Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Weight Change From Baseline to 12 Months
研究概览
简要总结
This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and brief counseling about screening test results on weight and key health behaviors among Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood sugar levels. Participants will receive brief counseling about the results from their primary care provider or someone authorized to speak on their behalf. Participants randomly selected for the Brochure Group will review a handout from the VA National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All participants will be asked to complete a survey prior to study group assignment, immediately after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.
详细描述
An essential step in designing effective strategies to improve patient engagement in behavior change is to better understand their current levels of engagement in these behaviors and determine which factors most influence their engagement. Within and outside the Veterans Health Administration (VHA), little is known about how patients with risk factors for T2DM view their risk of developing T2DM, what these patients understand about strategies to reduce this risk, and to what degree at-risk patients are currently engaging in behaviors to prevent T2DM. This project will generate important new data in these areas and will improve the investigators' understanding of the effects of a prediabetes diagnosis and brief counseling on engagement in behaviors to prevent T2DM and mediators of these behaviors.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The investigators will recruit 315 non-diabetic Veterans receiving primary care at the Ann Arbor VA Medical Center who meet the following inclusion criteria:
- •willing to complete a HIPAA authorization form
- •no HbA1c results in previous 12 months
- •due for VA Primary Care appointment approximately 12 weeks of sending a recruitment letter and who have a body-mass index (BMI) 30 kg/m2
- •or BMI 25 kg/m2 with > 1 obesity-related condition such as:
- •hypertension
- •hyperlipidemia
- •Hypoalphalipoproteinemia
- •Coronary Artery Disease
- •Peripheral Vascular Disease
- •Hypertriglyceridemia
- •past hemoglobin A1c (HbA1c) of 5.7 - 6.4
- •past diagnosis of Impaired Fasting Glucose (IFG)
- •or Impaired Glucose Tolerance (IGT)
- •or Polycystic Ovary Syndrome (PCOS)
排除标准
- •The investigators will exclude patients who are > 75 years of age
- •are receiving chemotherapy for cancer, or have:
- •New York Heart Association Class III or IV congestive heart failure
- •pregnancy
- •Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 4 Chronic Obstructive Pulmonary Disease (COPD)
- •end-stage renal disease (ESRD)
- •cirrhosis
- •or have been hospitalized or received rehab for stroke or myocardial infarction within the past 6 months
结局指标
主要结局
Weight Change From Baseline to 12 Months
时间窗: 12 months
The primary outcome will be weight change 12 months after an HbA1c test and brief counseling or review of health promotion literature.
次要结局
- Change in Use of Medication for T2DM Prevention(3 and 12 months)
- Changes in Participation in a Weight Management Program(3 months and 12 months)
- Changes in Perception for Risk for T2DM(Baseline, 2 weeks, 3 months, and 12 months)
- Changes in Knowledge of Strategies to Prevent T2DM(2 weeks, 3 months, and 12 months)
- Changes in Motivation to Prevent T2DM(Baseline, 2 weeks, 3 months, and 12 months)
- Changes in Self-efficacy to Engage in Behaviors to Prevent T2DM(Baseline, 3 months and 12 months)
- Change in Physical Activity(Baseline, 3 months and 12 months)
- Change in Mental Health(Baseline, 2 weeks, 3 months, and 12 months)