Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Adherence of CGM use
研究概览
简要总结
The goal of this clinical trial is to determine the potential effectiveness of adding Continuous Glucose Monitoring to a personalized weight loss maintenance program in improving weight loss maintenance.
The main questions it aims to answer are:
- What is the feasibility and acceptability of wearing a continuous glucose monitoring device in people maintaining weight loss?
- Is using continuous glucose monitoring will help to change the food and physical activity behavior in people maintaining weight loss?
Participants will be randomized into control and intervention groups where the researchers will compare the effects of wearing continuous glucose monitoring devices on behavior change in both groups.
详细描述
The study is a 24-week study conducted at the University of Glasgow. It is a randomized, non-blinded, feasibility trial with 48 adults randomized into one of two groups (24 adults in each group):
- Personalized Weight Management Group (PWM): The group will receive a personalized diet and physical activity plan and five one-to-one online support meetings with a trained dietitian over the first 12 weeks of the program (in weeks 1, 2, 4, 8, and 12). The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, and physical activity). Participants will be asked to self-manage during weeks 12 - 24 and asked to maintain the diet, PA recommendations, and monitoring based on the advice and training provided in the first 12 weeks of the program.
- PWM + CGM: This group will receive the same support as the PWM group. The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, physical activity, and glucose level). In addition, participants will be provided with a CGM device and guidance on how to use this to support weight loss maintenance. They will be provided with CGM devices for the whole study duration.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years old.
- •Intentionally lost ≥5 kg within the past 6 months
- •Have a BMI of >25kg/m2 prior to weight loss
- •Have access to and be able to use a smartphone or tablet running iOS or Android and be able to use the Freestyle Libre app and MyFood24 app OR access and ability to use a telephone.
- •Participants should be willing to use CGM.
- •Participants must be able to read, understand and communicate in English
排除标准
- •Have been diagnosed with Type 1 and Type 2 Diabetes
- •Pregnant or planning pregnancy in the next 6 months, or currently breastfeeding.
- •Participants who are currently on any pharmacological treatments for weight loss or any drugs may affect body weight.
- •Participants who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy.
- •Participants with known hypersensitivity to CGM sensors.
- •Participants with any other serious medical condition, in the opinion of the investigators, would compromise their safety or adherence to the study.
- •Participants diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or purging disorder).
- •Participants who lack capacity or are unable to read or understand written or verbal instructions in English.
结局指标
主要结局
Adherence of CGM use
时间窗: 24 weeks
The proportion of days for which valid CGM data are obtained from the CGM group.
Research retention rate
时间窗: 24 weeks
Retention is the number of participants that remain till the end of the trial at the end of 24 weeks.
Research recruitment rate
时间窗: 24 weeks
The number of adults being recruited over the course of recruitment phase.
Changes in body composition
时间窗: 24 weeks
Body composition will be measured using bioelectrical impedance at Week 0, 12, 24
Changes in dietary intake
时间窗: 24 weeks
Dietary Intake monitored for 3 days at 0, 12, 24 weeks using the MyFood24 online diaries where the participants will have to log their daily dietary intake.
Changes in weight
时间窗: 24 weeks
Weight will be monitored using weight scale from baseline Week 0, Week 12 and Week 24
Changes in physical activity
时间窗: 24 weeks
Physical Activity level monitored objectively for a day using an accelerometer at 0, 12, 24 weeks.
次要结局
- Changes in biomarkers of cardio-metabolic disease risk(24 weeks)
- Qualitative evaluation of participant's experiences(24 weeks)
研究者
Nurul Zafirah Binti Mohd Hatta
Principal Investigator
University of Glasgow