Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Dietary Intake as Measured by Percent Energy From Fat
研究概览
简要总结
The purpose of this study is to examine whether the use of genetic test information and/or health coaching in patient risk counseling for heart disease and diabetes affect health behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and Air Force retiree patients.
Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk markers. Participants in the two groups that include health coaching will be assigned to a trained certified health coach for a period of 6 months. The duration of the study is 12 months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys at 6 weeks and 3 month time points.
详细描述
This study will examine the impact of providing genetic CHD and T2D risk information, with or without a supportive behavioral intervention, on promoting risk-reducing behaviors and improving clinical outcomes. In short, using a 4-group (2X2) randomized controlled trial (RCT) design, this study will determine whether incorporating multiple-marker genetic testing into risk counseling for CHD and T2D, coupled with a health coaching intervention will lead to greater changes in physical fitness, health behaviors, risk status and clinical outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and AF retiree patients (N=400).
The study will address the following task objectives:
- Determine the main and interactive effects of multiple-marker genetic risk information incorporated into standard CHD and T2D risk counseling (Standard Risk Assessment, or SRA) and an established, structured telephonic health coaching intervention on health behavior change (diet, exercise habits, smoking cessation) over 12 months, with a focus on ADAF patients, as well as their beneficiaries and retirees.
- Determine the main and interactive effects of genetic risk information incorporated into standard CHD and T2D risk counseling and a telephonic health coaching intervention on clinical outcomes (fasting blood glucose, blood pressure, BMI, LDL, triglycerides, total cholesterol, AF composite fitness scores) over 12 months in this AF cohort.
Given the lack of RCTs on the effects of differing genetic test results, such as false reassurance and genetic determinism, we will also pursue a third, exploratory task objective: 3. Examine the differential effects of level of CHD and T2D genetic risk (# of risk alleles) on behavior change (diet, exercise habits, smoking cessation) and AF fitness scores at 12 months post baseline.
Baseline data collection: After screening and informed consent, height and weight, SBP, waist circumference, current lab results (FPG, total cholesterol, triglycerides, LDL, HbA1c, and HDL) and current PHA (physical health assessment) data with fitness scores ( for active duty personnel only) will be obtained from the medical records. Subjects randomized to the two genetic arms will have blood collected for testing of investigational CHD and T2D risk markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years
- •Willingness and ability to provide informed consent
- •Have an active email address and internet access
- •Physical exam in the last 12 months with the following documented evaluations in EMR (Electronic Medical record):
- •Blood pressure
- •Height and weight
- •Fasting blood glucose or Hemoglobin A1C (HbA1c)
- •Lipid panel (TC, LDL, HDL, TRIG) with at least one of them outside of the normal ranges defined as:
- •i.BMI ≥ 25 kg/m2 (BMI = weight [kg] / ht [m]2)
- •ii.FPG > 100 AND ≤ 125 mg/dL
- •iii.HbA1c > 5.7% ≤ 6.4%
- •iv.SBP ≥ 130 mmHg
- •v.TC ≥ 200 mg/dL
- •vi.TRIG ≥ 150 mg/dL
- •vii.LDL ≥ 129 mg/dL
排除标准
- •Projected deployment in the upcoming 6 months
- •Diagnosed type 2 diabetes
- •Diagnosed coronary heart disease (CHD) -(Myocardial Infarction, or documented CHD)
- •Inability to ambulate or participate in physical activity
- •Serious chronic disease related complications or conditions that could significantly affect study outcomes [currently treated cancer, renal failure, cardiovascular accident (CVA) with residual effects on functioning
- •Current participation in another research study
- •Spouse, partner or other household member already participating in this study protocol
研究组 & 干预措施
Standard Risk Assessment (SRA)
Subjects will receive a standard risk assessment only for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
干预措施: Standard risk assessment (Behavioral)
SRA plus Health Coaching (HC)
In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months
干预措施: Health coaching (Behavioral)
SRA plus Health Coaching (HC)
In addition to the standard risk assessment for CHD and T2D subjects will receive health coaching intervention for 6 months
干预措施: Standard risk assessment (Behavioral)
SRA plus Genetic Risk Counseling (GRC)
In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
干预措施: Genetic risk counseling (Genetic)
SRA plus Genetic Risk Counseling (GRC)
In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
干预措施: Standard risk assessment (Behavioral)
SRA+HC+GRC
In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
干预措施: Health coaching (Behavioral)
SRA+HC+GRC
In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
干预措施: Genetic risk counseling (Genetic)
SRA+HC+GRC
In addition to the standard risk assessment for CHD and T2D subjects will receive genetic risk counseling and health coaching intervention for 6 months.
干预措施: Standard risk assessment (Behavioral)
结局指标
主要结局
Dietary Intake as Measured by Percent Energy From Fat
时间窗: 12 months
Dietary intake as measured by percent energy from fat, adjusted for baseline
Dietary Intake as Measured by Daily Grams of Fiber
时间窗: 12 months
Dietary intake as measured by daily grams of fiber, adjusted for baseline
Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)
时间窗: 12 months
The Stanford Brief Activity Survey is a 2-item survey that assesses two categories of physical activity - work and leisure. There are five options for degree of activity to choose from in each of the two areas of activity. Activity categories (inactive, light-intensity activity, moderate-intensity activity, hard-intensity activity, and very hard-intensity) are represented in a table of different patterns. Degree of work activity is represented on the vertical axis and degree of leisure activity is represented on the horizontal axis. The overall activity level category is determined by where the two responses intersect.
Smoking Status
时间窗: 12 months
Medication Adherence as Measured by Morisky Adherence Survey MMAS8
时间窗: 12 months
Scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score between 6 \< 8 medium adherence and a score of 8 high adherence.
Weight
时间窗: 12 months
Weight in kg
Waist Circumference
时间窗: 12 months
Waist circumference in cm
Systolic Blood Pressure
时间窗: 12 months
Systolic blood pressure in mmHg
Diastolic Blood Pressure
时间窗: 12 months
Diastolic blood pressure in mmHg
High-density Lipoprotein (HDL)
时间窗: 12 months
High-density lipoprotein (HDL) in mg/dL
Low-density Lipoprotein (LDL)
时间窗: 12 months
Low-density lipoprotein (LDL) in mg/dL
Triglycerides
时间窗: 12 months
Triglycerides in mg/dL
次要结局
- Fasting Blood Glucose(12 months)
- Body Mass Index (BMI)(12 months)
- Total Cholesterol(12 months)
- AF Composite Fitness Scores(12 months)
- Framingham Risk Score (FRS)(12 months)
- Diabetes Risk Score(12 months)
- Perceived Risk for Coronary Heart Disease (CHD)(6 months)
- Perceived Risk for Type 2 Diabetes (T2D)(6 months)
- Patient Activation Score(12 months)
- Stages of Change(6 months)
- Depression, as Measured by the Beck Depression Inventory (BDI)(6 months)
- Unmanaged Stress as Measured by the Perceived Stress Scale (PSS)(6 months)
- Social Isolation(6 months)