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Nudge-Based Exercise Intervention for Adolescents With Obesity

16. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Rekruttering
        • Nanjing Children's Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Yubing Wang

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Mass Index (BMI)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Sedentary Time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Fasting Blood Glucose
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing Children's Hospital

Efterforskere

  • Ledende efterforsker: Yubing Wang, Nanjing Children's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Anslået)

30. april 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

10. september 2026

Først indsendt, der opfyldte QC-kriterier

16. september 2026

Først opslået (Faktiske)

17. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202604063-2

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