NCT01664026撤回不适用
A 6-Month, Randomized Study to Evaluate the Efficacy of a Web-based Lifestyle Modification Program With and Without Telephone Counseling Support
Clínica Bazterrica1 个研究点 分布在 1 个国家开始时间: 2012年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in body weight from randomization to 6 months
研究概览
简要总结
To evaluate the effect of a 6-month web-based lifestyle modification program with and without telephone counseling versus usual care in obese patients with cardiovascular risk factors on:
- Weight Loss
- Waist circumference; blood pressure; total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol; glucose and hemoglobin A1c; C-reactive protein.
- Physical activity and eating habits
- Quality of life
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 25-70 years of age
- •Obese (BMI ≥ 30 kg/m2 and <40 kg/m2)
- •At least 2 cardiovascular risk factors (diabetes, hypertension or dyslipidemia) i) Hypertension defined by a history of hypertension, treatment of hypertension or BP values >140/90 mmHg in two consecutive office visits ii) High cholesterol defined by an LDL-C ≥130 mg/dL and/or HDL-C <40 mg/dL and triglycerides ≥150 mg/dL iii) Type 2 Diabetes Mellitus defined by a history of diabetes, treatment of diabetes or fasting glucose ≥126 mg/dL in two consecutive office visits
- •Participant must be willing and able to provide written informed consent
- •Participant must be willing and able to comply with study related procedures
- •Participant must have access to Internet and e-mail
排除标准
- •Stage 1 or 2 on Patient Activation Measures tool
- •Weight change of more than 5 kg during the 3 months preceding the screening visit
- •History of bariatric surgery
- •Fasting Plasma Glucose at screening > 250 mg/dL (> 13.9 mmol/L)
- •Hemoglobin A1c at screening >8.5%
- •Treatment of type 2 diabetes with insulin (except for history of intermittent acute use, no more than 2 weeks usage in previous 6 months)
- •Uncontrolled or inadequately controlled hypertension at the time of screening with blood pressure >160/100 mmHg
- •Secondary hypertension
- •Changes in lipid, blood pressure or diabetes modifying agents including introduction, change in dose or cessation in the 3 months prior to Screening Visit
- •Personal history of coronary heart disease, congestive heart failure, serious arrhythmias and stroke
- •Cardiovascular, hepatic, neurological, endocrine disease, active malignant tumor or other major systemic disease making implementation of the protocol or interpretation of the study results difficult.
- •Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study
- •Presence of history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer
- •Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
- •Use of any investigational agent (drug, biologic, device) within 3 months prior to screening
研究组 & 干预措施
Control
No Intervention
Subjects assigned to the usual care group will receive general lifestyle recommendations as per their country standards of care.
Web
Experimental
Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.
干预措施: Web-based lifestyle modification (Behavioral)
Web+
Experimental
Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.
干预措施: Web-based lifestyle modification + (Behavioral)
结局指标
主要结局
Change in body weight from randomization to 6 months
时间窗: 6 months
次要结局
- Changes in blood pressure(6 months)
- Changes in glycemic parameters (glucose and hemoglobin A1c)(6 months)
- Changes in lipid parameters (total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol)(6 months)
- Changes in C-reactive protein(6 months)
- Changes in waist circumference(6 months)
研究者
Arnaldo Angelino
Jefe de Prevencion y Rehabilitacion
Clínica Bazterrica
研究点 (1)
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