Nudge-Based Exercise Intervention for Adolescents With Obesity
16 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
140
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Chenxin Gan
- Número de telefone: 18205049751
- E-mail: gcx5101@163.com
Locais de estudo
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Jiangsu
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Nanjing, Jiangsu, China
- Recrutamento
- Nanjing Children's Hospital
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Contato:
- Chenxin Gan
- Número de telefone: 18205049751
- E-mail: gcx5101@163.com
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Investigador principal:
- Yubing Wang
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Body Mass Index (BMI)
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Total Sedentary Time
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in Fasting Blood Glucose
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Yubing Wang, Nanjing Children's Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de julho de 2026
Conclusão Primária (Estimado)
30 de abril de 2027
Conclusão do estudo (Estimado)
30 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
10 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de setembro de 2026
Primeira postagem (Real)
17 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202604063-2
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