NCT01642836已完成不适用
Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 2
- 主要终点
- body mass index trajectory (change)
研究概览
简要总结
Stanford GOALS is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children. Primary Research Question: Will a 3-year, innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based intervention to treat overweight and obese children significantly reduce BMI compared to an enhanced standard care/health and nutrition education active comparison intervention?
详细描述
Single-blind study with all outcomes assessors (data collectors) and Investigators masked (blinded) to intervention assignment. Intention-to-treat analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7-11 years of age
- •BMI greater than or equal to the 85th percentile for age and sex on the 2000 U.S. Centers for Disease Control and Prevention (CDC) BMI reference
排除标准
- •Have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated with obesity, Type 1 diabetes, Type 2 diabetes taking medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection, pregnancy);
- •Take medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
- •Have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason);
- •Have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in school for reading and writing in her native language);
- •Are unable to read, understand or complete informed consent in English or Spanish;
- •Plan to move from the San Francisco Bay Area within the next 36 months.
- •Are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the Principal Investigator.
结局指标
主要结局
body mass index trajectory (change)
时间窗: baseline, 1, 2 and 3 years
slope of measured weight in kilograms divided by the square of height in meters
次要结局
- waist circumference(baseline, 1, 2 and 3 years)
- resting heart rate(baseline, 1, 2 and 3 years)
- physical activity measured by accelerometry(baseline, 1, 2 and 3 years)
- Typical household Television (TV) use(baseline, 1, 2, and 3 years)
- Percent of energy intake from fat(baseline, 1, 2, and 3 years)
- Added sugar(baseline, 1, 2, and 3 years)
- Percent median BMI for age and sex (calculated from BMI)(baseline, 1, 2, and 3 years)
- fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, Alanine Aminotransferase (ALT)(baseline, 1, 2 and 3 years)
- triceps skinfold thickness(baseline, 1, 2 and 3 years)
- Percent body fat (estimated)(baseline, 1, 2, and 3 years)
- Average total daily energy intake(baseline, 1, 2 and 3 years)
- Weight Concerns(baseline, 1, 2 and 3 years)
- School performance(baseline, 1, 2 and 3 years)
- Parent/guardian reported physical activity(baseline, 1, 2, and 3 years)
- Waist-to-Height Ratio(baseline, 1, 2 and 3 years)
- screen time and other sedentary behaviors(baseline, 1, 2 and 3 years)
- Children's sleep habits(baseline, 1, 2 and 3 years)
- Parent/guardian health literacy(baseline, 1 and 2 years)
- resting blood pressure(baseline, 1, 2 and 3 years)
- Depressive symptoms(baseline, 1, 2 and 3 years)
- Implicit theories(baseline, 1, 2, and 3 years)
- Parent/guardian weight(baseline, 1, 2, and 3 years)
- Parent/guardian body mass index(baseline, 1, 2, and 3 years)
- Eating with screens(baseline, 1, 2, and 3 years)
- Parent/guardian waist circumference(baseline, 1, 2, and 3 years)
研究者
Thomas Robinson
Professor of Pediatrics and of Medicine
Stanford University
研究点 (2)
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