Women's Lifestyle and Sleep Intervention for Prediabetes and Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in body mass index
研究概览
简要总结
This pilot study aims to determine whether adding a sleep extension and sleep hygiene intervention to an existing lifestyle improvement program improves its efficacy for weight loss in those at risk for diabetes and cardiovascular disease. Half of the participants will receive the Centers for Disease Control's standard PreventT2 program and half of the participants will receive the same program with an additional sleep intervention.
详细描述
The goal of this pilot study is to determine whether the efficacy of an existing lifestyle improvement program can be increased by adding a sleep extension and sleep hygiene intervention. Improved sleep can improve weight loss through two possible routes: lessening fatigue may potentiate physical activity (PA), and decreasing appetite may potentiate diet improvements. A sample of 24-30 women will be assigned to either the Centers for Disease Control's (CDC's) standard PreventT2 program or the same program with an additional integrated sleep intervention. Both programs will involve 8 group sessions administered over 3 months, and all women will be followed for a total of 6 months. The primary outcome is weight loss, and secondary outcomes include sleep quality and duration, physical activity, caloric intake, and physiological indicators of cardiovascular and diabetes risk (HbA1c, HOMA-IR, lipids, blood pressure). The combined program has the potential to significantly improve weight loss in those at risk for diabetes and cardiovascular disease (CVD).
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female (or self-identify as female)
- •Age 30-70 years
- •BMI 25-38 (or 23-38 if Asian or other Pacific Islander)
- •Time in bed <= 7 hours on a typical weeknight
- •Meets diagnostic criteria for prediabetes and/or metabolic syndrome
排除标准
- •No regular access to telephone or email (for maintaining contact);
- •No access to smartphone, tablet, or laptop computer (for using Fitbit);
- •Having a condition that limits physical activity, such as brisk walking;
- •Having a diagnosis of type 1 or type 2 diabetes or been previously treated with diabetes medications;
- •Having a cardiac event or cardiac surgery in the past year;
- •Having a metabolic condition that prevents weight loss;
- •Working night shift (Midnight - 4 AM)
- •Inability to complete the baseline assessment (REDCap survey and Fitbit tracking of activity, diet, and sleep for 7 days)
研究组 & 干预措施
Active Control
Participants in the active control group will receive 8 group sessions of the CDC's PreventT2 program.
干预措施: CDC's PreventT2 Program (Behavioral)
Experimental
Participants in the experimental group will receive 8 group sessions of the CDC's PreventT2 Program with Added Sleep Content designed to extend and improve sleep.
干预措施: CDC's PreventT2 Program with Added Sleep Content (Behavioral)
结局指标
主要结局
Change in body mass index
时间窗: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Body mass index is calculated as the participant's body weight divided by the square of their height.
次要结局
- Change in physical activity (objective)(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in physical activity (self-report)(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in sleep duration (objective)(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in sleep quality (self-report)(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in caloric intake(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in leptin levels(Baseline and 6 weeks after start of intervention)
- Change in self-assessed general health(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in self-reported dietary intake(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in HbA1c(Baseline and 3 months, and 6 months after start of intervention)
- Change in Fasting Plasma Glucose (FPG)(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline and 6 weeks after start of intervention)
- Change in blood pressure(Baseline and 6 weeks, 3 months, and 6 months after start of intervention)
- Change in waist circumference(Baseline and 6 months after start of intervention)