Development and Application of a Nudge-Based Exercise Program for Adolescents With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard Exercise Intervention (Behavioral)
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.
干预措施: Nudge-Based Exercise Intervention (Behavioral)
结局指标
主要结局
Change in Body Mass Index (BMI)
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Chenxin Gan
Graduate Student
Affiliated Hospital of Nanjing University of Chinese Medicine