback, and incentives.
It combines structured face-to-face sessions during hospitalization with an exercise nudge package and home-based support through online reminders, activity recording, peer interaction, and incentives.
|
Participants receive an 8-week nudge-based exercise program designed to facilitate the initiation and maintenance of physical activity.
The intervention incorporates framed and visual information, social reference, default exercise options, reduced effort for accessing exercise opportunities, reminders, commitment strategies, progress feedback, and incentives.
During hospitalization, participants receive structured face-to-face sessions and an exercise nudge package containing exercise equipment, activity task cards, and a reminder device.
After discharge, home-based support is provided through online exercise reminders, activity recording, peer interaction, progress feedback, and incentives.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Body Mass Index (BMI)
Временное ограничение: Baseline and approximately 3 months after baseline
|
Body weight and height will be measured at baseline and approximately 3 months after baseline.
Weight in kilograms and height in meters will be combined to report a single BMI value using the formula: BMI = weight (kg) / [height (m)]^2.
Body weight and height are component measurements used to derive BMI for this endpoint and are not separate outcome measures.
Change in BMI will be calculated as the BMI value at approximately 3 months after baseline minus the baseline BMI value.
The reported unit of measure is kg/m^2.
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Baseline and approximately 3 months after baseline
|
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Change in Physical Activity
Временное ограничение: Baseline and approximately 3 months after baseline
|
Physical activity will be assessed using the Chinese version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
The questionnaire records walking, moderate-intensity, and vigorous-intensity physical activity during the previous 7 days.
The activity-specific values will be converted to metabolic equivalent of task minutes per week (MET-minutes/week) and summed according to the IPAQ-SF scoring method to generate a single total physical activity score.
The individual activity categories are components of the total score and are not separate outcome measures under this endpoint.
Change in physical activity from baseline to the follow-up assessment will be evaluated.
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Baseline and approximately 3 months after baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Total Sedentary Time
Временное ограничение: Baseline and approximately 3 months after baseline
|
Sedentary behavior will be assessed using a questionnaire that records time spent in common sedentary activities outside school hours on each day of a typical week, including screen-based activities, homework and reading, tutoring, motorized transportation, sedentary hobbies, social activities, and playing musical instruments.
Total sedentary time will be summarized as average minutes per day.
Change from baseline to follow-up will be evaluated.
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Baseline and approximately 3 months after baseline
|
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Change in Body Fat Percentage
Временное ограничение: Baseline and approximately 3 months after baseline
|
Body fat percentage will be measured by bioelectrical impedance analysis using the InBody H30 body composition analyzer and reported as a percentage (%).
Change from baseline to follow-up will be evaluated.
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Baseline and approximately 3 months after baseline
|
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Change in Skeletal Muscle Mass
Временное ограничение: Baseline and approximately 3 months after baseline
|
Skeletal muscle mass will be measured by bioelectrical impedance analysis using the InBody H30 body composition analyzer and reported in kilograms (kg).
Change from baseline to follow-up will be evaluated.
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Baseline and approximately 3 months after baseline
|
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Change in Exercise Self-Efficacy
Временное ограничение: Baseline and approximately 3 months after baseline
|
Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale (ESES), which evaluates participants' confidence in maintaining regular exercise when facing barriers such as fatigue, lack of time, or unfavorable weather.
Higher scores indicate greater exercise self-efficacy.
Change from baseline to follow-up will be evaluated.
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Baseline and approximately 3 months after baseline
|
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Change in Health-Related Quality of Life
Временное ограничение: Baseline and approximately 3 months after baseline
|
Health-related quality of life will be assessed using the Chinese version of the Pediatric Quality of Life Inventory Generic Core Scales.
The scale contains 23 items covering physical, emotional, social, and school functioning.
Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life.
Change in the total score from baseline to follow-up will be evaluated.
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Baseline and approximately 3 months after baseline
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Fasting Blood Glucose
Временное ограничение: Baseline and approximately 3 months after baseline
|
Fasting blood glucose will be assessed by laboratory testing after an overnight fast.
