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Prepare - How to Reach Women of Reproductive Age With Obesity to Support Weight Loss Before Pregnancy?

2020年7月29日 更新者:Harvard Pilgrim Health Care

How to Reach Women of Reproductive Age With Obesity to Support Weight Loss Before Pregnancy?

Researchers at Harvard Pilgrim Health Care Institute and Massachusetts General Hospital are conducting a study to learn more about how best to reach out to women (age 18-45) who are thinking about a pregnancy in the next couple of years and currently have a BMI greater than 30 kg/m2.

Interested participants will be asked to complete a 15-minute survey. The survey will ask some more questions about their prior reproductive health history, opinions and experiences regarding lifestyle, weight and health. After completing the survey, researchers would like to arrange a time to complete a 20- to 30-minute semi-structured interview about their perceived health in the process of planning pregnancy.

研究概览

地位

完全的

详细说明

The purpose of this study is to learn the best ways to support healthful behaviors and weight loss prior to pregnancy. Researchers are also interested in what motivates or prevents women of reproductive age from engaging in a structured weight loss program. Participants will be asked for no more than an hour of their time to complete a brief survey and participate in an interview. This study is being conducted by Harvard Pilgrim Health Care Institute. This study is being paid for by the Nutrition Obesity Research Center at Harvard (NORCH).

At the end of the interview, study staff will also talk to participants about the opportunity to be referred to the Mass General Weight Center if they are interested in participating in a program now being offered there.

If participants elect to participate in a program at the weight center, researchers would then like to complete 2 more short interviews with these participants about that process. The first will be about 5 minutes and will take place just after the initial Weight Center Orientation, and the last will be about 10 minutes and take place after 3 months of participation. During this final interview, researchers will ask for participant opinions about the program that they have just participated in.

研究类型

观察性的

注册 (实际的)

99

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Harvard Pilgrim Health Care Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Participants will include patients in Massachusetts General Hospital clinical settings, users of the Ovia fertility app as well as members of the community who may see ads posted in local newspapers.

描述

Inclusion Criteria:

  • Women aged 18-45 years old,
  • BMI>30 mg/m2,
  • thinking about planning a pregnancy in the next 2 years

Exclusion Criteria:

  • Previous bariatric surgery,
  • currently pregnant

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Initial survey and interview (Aim 2)
Participants in Aim 2 will be asked to complete an initial 15-minute survey and 20-30 minute semi-structured interview. The purpose of this study is to learn the best ways to support healthful behaviors and weight loss prior to pregnancy. Researchers are also interested in what motivates or prevents women of reproductive age from engaging in a structured weight loss program.
Formal weight loss program (Aim 3)
Participants in Aim 3 have expressed interest in referral to the Mass General Weight Center. The purpose of this study is to learn what motivates or prevents women of reproductive age from engaging in a structured weight loss program. Researchers will ask for no more than a half hour of participant's time to complete a 5- minute interview following Orientation at the Weight Center and another 10-minute interview after a participant has participated in a program offered at the Weight Center.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Participant recruitment feasibility
大体时间:1 year
Feasibility determined by compiling the actual number of participants recruited divided by the time and resources necessary to achieve that number participants for each recruitment strategy.
1 year

次要结果测量

结果测量
措施说明
大体时间
Participants' attitudes and perceptions of their own health risks with regard to weight-related complications
大体时间:1 year
Participants are asked to measure levels of agreement/disagreement with their perceived health risk for ten weight related complications as follows: developing developing diabetes, developing cancer, developing heart disease, developing high blood pressure, developing high cholesterol, being able to get pregnant, having diabetes during pregnancy, having high blood pressure during pregnancy, having a large baby, and having to undergo a c-section
1 year
Participant adherence during a structured weight loss program.
大体时间:1 year
Participants' attendance is recorded throughout the duration of a 12-week weight loss program. Successful adherents will have attended >70% of meetings.
1 year
Participants' estimated time frame before trying to get pregnant and willingness to delay their pregnancy attempt in order to complete a structured weight loss program.
大体时间:1 year
Participants are interviewed to assess their current time frame before actively trying to get pregnant. Participants are also asked if they are willing to delay a pregnancy attempt and if so, for how long.
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Marie-France Hivert, MD, MMSc、Harvard Pilgrim Health Care Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月25日

初级完成 (实际的)

2019年8月31日

研究完成 (实际的)

2020年6月15日

研究注册日期

首次提交

2018年3月1日

首先提交符合 QC 标准的

2018年9月6日

首次发布 (实际的)

2018年9月10日

研究记录更新

最后更新发布 (实际的)

2020年7月30日

上次提交的符合 QC 标准的更新

2020年7月29日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1105007

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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