Pediatric ObesityNCT07824453
Nudge-Based Exercise Intervention for Adolescents With Obesity
A study testing Standard Exercise Intervention and Nudge-Based Exercise Intervention in people with Pediatric Obesity, run by Nanjing Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Standard Exercise Intervention and Nudge-Based Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Children's Hospital
Nanjing, Jiangsu
Chenxin Gan, 18205049751, gcx5101@163.com
Yubing Wang
About this study
Official title: 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.
- Conditions
- Pediatric Obesity
- Being tested
- Standard Exercise Intervention, Nudge-Based Exercise Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Exercise InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Exercise Intervention | Active comparator | 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. Receives: Behavioral: Standard Exercise Intervention |
| Nudge-Based Exercise Intervention | Experimental | 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. Receives: Behavioral: Nudge-Based Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and approximately 3 months after baseline
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.
Measured: Baseline and approximately 3 months after baseline
Secondary outcomes (5)
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.
Measured: Baseline and approximately 3 months after baseline
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.
Measured: Baseline and approximately 3 months after baseline
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.
Measured: Baseline and approximately 3 months after baseline
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.
Measured: Baseline and approximately 3 months after baseline
Change in Health-Related Quality of Life
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.
Measured: Baseline and approximately 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenxin Gan, Affiliated Hospital of Nanjing University of Chinese Medicine
- Investigators
- Yubing Wang, Principal investigator, Nanjing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824453
- Sponsor's protocol ID
- 202604063-2
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Nudge-Based Exercise Program for Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT07824453
- Acronym / sponsor ID
- 202604063-2
- Conditions
- Pediatric Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Exercise Intervention | Active comparator | Behavioral: Standard Exercise InterventionParticipants 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. |
| Nudge-Based Exercise Intervention | Experimental | Behavioral: Nudge-Based Exercise InterventionParticipants 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. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Exercise InterventionParticipants 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. | Behavioural | Standard Exercise Intervention |
| Nudge-Based Exercise InterventionParticipants 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. | Behavioural | Nudge-Based Exercise Intervention |
Primary outcome
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.
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.
5 secondary outcomes
Change in Total Sedentary Time
Time frame: Baseline and approximately 3 months after baseline
Change in Body Fat Percentage
Time frame: Baseline and approximately 3 months after baseline
Change in Skeletal Muscle Mass
Time frame: Baseline and approximately 3 months after baseline
Change in Exercise Self-Efficacy
Time frame: Baseline and approximately 3 months after baseline
Change in Health-Related Quality of Life
Time frame: Baseline and approximately 3 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yubing Wang principal investigator
Nanjing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Exercise Intervention and Nudge-Based Exercise Intervention in people with Pediatric Obesity, run by Nanjing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenxin Gan (18205049751, gcx5101@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Baseline and approximately 3 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.