Nudge-Based Exercise Intervention for Adolescents With Obesity
16 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Status
Rekrutacyjny
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Szacowany)
Zapisy
140
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Chenxin Gan
- Numer telefonu: 18205049751
- E-mail: gcx5101@163.com
Lokalizacje studiów
-
-
Jiangsu
-
Nanjing, Jiangsu, Chiny
- Rekrutacyjny
- Nanjing Children's Hospital
-
Kontakt:
- Chenxin Gan
- Numer telefonu: 18205049751
- E-mail: gcx5101@163.com
-
Główny śledczy:
- Yubing Wang
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
2
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Aktywny komparator: 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.
|
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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Body Mass Index (BMI)
Ramy czasowe: 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
|
|
Change in Physical Activity
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Total Sedentary Time
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Body Fat Percentage
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Skeletal Muscle Mass
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Exercise Self-Efficacy
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Health-Related Quality of Life
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Fasting Blood Glucose
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Fasting Insulin
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Glycated Hemoglobin (HbA1c)
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Total Cholesterol Concentration
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Triglyceride Concentration
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in High-Density Lipoprotein Cholesterol (HDL-C) Concentration
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Alanine Aminotransferase (ALT) Activity
Ramy czasowe: 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
|
|
Change in Aspartate Aminotransferase (AST) Activity
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
|
Change in Serum Uric Acid Concentration
Ramy czasowe: 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.
|
Baseline and approximately 3 months after baseline
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Yubing Wang, Nanjing Children's Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
1 lipca 2026
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
30 kwietnia 2027
Ukończenie studiów (Szacowany)
Ukończenie studiów
30 czerwca 2027
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
10 września 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
16 września 2026
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
17 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
17 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 września 2026
Ostatnia weryfikacja
Ostatnia weryfikacja
1 września 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 202604063-2
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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