Pediatric Obesity
Conditions
Brief summary
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.
Interventions
BEHAVIORALStandard Exercise Intervention
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.
BEHAVIORALNudge-Based Exercise Intervention
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.
Sponsors
Nanjing Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | 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. |
| Change in Physical Activity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Sedentary Time | 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. |
| Change in Body Fat Percentage | 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. |
| Change in Skeletal Muscle Mass | 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. |
| Change in Exercise Self-Efficacy | 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. |
| Change in Health-Related Quality of Life | 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. |
Countries
China
Contacts
CONTACTChenxin Gan
PRINCIPAL_INVESTIGATORYubing Wang
Nanjing Children's Hospital
Outcome results
None listed