Improving Weight Loss in Healthy Adults With Overweight and Obesity: An Artificial Intelligence-assisted Dietary Prediction and Prevention System With Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Height
研究概览
简要总结
This study aims to examine the effectiveness of a novel dietary lapse prediction and prevention self-regulation app called the eating behaviour trigger-response inhibition program (eTRIP), and the addition of continuous glucose monitoring (CGM), on healthy eating and weight loss in people with overweight and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are 21-65 years old
- •have BMI ≥23 kg/m2
- •can comprehend the English language
- •uses a smartphone that can download apps
- •are willing to perform continuous glucose monitoring (CGM) using the Dexcom continuous glucose monitoring system
- •willing to travel to the National University of Singapore (NUS)
- •able to provide informed consent
排除标准
- •are using/intend to use other apps for weight loss;
- •are pregnant or lactating (as it would affect weight change and caloric needs)
- •are diagnosed severe mental disorders (e.g. major depressive disorder and schizophrenia)
- •are on prescribed meal replacements or pharmacotherapy
- •have serious medical conditions
- •are scheduled for any kind of surgery within the next 6 months
研究组 & 干预措施
Control
Control group will not receive any smartphone application or continuous glucose monitoring.
eTRIP smartphone application
Intervention group 1 involves using the eating behaviour trigger-response inhibition program(eTRIP) smartphone application for 10 weeks, where participants will need to take pictures of their food items as part of their food logging and may also engage with app-based activities to build self-regulatory skills in sticking to their weight loss plans. Additionally, participants will also apply a continuous glucose monitoring (CGM) sensor on their arm and taught how to scan the CGM sensor so that they can monitor their glucose levels for the first 10 days.
干预措施: eTRIP (Behavioral)
FatSecret smartphone application
Intervention group 2 involves using the FatSecret smartphone application for participants to monitor their calorie intake, without any continuous glucose monitoring.
干预措施: FatSecret (Other)
结局指标
主要结局
Height
时间窗: At weeks 0, 10 and 24.
Taken using a wall mounted measuring tape.
Weight
时间窗: At weeks 0, 10 and 24.
Taken using InBody 120
Waist Circumference
时间窗: At weeks 0, 10 and 24.
Taken using a measuring tape.
BMI
时间窗: At weeks 0, 10 and 24.
Taken using InBody 120
Self regulation of Eating Behaviour Questionnaire (SREBQ)
时间窗: At weeks 0, 10 and 24.
The Self-Regulation of Eating Behaviour Questionnaire (SREBQ) is a validated self-administered instrument used to assess individuals' self-regulation in relation to eating behavior. It evaluates the extent to which individuals monitor, control, and regulate their eating behaviors in everyday contexts. Higher scores indicate greater self-regulation of eating behavior.
次要结局
- Patient Health Questionnaire-2 (PHQ-2)(At weeks 0, 10 and 24.)
- Euro Quality of life 5 Dimensions-5 Levels (EQ-5D-5L)(At weeks 0, 10 and 24.)
- Generalized Anxiety Disorder 2-item (GAD-2)(At weeks 0, 10 and 24.)
- Percentage Body Fat(At weeks 0, 10 and 24.)
- Body Fat Mass(At weeks 0, 10 and 24.)
- Three Factor Eating Questionnaire (TFEQ)(At weeks 0, 10 and 24.)
- International Physical Activity Questionnaire Short-Form (IPAQ-SF)(At weeks 0, 10 and 24.)
- Self-Report Behavioural Automaticity Index (SRBAI)(At weeks 0, 10 and 24.)
- Consideration of Future Consequences Scale (CFCS-6)(At weeks 0, 10 and 24.)
- Skeletal Muscle Mass(At weeks 0,10 and 24.)
- Visceral Fat Level(At weeks 0, 10 and 24.)
- Big Five Inventory - 44 item (BFI-44)(At weeks 0, 10 and 24.)
研究者
Jocelyn Chew
Assistant Professor
National University Health System, Singapore