Nudge-Based Exercise Intervention for Adolescents With Obesity
ConditionPediatric Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorNanjing Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Exercise Intervention
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Standard Exercise InterventionActive comparator 1 intervention
Group B: Nudge-Based Exercise InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Body Mass Index (BMI)
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.
Time frame
Baseline and approximately 3 months after baseline2
Change in Physical Activity
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.
Time frame
Baseline and approximately 3 months after baselineSecondary outcomes
1
Change in Total Sedentary Time
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.
Time frame
Baseline and approximately 3 months after baseline2
Change in Body Fat Percentage
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.
Time frame
Baseline and approximately 3 months after baseline3
Change in Skeletal Muscle Mass
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.
Time frame
Baseline and approximately 3 months after baseline4
Change in Exercise Self-Efficacy
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.
Time frame
Baseline and approximately 3 months after baselineOther outcomes
1
Change in Fasting Blood Glucose
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.
Time frame
Baseline and approximately 3 months after baseline2
Change in Fasting Insulin
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.
Time frame
Baseline and approximately 3 months after baseline3
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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.
Time frame
Baseline and approximately 3 months after baseline4
Change in Glycated Hemoglobin (HbA1c)
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.
Time frame
Baseline and approximately 3 months after baselineSponsors and contacts
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Nanjing Children's Hospital
Lead sponsor
Affiliated Hospital of Nanjing University of Chinese Medicine
Sponsor institution
Source ClinicalTrials.gov