Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in body weight (kg)
研究概览
简要总结
Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives.
The purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old
- •Obese based on World Health Organization criteria (BMI>30kg/m2)
- •Receiving primary care from and referred by a provider at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA
- •Able to understand and sign an informed consent document
- •Able to communicate with the investigator and understand the requirements of this study
- •Exclusion Criteria
- •Primary care provider determines that the individual is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- •Primary care provider determines that the individual has inadequate cognitive function to participate in either active intervention curricula
- •Women who are pregnant, who are planning to become pregnant in the next two years, or who become pregnant during the study
- •Women who are breastfeeding
- •Prisoners
- •Individuals who are planning to have bariatric surgery or who have had bariatric surgery in the past two years
- •Individuals with uncontrolled hypertension (systolic blood pressure (SBP) >165, diastolic blood pressure (DBP) >100)
- •Individuals with an edematous state that interferes with body weight assessment (e.g., severe congestive heart failure, end- stage renal disease, or ascites),
- •Individuals already using weight loss therapy
- •Individuals with an inability to learn adequately from English language audio-taped materials
- •Individuals with a lack of high-speed Internet access (Internet access will be based on participant perception; for example, participants could use computers belonging to friends, relatives, or libraries if they feel that they can access them regularly)
- •Individuals without access to a scale
- •Individuals unable to attend an Orientation session at Hershey Medical Center in Hershey, PA
排除标准
- 未提供
结局指标
主要结局
Change in body weight (kg)
时间窗: 6 months, 12 months, 18 months
次要结局
- Change in blood pressure (mm Hg)(6 months, 12 months, 18 months)
- Percentage of body weight lost(6 months, 12 months, 18 months)
- Change in health-related quality of life as determined by the RAND-36 PCS or MCS(6 months, 12 months, 18 months)
- Change in physical activity (steps per day)(6 months, 12 months, 18 months)
- Change in dietary pattern(6 months, 12 months, 18 months)
- Satisfaction with program(6 months, 12 months, 18 months)
研究者
Kathleen McTigue
Assistant Professor
University of Pittsburgh