Interventions for Adolescent Obesity
关键词
抽象
描述
This study will evaluate the short-term use of activity tracking devices and their effects on short- and long-term weight loss in adolescents. The investigators plan to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. Each participant with an activity tracking device will have the goal of reaching 10,000 steps per day, in addition to their individual fitness plan.
日期
| 最后验证: | 03/31/2018 |
| 首次提交: | 12/19/2016 |
| 提交的预估入学人数: | 12/21/2016 |
| 首次发布: | 12/27/2016 |
| 上次提交的更新: | 01/20/2020 |
| 最近更新发布: | 01/22/2020 |
| 实际学习开始日期: | 12/31/2017 |
| 预计主要完成日期: | 11/29/2018 |
| 预计完成日期: | 12/30/2018 |
状况或疾病
干预/治疗
Behavioral: Intervention
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| No Intervention: Control Participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit. | |
| Experimental: Intervention Fitbit (activity tracker) + participants will receive the clinic standard of care which includes individual assessment and management by: a pediatric gastroenterologist, a pediatric surgeon, a dietitian, and a fitness instructor who are present at every visit. | Behavioral: Intervention Fitbit Alta |
资格标准
| 有资格学习的年龄 | 12 Years 至 12 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and understand English Willingness to be randomized to any condition Exclusion Criteria: Inability to obtain informed parental consent and/or child assent Inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety Inability of the participant to speak English |
结果
主要结果指标
1. Feasibility of the pilot trial will be measured by an attrition rate of ≤50%. [18 weeks]
次要成果指标
1. Body mass index (BMI) (kg/m2) [Change from 0 to 18 weeks]
2. Weight (kg) [Change from 0 to 18 weeks]
3. Change in obesity related biomarkers [Change from 0 to 18 weeks]
