Impact of Augmented Care at the Worksite for Diabetes Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Percent Weight Change
研究概览
简要总结
The purpose of the study was to evaluate the impact of augmented care at the worksite through a lifestyle intervention for diabetes prevention among employees with prediabetes who were slower to respond to a standard diabetes prevention intervention.
详细描述
Employees at the Ohio State University (OSU) with prediabetes participated in a standard lifestyle intervention (Group Lifestyle Balance) for diabetes prevention. Participants who did not achieve >2.5% weight loss at week 5 of the intervention were stratified to the augmented intervention (Group Lifestyle Balance Plus) at week 5. The impact of the augmented intervention compared to the standard intervention was determined at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helped participants achieve and maintain weight loss similar to those who received the standard intervention.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Benefits-eligible Ohio State University (OSU) employee
- •Intend to be employed by OSU through the length of the follow-up phase
- •Body mass index: >24 kg/m^2 non-Asians; >22 kg/m^2 Asians
- •Fasting blood glucose of 100-125 mg/dL or an A1c of 5.7-6.4%
- •Blood glucose of 110-199 (if non-fasting in previous 2 hours)
排除标准
- •Blood glucose level of ≥ 200 mg/dL
- •Conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension)
- •Chronic use of medications that affect blood glucose levels (i.e., corticosteroids)
- •Concurrent participation in a structured weight loss program or counseling for bariatric surgery
- •Pregnant or breastfeeding
- •Score of ≥ 10 on the Patient Health Questionnaire-8 indicating moderate to severe depressive symptoms
- •Score of ≥ 27 on the Binge Eating Scale indicating the potential for binge eating
- •Unwilling to accept randomization
- •Planning to move from the area or changing employment.
结局指标
主要结局
Percent Weight Change
时间窗: 12-months and 18-months
Change in weight as measured in light clothing and shoes removed
次要结局
- Fasting Glucose(12-months and 18-months)
研究者
Carla Miller
Professor (current affiliation at Indiana University)
Indiana University