Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study is to learn if women gain weight using progestin-only methods of contraception and if so, how much. The investigators will look at users of two progestin-only methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of users of a non-hormonal method, the copper intrauterine device.
The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition will increase more than the copper-IUD users. The investigators will collect body composition data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and activity using validated questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants between the ages of 18 and 45 years
- •Participants starting the copper IUD or implant through their provider
- •First study visit must occur within 14 days of method insertion
排除标准
- •DMPA in the past 16 weeks
- •POPs, LNG-IUC, or the implant in the past 4 weeks
- •Thyroid disease
- •Autoimmune disease
- •Diabetes (excluding gestational)
- •History of eating disorder
- •Currently taking antidepressants for < 6 months
- •Currently taking antipsychotics
- •Currently taking oral glucocorticoids (steroids, i.e. prednisone) for more than 6 months
- •Currently breastfeeding
- •Less than 6 months post-partum
结局指标
主要结局
Weight
时间窗: Baseline and 12 months
Compare changes in body weight and BMI measurements
次要结局
- Body composition(Baseline and 12 months)