Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Relative percentage change in weight
研究概览
简要总结
The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for different population groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group.
*The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE).
详细描述
This project tests whether the adapted Look AHEAD Intensive Lifestyle Intervention (ILI) will result in significant weight loss when delivered through Health IT - EHR patient portal compared to a Comparison group (based on Look AHEAD DSE Comparison group). This project will be conducted in 2 stages: a formative assessment stage (Stage 1) and a clinical trial stage (Stage 2).
During Stage 1, we will modify the interactive technology-based Look AHEAD ILI that we already developed for the TARGIT study (Active Intervention group). We will also adapt the Look AHEAD Comparison condition (DSE group) for our Comparison condition. We will also optimize the protocol for acceptability in different populations and in a rural setting.
During Stage 2, we will randomly assign 250 participants to either the Comparison Group or the Active Intervention Group to address the primary aim of testing the hypothesis that a multicomponent, behavioral weight loss intervention delivered through Health IT - patient portal will lead to significantly greater weight loss 12 months after enrollment in the Active Intervention group compared with the Comparison group. Our Health IT-based intervention is potentially cost-effective and thus disseminable to any practice-based physician group with access to an EHR with a patient portal.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomized portion of this protocol will employ a blinding design so that the CHAMPS study personnel and investigators who are collecting and assessing outcome data (i.e., weight) will not know a participant's group assignment status (blinded to assignment). Neither the participants, nor the study staff who provide the intervention, will be blinded to assignment. All participants will be asked not to reveal their CHAMPS study group assignment to blinded clinic personnel. All intervention-related information will be kept separately from outcome data and will not be accessible to blinded staff.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are ≥ 16 years old
- •are overweight or obese (BMI ≥ 25 kg/m2)
- •have access to the Internet via the computer or use a cellphone with a data-plan access
- •are patients at one of the participating practice sites
- •are willing to accept a random assignment, and
- •are from different population groups (racial / ethnic minority, lower socioeconomic status, or reside in a rural location).
排除标准
- •coronary or cerebrovascular disease events or vascular procedures within the past 6 months
- •certain medical conditions that put participants at high risk of adverse events or preclude exercising
- •uncontrolled psychiatric disorders
- •current substance abuse, including heavy alcohol use ≥ 5 drinks on the same occasion for ≥ 5 days in the past 30 days
- •a history of amputation or bariatric surgery or are planning to have bariatric surgery within the next 12 months
- •current weight loss medication use
- •malignancy within the last 5 years (except skin cancer)
- •plans to move out of the area during the next year
- •current participation in another clinical trial
- •pregnancy or breast feeding or are planning to become pregnant within the next 12 months, and
- •instances judged by the investigators' and primary care providers' discretion.
结局指标
主要结局
Relative percentage change in weight
时间窗: 12 months
This is calculated for each follow-up visit as ((weight at FU visit - baseline weight) / (baseline weight)) × 100%.
次要结局
- Relationship of mutlitlevel determinants of health (screening tool) with weight change over time(12 months)
- Relationship of mutlilevel determinants of health (BRFSS) with weight change over time(12 months)
- Relationship of multilevel determinants of health (z codes) with weight change over time(12 months)