Nudge-Based Exercise Intervention for Adolescents With Obesity
16. září 2026 aktualizováno: 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.
Přehled studie
Postavení
Postavení
Nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
140
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Chenxin Gan
- Telefonní číslo: 18205049751
- E-mail: gcx5101@163.com
Studijní místa
-
-
Jiangsu
-
Nanjing, Jiangsu, Čína
- Nábor
- Nanjing Children's Hospital
-
Kontakt:
- Chenxin Gan
- Telefonní číslo: 18205049751
- E-mail: gcx5101@163.com
-
Vrchní vyšetřovatel:
- Yubing Wang
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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Aktivní komparátor: 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.
|
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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Body Mass Index (BMI)
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Total Sedentary Time
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Change in Exercise Self-Efficacy
Časové okno: 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
|
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Change in Health-Related Quality of Life
Časové okno: 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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Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Fasting Blood Glucose
Časové okno: 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
Časové okno: 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
|
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Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Časové okno: 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)
Časové okno: 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
|
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Change in Total Cholesterol Concentration
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Baseline and approximately 3 months after baseline
|
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Change in Aspartate Aminotransferase (AST) Activity
Časové okno: 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
|
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Change in Serum Uric Acid Concentration
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Yubing Wang, Nanjing Children's Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
1. července 2026
Primární dokončení (Odhadovaný)
Primární dokončení
30. dubna 2027
Dokončení studie (Odhadovaný)
Dokončení studie
30. června 2027
Termíny zápisu do studia
První předloženo
První předloženo
10. září 2026
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
16. září 2026
První zveřejněno (Aktuální)
První zveřejněno
17. září 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
17. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. září 2026
Naposledy ověřeno
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 202604063-2
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Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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