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Nudge-Based Exercise Intervention for Adolescents With Obesity

16 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Werving
        • Nanjing Children's Hospital
        • Contact:
        • Hoofdonderzoeker:
          • Yubing Wang

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: Standard 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.
Experimenteel: 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.
Gedragsmatig: Nudge-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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Body Mass Index (BMI)
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Physical Activity
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Total Sedentary Time
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Body Fat Percentage
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Skeletal Muscle Mass
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Exercise Self-Efficacy
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Health-Related Quality of Life
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Fasting Blood Glucose
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Fasting Insulin
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Glycated Hemoglobin (HbA1c)
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Total Cholesterol Concentration
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Triglyceride Concentration
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Low-Density Lipoprotein Cholesterol (LDL-C) Concentration
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in High-Density Lipoprotein Cholesterol (HDL-C) Concentration
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Alanine Aminotransferase (ALT) Activity
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Aspartate Aminotransferase (AST) Activity
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline
Change in Serum Uric Acid Concentration
Tijdsspanne: 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.
Baseline and approximately 3 months after baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nanjing Children's Hospital

Onderzoekers

  • Hoofdonderzoeker: Yubing Wang, Nanjing Children's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juli 2026

Primaire voltooiing (Geschat)

30 april 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

10 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 september 2026

Eerst geplaatst (Werkelijk)

17 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202604063-2

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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