ISRCTN29738990已完成未知
A single-centre, four-arm, randomised parallel trial of healthy eating, aerobic exercise and resistance training to reduce percent body fat in overweight or obese adolescents
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute0 个研究点目标入组 292 人开始时间: 2007年6月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 292
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30363954 [added 20/02/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female
- •2. Aged 14 to 18 years
- •3. Tanner stage IV or above
- •4. Body mass index (BMI) greater than or equal to 95th percentile for age, and gender (http://www.cdc.gov/growthcharts),
- •greater than or equal to 85th percentile for age/gender with any of:
- •4.1. Fasting glucose greater than or equal to 6.0 fasting
- •4.2. Two-hour plasma glucose 7.8 - 11 mmol/L after 75 G oral glucose (impaired glucose tolerance)
- •4.3. Fasting triglycerides greater than 1.7 mmol/L
- •4.4. Fasting plasma insulin greater than 105 pmol/L
- •4.5. High density lipoprotein-cholesterol (HDL-C) less than 0.9 mmol/L
- •4.6. Low density lipoprotein-cholesterol (LDL-C) greater than 3.0 mmol/L
- •4.7. Total cholesterol/HDL-C greater than 90th percentile
- •4.8. First-degree relative with type 2 diabetes
排除标准
- •1. Participation during the previous four months in a regular program of exercise or aerobic sports greater than or equal to two times per week for at least 20 minutes per session
- •2. Diabetes mellitus
- •3. Body weight over 159 kg, and/or BMI greater than 45 kg/m^2, exceeding capacity of dual energy X-ray absorptiometry (DEXA) and computed tomography (CT) machines
- •4. Use of any performance-enhancing medication
- •5. Use of any medication or herbal supplement that is likely to affect body composition, lipids or glucose metabolism
- •6. Significant weight change (increase of greater than or equal to 10%, or decrease greater than or equal to 5% of body weight during the two months before enrolment)
- •7. Uncontrolled hypertension: blood pressure (BP) greater than 150 mmHg systolic or greater than 95 mmHg diastolic BP in sitting position
- •8. Activity restrictions due to disease: unstable cardiac or pulmonary disease, significant arthritis
- •9. Other illness judged by the patient or study physician to make participation in this study inadvisable
- •10. Unwillingness/lack of availability to attend exercise and/or nutrition sessions at scheduled times and locations
- •11. Significant cognitive deficit resulting in inability to understand or comply with instructions
- •12. Pregnancy at the start of the study, or intention to become pregnant in the next year
- •13. Inability to communicate in English or French
- •14. Unwillingness of subject and/or parent/guardian to sign informed consent
研究者
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