Nudge-Based Exercise Intervention for Adolescents With Obesity

NCT07824453 | Recruiting

• 1 other identifier: 202604063-2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and approximately 3 months after baseline

Secondary Outcomes (5)

• Change in Total Sedentary Time

  Baseline and approximately 3 months after baseline

• Change in Body Fat Percentage

  Baseline and approximately 3 months after baseline

• Change in Skeletal Muscle Mass

  Baseline and approximately 3 months after baseline

• Change in Exercise Self-Efficacy

  Baseline and approximately 3 months after baseline

• Change in Health-Related Quality of Life

  Baseline and approximately 3 months after baseline

Other Outcomes (11)

• Change in Fasting Blood Glucose

  Baseline and approximately 3 months after baseline

• Change in Fasting Insulin

  Baseline and approximately 3 months after baseline

• Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  Baseline and approximately 3 months after baseline

Study Arms (2)

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.

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.

Behavioral: Nudge-Based Exercise Intervention

Interventions

Standard Exercise Intervention BEHAVIORAL

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.

Standard Exercise Intervention

Nudge-Based Exercise Intervention BEHAVIORAL

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.

Nudge-Based Exercise Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

Nanjing Children's Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yubing Wang

  Nanjing Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenxin Gan

CONTACT

18205049751; gcx5101@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

CN (1)