Louisiana State University Health Care Services Division (LSUHCSD) Tele-Health Projects: Weight Loss in Chronic Disease Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 6
- 主要终点
- Change in Waist Circumference
研究概览
简要总结
This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension.
详细描述
This study will assess the effect of in-home tele-health monitoring on health outcomes for LSUHCSD chronic disease, overweight or obese patients diagnosed with type II diabetes or hypertension. Primary emphasis will be on assessing the effect of tele-health home monitoring combined with motivational telephone coaching on weight loss and waist circumference as compared to self-directed, home monitoring alone, and telephone coaching alone. Secondary outcomes such as blood pressure, Hemoglobin A1c (HbA1c), fasting blood sugar, and cholesterol will be examined as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 yrs old
- •BMI ≥ 25 kg/m2 and waist circumference > 40 inches (men)/ 35 inches (women)
- •Weight ≤ 500lbs
- •At least one of the following:
- •Fasting blood sugar > 100 mg/dL at any point and/or taking medications for diabetes And/Or
- •Resting blood pressure > 130/90 mm Hg at any point and/or taking medications for hypertension
- •Not involved in regular physical activity or weight loss management programs
- •Capable of being physically active
- •Physically able to use in-home equipment (or presence of a household member who can assist the subject in equipment use)
- •Currently-working conventional telephone line at primary residence
- •Grounded electrical power supply at primary residence
- •Have been in LSU HCSD system for 6 months and anticipate remaining in the LSU HCSD patient population for the next 6 months
排除标准
- •A history of drug abuse in the last year, or excess alcohol consumption (40g/day)6
- •Currently dieting or engaging in any activity with the goal of losing weight
- •Significant weight loss or weight gain in the past year (> 50 lbs) or current use of weight loss medications
- •History of gastrointestinal bypass or other bariatric surgery in the last 3 years
- •Diagnosis of congestive heart failure
- •Under treatment for end-stage renal disease or end-stage liver disease
- •History of major organ transplant
- •History of cancers requiring treatment in the past 5 years with anything but excellent prognosis
- •Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders
- •Pregnant or plan on becoming pregnant in the next 12 months.
- •Lack support from health care provider or family members.
- •Current member of household participating in study
- •Factors that may limit adherence to intervention or affect conduct of the trial.
- •Unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment.
- •Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
结局指标
主要结局
Change in Waist Circumference
时间窗: five-month follow-up compared to baseline
Waist circumference at five-month follow-up minus waist circumference at baseline. Waist circumference is measured in centimeters.
Change in Body Weight
时间窗: five-month follow-up compared to baseline
Body weight at five-month follow-up minus baseline body weight. Body weight is measured in pounds
次要结局
- Change in Systolic Blood Pressure(Systolic blood pressure (mmHg) at five months minus systolic blood pressure at baseline.)
- Change in Diastolic Blood Pressure(Diastolic blood pressure (mmHg) at five months minus diastolic blood pressure at baseline.)
- Change in HbA1c(five months)
- Change in Triglycerides(five months)
- Change in Total Cholesterol(five months)
- Change in Fasting Plasma Glucose(five months)