The Young Men's Christian Association (YMCA) Healthy Lifestyle Program for Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Time in tight range (TITR)
研究概览
简要总结
The goal of this 26 week randomized controlled clinical trial is to learn if using a real time continuous glucose monitor (CGM) in a healthy lifestyle program for adults with prediabetes at the YMCA can improve glucose levels, dietary habits and physical activity The main questions it aims to answer is
- Does use of a CGM improve the percent of time spent with glucose values between 70-140 mg/dl
- Does use of a CGM improve nutritional habits as measured by Picture Your Plate (PYP) score
- Does use of a CGM improve physical activity as measured by International Physical Activity Questionnaire (IPAQ) score
Researchers will compare individuals using real time CGM to those not using CGM
Participants will be asked to:
- attend weekly health coach sessions for 12 weeks followed by 3 monthly sessions.
- attend a YMCA class of their choice
- fill out questionnaires at baseline, 12 and 24 weeks
- have an A1c blood test at baseline, 12 and 24 weeks.
- wear a CGM.
All participants will wear a blinded CGM at baseline. The intervention group will wear a real time CGM for 24 weeks. The control group will wear a blinded CGM for 10 days at 6, 12 and 24 weeks
详细描述
BACKGROUND:
Diabetes has a significant impact on physical, social and mental well-being and causes significant morbidity and mortality in the United States. The total direct estimated costs of diagnosed diabetes have increased from $227 billion in 2012 to $307 billion in 2022.
In 2021, 38.1 million adults aged 18 years or older (14.7% of all US adults) had diabetes with a higher prevalence of 29.2% among those aged 65 years or older. An estimated 97.6 million adults had prediabetes in 2021.
The Diabetes Prevention Program (DPP) study published in 2002 clearly showed the benefit of lifestyle intervention in reducing the risk of developing type 2 diabetes by 58% compared to placebo. The Program worked particularly well for participants ages 60 and older, lowering their chances of developing type 2 diabetes by 71 percent. However, the retention rate for the DPP program has been 32% at 10 months with only 17% achieving all three goals of weight loss, physical activity ≥ 150 min per week and low fat diet. In fact, over the 20 years since the study was published, the incidence and prevalence of diabetes have dramatically increased with prediabetes affecting more than one third of the adult population. It is clear that a new approach is needed to prevent individuals with prediabetes progressing to diabetes
RATIONALE:
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 (Outcomes Assessor)
盲法说明
All study personnel will be blinded to the "blinded' CGM data until the participant completes all study visits.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •● Adults 18 years or older AND
- •A diagnosis of prediabetes as defined by:
- •Fasting glucose 100-125 mg/dl OR
- •A1c 5.7-6.4%
排除标准
- •Pregnancy
- •Previous CGM use
- •Lack of smart phone/smart device
- •Use of steroids
- •Active cancer treatment
- •Active chronic infection requiring long term use of antibiotics
- •Terminal illness
- •Dementia, mental impairment
- •Non English speaking
研究组 & 干预措施
Group 1 : Intervention with Stelo
Stelo CGM
干预措施: Real time continuous glucose monitor (Stelo) (Device)
Group 2 : control
Group 2 will only wear a blinded CGM for 10 days at 6,12 and 24 weeks
结局指标
主要结局
Time in tight range (TITR)
时间窗: Assessed at baseline, 6,12 and 24 weeks
Percent of time with glucose values in the range of 70-140 mg/dl
PYP
时间窗: Assessed at baseline, 12 and 24 weeks
Change in picture your plate (PYP) score. The score ranges from 0 to 96 with a higher score indicating a healthier diet. A score \< 40 indicates greater likelihood of an unhealthy dietary pattern with much room for improvement. A PYP score greater than 60 indicates a healthful dietary pattern, although there may be some specific eating behaviors that could be improved.
IPAQ
时间窗: Assessed at baseline, 12 and 24 weeks
Change in International Physical Activity Questionnaire (IPAQ) score. This score is reported as Metabolic Equivalent (MET) minutes/week. Values can range from 0 to 4000 with a higher value indicating more physical activity
次要结局
- A1c(baseline, 12 and 24 weeks)
- Change in waist circumference(baseline, 4,8,12,16,20 and 24 weeks)
- Change in BMI(baseline, 4,8,12,16,20 and 24 weeks)
- Change in weight(baseline, 4,8,12,16,20 and 24 weeks)
- Change in body fat percentage(baseline, 4,8,12,16,20 and 24 weeks)
研究者
Sushma Reddy, MD
Principal Investigator
Young Men's Christian Association of the Blue Water Area