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NCT Number: NCT07824453

Nudge-Based Exercise Intervention 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.

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Key information

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Children's Hospital

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Chenxin Gan

CONTACT

[email protected]

18205049751

Yubing Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Exercise Intervention

Behavioral

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.

Nudge-Based Exercise Intervention

Behavioral

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.

Primary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: 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.

  2. Change in Physical Activity

    Time frame: 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.

Secondary outcomes

  1. Change in Total Sedentary Time

    Time frame: 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.

  2. Change in Body Fat Percentage

    Time frame: 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.

  3. Change in Skeletal Muscle Mass

    Time frame: 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.

  4. Change in Exercise Self-Efficacy

    Time frame: 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.

  5. Change in Health-Related Quality of Life

    Time frame: 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.

Other outcomes

  1. Change in Fasting Blood Glucose

    Time frame: 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.

  2. Change in Fasting Insulin

    Time frame: 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.

  3. Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: 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.

  4. Change in Glycated Hemoglobin (HbA1c)

    Time frame: 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.

  5. Change in Total Cholesterol Concentration

    Time frame: 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.

  6. Change in Triglyceride Concentration

    Time frame: 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.

  7. Change in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration

    Time frame: 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.

  8. Change in High-Density Lipoprotein Cholesterol (HDL-C) Concentration

    Time frame: 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.

  9. Change in Alanine Aminotransferase (ALT) Activity

    Time frame: 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.

  10. Change in Aspartate Aminotransferase (AST) Activity

    Time frame: 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.

  11. Change in Serum Uric Acid Concentration

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenxin Gan

CONTACT

[email protected]

18205049751

Sponsors and collaborators

Lead sponsor

Nanjing Children's Hospital

Other

Registry information

Official study title

Development and Application of a Nudge-Based Exercise Program for Adolescents With Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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