NCT04422951终止不适用
Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index From Baseline to 6 Months
研究概览
简要总结
A 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body mass index (BMI) trajectories over 6 months between 10-16-year-old children with obesity randomized to receive the wise social psychological interventions plus a usual care behavioral intervention for weight management compared to children randomized to receive additional education plus a usual care behavioral intervention.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10-16 year old children with obesity (BMI ≥ 95th percentile on the 2000 Centers for Disease Control and Prevention BMI reference) on the date of randomization. Participation in a behavioral weight control program. Standard behavioral weight control program eligibility criteria will apply: Child and at least one parent/guardian must agree to participate
排除标准
- •Medical conditions affecting growth - diagnosed with a genetic or metabolic disease/syndrome associated 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
- •Medications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone
- •Conditions limiting 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
- •Conditions 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 his/her native language
- •Unable to read, understand or complete informed consent in English or Spanish
结局指标
主要结局
Change in Body Mass Index From Baseline to 6 Months
时间窗: Change from baseline to 6 months
body mass index = weight in kilograms divided by the squared height in meters
次要结局
未报告次要终点
研究者
Thomas Robinson
Professor
Stanford University
研究点 (2)
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