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临床试验/NCT02021630
NCT02021630已完成不适用

The Collateral Impact of Bariatric Surgery on Families

Geisinger Clinic1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Weight

研究概览

简要总结

This proposal is designed to examine the impact of bariatric surgery on the health of patients and their families. The shared environment of spouses/cohabitating partners suggests that patients' families are exposed to the extensive diet and lifestyle changes required of patients following bariatric surgery.

详细描述

The specific aims of this proposal are to:

  1. Collect clinical data (e.g., weight, blood pressure, body composition, blood sample), as well as monitor physical activity and eating patterns, before and after bariatric surgery (Adults Only).
  2. Analyze clinical data, physical activity and eating patterns to determine how the health of patients and their families change after one family member completes bariatric surgery (Adults Only).
  3. Determine the feasibility of recruiting patients, spouses/partners and their children.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who receive surgery have been cleared medically and psychosocially for surgery. Thus, surgical candidacy criteria will serve as eligibility criteria for the current study for surgical patients.
  • Cohabitation with patients will be considered inclusion criteria for partners/spouses.
  • Children between the ages of ≥5 - ≤ 16, who cohabitate with the patient the majority of the time will be asked to participate by providing assent.

排除标准

  • Report current or planned use of weight loss medications (including OTC), or other weight loss strategy.
  • Report pregnancy, lactation, or plans to become pregnant during study duration.

结局指标

主要结局

Weight

时间窗: Pre-operatively, post-operatively 6 months and 12 months

次要结局

  • Percent body fat(Pre-operatively, post-operatively 6 months and 12 months)
  • Physical Activity(Pre-operatively, post-operatively 6 months and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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