NCT01479062已完成不适用
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
Berkeley Analytics, Inc.2 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 339
- 试验地点
- 2
- 主要终点
- Change from baseline in diabetes risk markers
研究概览
简要总结
The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.
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)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance
- •at least one measurement of body mass index (BMI) >=27 in the past two years
- •age 40-79
- •no use of diabetes medications within the past two years
- •member of Kaiser Permanente of Northern California (KPNC) for at least 2 years
- •live in a 25 mile radius of the KPNC Research Clinic in Oakland, CA
排除标准
- •comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension
研究组 & 干预措施
participation in Alive-PD
Experimental
Alive-PD lifestyle intervention with multi-channel delivery
干预措施: Alive-PD (Behavioral)
Control
Placebo Comparator
Usual care
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Change from baseline in diabetes risk markers
时间窗: at 3 months, 6 months and one year
Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months
Change from baseline in body weight
时间窗: at 3 months, 6 months and one year
Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months
次要结局
- Change from baseline in physical activity and dietary factors(3 months and 12 months)
研究者
Gladys Block
Principal Investigator
Berkeley Analytics, Inc.
研究点 (2)
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