Change will be calculated as the follow-up value minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Fasting Insulin
Временное ограничение: Baseline and approximately 3 months after baseline
|
Fasting insulin will be assessed by laboratory testing after an overnight fast.
Change will be calculated as the follow-up value minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Временное ограничение: Baseline and approximately 3 months after baseline
|
Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting glucose and fasting insulin concentrations.
Higher values indicate greater insulin resistance.
Change will be calculated as the follow-up value minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Glycated Hemoglobin (HbA1c)
Временное ограничение: Baseline and approximately 3 months after baseline
|
Glycated hemoglobin (HbA1c) will be assessed by laboratory testing and reported as a percentage (%).
Change will be calculated as the follow-up value minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Total Cholesterol Concentration
Временное ограничение: Baseline and approximately 3 months after baseline
|
When available, total cholesterol concentration will be recorded from routine clinical laboratory testing performed during clinical re-examination and reported in millimoles per liter (mmol/L).
Change from baseline will be calculated as the value at approximately 3 months after baseline minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Triglyceride Concentration
Временное ограничение: Baseline and approximately 3 months after baseline
|
Triglyceride concentration will be recorded from routine clinical laboratory testing conducted as part of routine clinical re-examination and reported in millimoles per liter (mmol/L).
No additional blood sample will be collected solely for this study.
Change from baseline will be calculated as the value at approximately 3 months after baseline minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration
Временное ограничение: Baseline and approximately 3 months after baseline
|
Low-density lipoprotein cholesterol (LDL-C) concentration will be recorded from routine clinical laboratory testing conducted as part of routine clinical re-examination and reported in millimoles per liter (mmol/L).
No additional blood sample will be collected solely for this study.
Change from baseline will be calculated as the value at approximately 3 months after baseline minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in High-Density Lipoprotein Cholesterol (HDL-C) Concentration
Временное ограничение: Baseline and approximately 3 months after baseline
|
High-density lipoprotein cholesterol (HDL-C) concentration will be recorded from routine clinical laboratory testing conducted as part of routine clinical re-examination and reported in millimoles per liter (mmol/L).
No additional blood sample will be collected solely for this study.
Change from baseline will be calculated as the value at approximately 3 months after baseline minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Alanine Aminotransferase (ALT) Activity
Временное ограничение: Baseline and approximately 3 months after baseline
|
Alanine aminotransferase (ALT) activity will be recorded from routine clinical laboratory testing conducted as part of routine clinical re-examination and reported in units per liter (U/L).
No additional blood sample will be collected solely for this study.
Change from baseline will be calculated as the value at approximately 3 months after baseline minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Aspartate Aminotransferase (AST) Activity
Временное ограничение: Baseline and approximately 3 months after baseline
|
Aspartate aminotransferase (AST) activity will be recorded from routine clinical laboratory testing conducted as part of routine clinical re-examination and reported in units per liter (U/L).
No additional blood sample will be collected solely for this study.
Change from baseline will be calculated as the value at approximately 3 months after baseline minus the baseline value.
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Baseline and approximately 3 months after baseline
|
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Change in Serum Uric Acid Concentration
Временное ограничение: Baseline and approximately 3 months after baseline
|
Serum uric acid concentration will be recorded from routine clinical laboratory testing conducted as part of routine clinical re-examination and reported in micromoles per liter (μmol/L).
No additional blood sample will be collected solely for this study.
Change from baseline will be calculated as the value at approximately 3 months after baseline minus the baseline value.
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Baseline and approximately 3 months after baseline
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Yubing Wang, Nanjing Children's Hospital
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 июля 2026 г.
Первичное завершение (Оцененный)
30 апреля 2027 г.
Завершение исследования (Оцененный)
30 июня 2027 г.
Даты регистрации исследования
Первый отправленный
10 сентября 2026 г.
Впервые представлено, что соответствует критериям контроля качества
16 сентября 2026 г.
Первый опубликованный (Действительный)
17 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
17 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
16 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 202604063-2
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .