Nudge-Based Exercise Intervention for Adolescents With Obesity
16 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
140
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Chenxin Gan
- Numéro de téléphone: 18205049751
- E-mail: gcx5101@163.com
Lieux d'étude
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Jiangsu
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Nanjing, Jiangsu, Chine
- Recrutement
- Nanjing Children's Hospital
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Contact:
- Chenxin Gan
- Numéro de téléphone: 18205049751
- E-mail: gcx5101@163.com
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Chercheur principal:
- Yubing Wang
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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.
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Body Mass Index (BMI)
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Total Sedentary Time
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Fasting Blood Glucose
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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)
Délai: Baseline and approximately 3 months after baseline
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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)
Délai: 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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: 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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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
Délai: Baseline and approximately 3 months after baseline
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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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Yubing Wang, Nanjing Children's Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2026
Achèvement primaire (Estimé)
30 avril 2027
Achèvement de l'étude (Estimé)
30 juin 2027
Dates d'inscription aux études
Première soumission
10 septembre 2026
Première soumission répondant aux critères de contrôle qualité
16 septembre 2026
Première publication (Réel)
17 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202604063-2
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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