Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in BMI z-scores
研究概览
简要总结
The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle modification program focusing on dietary modification and exercise. Parents will be randomized into control and motivational interviewing-based intervention groups. The primary hypothesis is that adolescents whose parents are in the intervention group will have improved compliance, weight loss and health outcomes compared with adolescents whose parents do not receive the intervention.
详细描述
Adolescents will participate in a 6-month intensive lifestyle modification that includes a structured exercise program, nutrition education and dietary modification and behavioral support, followed by a 6-month maintenance phase with monthly booster sessions. Parents will be randomized to participate in 4 dedicated "pre-treatment" parent psychoeducational sessions vs. control (no psychoeducational sessions). The sessions will explore parents' feelings about participation in a weight management program, explore their reasons for wanting to make behavioral changes, and enhance motivation. All parents will participate in monthly parent support groups while their adolescents are participating in the intervention phase of the study. The 6-month adolescent intervention will include biweekly sessions with a registered dietitian for dietary education; biweekly interactive group discussion sessions on topics pertaining to motivation, strategies for changing health behaviors, setting and keeping goals and dealing with peer pressure; and exercise sessions three times a week with 30 minutes of cardiovascular exercise and 30 minutes of strength training each session. Comprehensive assessments, including nutrition, behavior and exercise assessments, laboratory work, body composition measurements and medical assessments will be conducted at baseline, 6 months and 12 months.
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
- None
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 11 - 16; BMI > 85th percentile; one parent or guardian committed to participate in protocol; -
排除标准
- •Previous enrollment in IRB3354, IRB3008 or HM11113; Underlying genetic, neurological, endocrine or metabolic condition that preclude weight loss with conventional diet and exercise programs; Weight greater than 400 pounds, Pregnancy in female subjects; Inability to understand study instructions due to language barrier or mental disability; Primary residence outside a 30 mile radius of study location.
结局指标
主要结局
Change in BMI z-scores
时间窗: 12 weeks, 6 months and 12 months
次要结局
- Changes in blood pressure(12 weeks, 6 months and 12 months)
- Changes in ECG parameters(12 weeks and 6 months)
- Changes in body composition of participating parents(12 weeks, 6 months and 12 months)
- Changes in body composition(12 weeks, 6 months and 1 year)
- Changes in quality of life scores(12 weeks, 6 months and 12 months)
- Changes in BMI(12 weeks, 6 months and 12 months)
- Changes in serum lipids(12 weeks, 6 months and 12 months)
- Changes in insulin sensitivity(12 weeks, 6 months and 12 months)
- Changes in fitness measures(12 weeks, 6 months and 12 months)
- Changes I dietary intake(12 weeks, 6 months and 12 months)
- Changes in BMI of participating parents(12 weeks, 6 months and 12 months)