Pengembangan Model Mindful Eating Intervention Dengan Aplikasi (EATS UP) Pada Remaja Obes Dan Pengaruhnya Terhadap Komposisi Tubuh Dan Resistensi Insulin (Indonesia Language)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Body Composition
研究概览
简要总结
The goal of this experimental study is to develop and evaluate the effectiveness of a Mindful Eating Intervention (MEI) model integrated with the digital application EatsUp for improving body fat percentage among obese adolescents in Indonesia. The study aims to address the rising prevalence of adolescent obesity and its associated health risks, such as insulin resistance and cardiometabolic syndrome, by promoting mindful eating habits and healthy lifestyle behaviors.
The main questions it aims to answer are:
-
Is the MEI model valid and acceptable for use among obese adolescents?
-
Does the MEI model reduce:
-
Body fat percentage?
-
Waist-to-height ratio (WHtR)?
-
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)?
-
Does the MEI model improve eating behavior scores compared to a control group over 12 weeks?
Participants will:
- Use the EatsUp app, designed to monitor calorie intake/output and deliver mindful eating and nutrition education.
- Receive training on mindfulness-based eating practices, along with guidance on balanced nutrition and physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 15-18 years old
- •Agreed to be involved in research proven by signing informed consent and assent
- •Indicated as Obesity by BMI-Age Nutritional Status and body fat percentage
排除标准
- •Subject is on a dietary treatment or has a serious condition (e.g. chronic infectious disease, and undergoing drug therapy)
- •Subject with special needs (cannot use internet, cannot communicate normally)
研究组 & 干预措施
Nutrition and Physical Activity with Mindful Eating Intervention
The intervention group receiving nutrition and physical activity with mindful eating intervention
干预措施: Nutrition and Physical Activity Education with Mindful Eating Intervention (Behavioral)
Nutrition and Physical Activity Education
The control group receiving only nutrition and physical activity education
干预措施: Nutrition and Physical Activity Education (Behavioral)
结局指标
主要结局
Body Composition
时间窗: From enrollment to the end of intervention at 12 weeks
Body composition measured in this study are Body Mass Index for Age (BMI-Age), Waist-to-Height Ratio (WHtR), Waist Circumference, Body Fat Percentage,
Fasting Blood Sugar Levels
时间窗: From enrollment to the end of intervention at 12 weeks
Blood glucose examination is carried out after fasting for 10 - 12 hours.
Fasting Insulin Levels
时间窗: From enrollment to the end of intervention at 12 weeks
Measures the amount of insulin in the blood during fasting.
Insulin Resistance
时间窗: From enrollment to the end of intervention at 12 weeks
HOMA-IR (Homeostatic Model Assessment for Insulin Resistance): Calculated using fasting glucose and insulin levels, with a threshold value (≥3.8) indicating insulin resistance.
Mindful Eating Score
时间窗: From enrollment to the end of intervention at 12 weeks
Mindful eating is assessed based on 5 domains: distraction, disinhibition, awareness, external cues, and emotional eating. Mindful Eating Questionnaire is scored by adding up responses to each item and dividing by the total number of items answered. The resulting score ranges from 1 to 4, with higher scores indicating more mindful eating.
Eating Behavior
时间窗: From enrollment to the end of intervention at 12 weeks
Psychosocial factors and attitudes that influence eating behavior such as food choices, dieting, and the presence of eating disorders measured using Adolescent Food Habit Checklist (AFHC)
Binge Eating
时间窗: From enrollment to the end of intervention at 12 weeks
Eating behavior disorder where a person tends to overeat and has difficulty controlling it is assessed from a total score of 16 statements using Binge Eating Scale Questionnaire. The total score ranges from 0 to 46, with higher scores correlating with more frequent and severe binge eating behaviors. Based on the total scores, it can be classified into distinct severity categories as follows: 1. Low Binge-Eating: Scores of 17 or lower; 2. Mild to Moderate Binge-Eating: Scores ranging from 18 to 26; 3. Severe Binge-Eating: Scores of 27 or higher, indicating a high frequency and severity of binge-eating symptoms.
Sleep Quality
时间窗: From enrollment to the end of intervention at 12 weeks
Sleep can produce a feeling of being fit, assessed based on duration, latency, efficiency and sleep disturbance as measured using the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Physical Activity Level
时间窗: From enrollment to the end of intervention at 12 weeks
Measurement of physical activity during the last 7 days using the International Physical Activity Questionnaire for Adolescent (IPAQ-A)
次要结局
未报告次要终点
研究者
Aryono Hendarto
Professor
Indonesia University