Targeting Obesity and Blood Pressure in Urban Youth(Consortium Title: Childhood Obesity Prevention and Treatment Research [COPTR] and Site Project Name IMPACT (Ideas Moving Parents and Adolescents to Change Together).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Slope of Body Mass Index (BMI)
研究概览
简要总结
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled "Targeting Obesity and Blood Pressure in Urban Youth". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together).
The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes.
The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years.
详细描述
The IMPACT trial will involve a 3-arm randomized controlled trial of three behavioral and educational interventions: (1) HealthyCHANGE, a behavioral approach focusing on building skills and increasing intrinsic motivation (based on cognitive-behavioral theory with motivational interviewing components); (2) SystemCHANGE, an innovative behavioral approach focusing on system re-design of the family environment and daily routines (based on social-ecological and personal process improvement theories); and (3) education-only (representing usual care, called Tools4CHANGE).
In the main trial, approximately half of the children will also be in schools that take part in the We Run This City (WRTC)Marathon program, a school-based fitness program administered by the YMCA, and half will be in schools that do not take part in the WRTC program.
This study will assess the impact of the interventions on the main trial's (1) primary outcome, Change in Body Mass Index (BMI). (2) secondary outcomes including diet, physical activity, sedentary behavior, sleep, blood pressure, cardiovascular risk, body composition, fitness, and quality of life (3) mediators including : child's self-efficacy, social support, motivation, family problem solving ability, systems thinking, and self-regulation;(4) moderators including: socioeconomic status, demographic factors, environmental factors, personal and psychosocial characteristics of child and parent.
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
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Students entering the 6th grade who are found at the standard school screenings to be overweight or obese
- •(BMI 85th- 94th percentile or > 95th percentile for age/sex respectively)
排除标准
- •Taking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones)
- •Inability to understand English
- •Stage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria)
- •Severe behavioral problems that preclude group participation (as reported by parent/guardian)
- •Child involvement in another weight management program
- •Family expectation to move from the region within 1 year
- •The presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease)
结局指标
主要结局
Slope of Body Mass Index (BMI)
时间窗: Baseline, 12 mos, 24 mos and 36 mos
BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
次要结局
- Dietary Intake- Calories Per Day(Baseline, 12 mos, 24 mos and 36 mos)
- Blood Pressure(Baseline, 12 mos, 24 mos and 36 mos)
- Physical Activity([Baseline, 12 mos, 24 mos and 36 mos])
- Sleep([Baseline, 12 mos, 24 mos and 36 mos])
- Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol(Baseline, 12 mos, 24 mos and 36 mos)
- Body Composition- BMI Percentile(Baseline, 12 mos, 24 mos and 36 mos)
- Fitness(Baseline, 12 mos, 24 mos and 36 mos)
- Quality of Life- Perceived Stress([Baseline, 12 mos, 24 mos and 36 mos])
- Dietary Intake- Percent Calories From Fat(Baseline, 12 months, 24 months, 36 months)
- Dietary Intake- Fruit and Vegetable Servings(Baseline, 12 months, 24 months, 36 months)
- Dietary Intake- Sodium(Baseline, 12 months, 24 months, 36 months)
- Cardiometabolic Factors- Hemoglobin A1c([Baseline, 12 mos, 24 mos, 36 mos])
- Cardiometabolic Factors- High-sensitivity C-reactive Protein([Baseline, 12 mos, 24 mos, 36 mos])
- Cardiometabolic Factors- Insulin([Baseline, 12 mos, 24 mos, 36 mos])
- Cardiometabolic Factors- HOMA-IR([Baseline, 12 mos, 24 mos, 36 mos])
- Body Composition- Waist-to-height Ratio([Baseline, 12 mos, 24 mos, 36 mos])
- Body Composition- Waist Circumference([Baseline, 12 mos, 24 mos, 36 mos])
- Body Composition- Percent Body Fat([Baseline, 12 mos, 24 mos, 36 mos])
研究者
Elaine Borawski
Angela Bowen Williamson Professor of Community Nutrition, Director, Prevention Research Center for Healthy Neighborhoods
Case Western Reserve University