Feasibility of an internet-based study of time-to-pregnancy in the United States

在美国基于互联网的怀孕时间研究的可行性

• 批准号: 8444099
• 负责人: LAUREN A WISE
• 金额: $ 21.72万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-01-15 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8444099
• 关键词: 21 year old; Advertisements; Advertising; Affect; African American; Antidepressive Agents; Behavioral; Beverages; Birth; Black Tea; Body Temperature; Body mass index; Caffeine; Central obesity; Cervical; Coffee; Cohort Studies; Computer software; Computers; Conceptions; Couples; Data; Data Analyses; Data Collection; Denmark; Economic Burden; Enrollment; Epidemiologic Methods; Epidemiology; Feasibility Studies; Female; Fertility; Frequencies; Green tea; Health; Hispanics; Infant; Infertility; Intake; Internet; Life Style; Link; Liquid substance; Mails; Massachusetts; Measures; Medical History; Menstrual cycle; Menstruation; Methodology; Methods; Minority; Monitor; Obesity; Online Systems; Overweight; Ovulation; Participant; Patient Self-Report; Pattern; Physical activity; Population; Pregnancy; Pregnant Women; Prevalence; Probability; Protocols documentation; Public Health; Questionnaires; Randomized; Records; Recruitment Activity; Registries; Research; Research Personnel; Risk Factors; Running; Selection Bias; Services; Severity of illness; Social Network; Tea; Testing; Time; Time Factors; Time Study; United States; Woman; aged; base; cohort; cost effective; data registry; design; follow-up; improved; kinetosome; male; modifiable risk; novel; pregnant; programs; prospective; public health relevance; reproductive; social; social networking website; success; waist circumference; web site; willingness

DESCRIPTION (provided by investigator): About 10-15% of couples suffer from infertility and its prevalence is increasing in the United States. Use of infertility services constitutes a major economic burden, and success rates of treatment are relatively low. We propose to conduct an internet-based feasibility study of risk factors for delayed time-to-pregnancy (TTP), a sensitive indicator of a couple's fertility. With targeted internet advertisements on FACEBOOK (popular social- networking website) and other social- and health-related websites, we will recruit a cohort of 2,500 female residents of Massachusetts aged 21-44 years who are planning a pregnancy. To increase minority enrollment, we will oversample African American (20%) and Hispanic (15%) women. After a short run-in period to verify a participant's identity and willingness to participate in a year-long study, participants will be followed using web-based questionnaires every 8 weeks for 12 months or until clinically-recognized pregnancy occurs, whichever comes first. The male partners of female participants will be asked to complete a web- based baseline questionnaire on lifestyle and medical history. Half of enrolled women will be randomized at baseline to receive free access to web-based menstrual charting software (FertilityFriend.com), available to them via both computer and smartphone. The primary aim of the study will be to assess the feasibility, validity, and efficiency of using the internet for recruitment, follow-up, and data collection. Secondarily, it will evaluate several potential risk factors for delayed TTP, including caffeine, anthropometric factors, physical activity, and antidepressant use. Thirdly, it will assess whether use of the web-based menstrual charting software increases cohort retention and shortens TTP. In a subset of women who conceive and deliver births during the first 12 months of the study, we will link questionnaire data with birth registry data from the Massachusetts Department of Public Health Registry of Vital Records. Registry data will be used to validate self-reported TTP and other questionnaire data (e.g., prepregnancy body mass index). We have given priority to common risk factors for which existing studies of their relation to TTP are inconclusive. The proposed prospective design is novel because most studies of fecundability have evaluated the TTP retrospectively among women who become pregnant, a method prone to selection and recall biases. Moreover, no previous TTP study has evaluated the impact of incorporating web-based menstrual charting software into its protocol. The internet will allow us to identify women planning a pregnancy, a challenging population to target using traditional epidemiologic methods. Recently, our research team demonstrated that internet-based methods are an efficient and cost-effective means of recruitment and follow-up in a prospective cohort study of TTP in Denmark. However, the feasibility of these methods remains to be tested in the United States. Such a design could have far-ranging implications for the practice of epidemiology.

描述（由研究者提供）：大约 10-15% 的夫妇患有不孕症，并且在美国，不孕症的患病率正在增加。使用不孕不育服务构成了重大的经济负担，并且治疗的成功率相对较低。我们建议对怀孕时间延迟（TTP）的风险因素进行基于互联网的可行性研究，TTP 是夫妻生育能力的敏感指标。通过在 FACEBOOK（流行社交网站）和其他社交和健康相关网站上投放有针对性的互联网广告，我们将招募 2,500 名计划怀孕的马萨诸塞州 21-44 岁女性居民。为了增加少数族裔入学率，我们将对非裔美国 (20%) 和西班牙裔 (15%) 女性进行过度抽样。经过短暂的磨合期以验证参与者的身份和参与为期一年的研究的意愿后，将在 12 个月内每 8 周使用网络问卷对参与者进行跟踪，或者直到临床认可的怀孕发生（以先到者为准）。女性参与者的男性伴侣将被要求填写一份关于生活方式和病史的基于网络的基线调查问卷。一半的登记女性将在基线时被随机分配，以免费使用基于网络的月经图表软件（FertilityFriend.com），她们可以通过计算机和智能手机使用该软件。该研究的主要目的是评估使用互联网进行招募、随访和数据收集的可行性、有效性和效率。其次，它将评估延迟 TTP 的几个潜在风险因素，包括咖啡因、人体测量因素、体力活动和抗抑郁药物的使用。第三，它将评估使用基于网络的月经图表软件是否可以提高队列保留率并缩短 TTP。对于在研究的前 12 个月内怀孕和分娩的女性子集，我们将把问卷数据与马萨诸塞州公共卫生部生命记录登记处的出生登记数据联系起来。登记数据将用于验证自我报告的 TTP 和其他问卷数据（例如孕前体重指数）。我们优先考虑常见的风险因素，但现有的关于这些因素与 TTP 关系的研究尚无定论。所提出的前瞻性设计是新颖的，因为大多数生育力研究都回顾性评估了怀孕女性的 TTP，这种方法容易出现选择和回忆偏差。此外，之前的 TTP 研究还没有评估将基于网络的月经图表软件纳入其协议的影响。互联网将使我们能够识别计划怀孕的女性，这是使用传统流行病学方法难以瞄准的目标人群。最近，我们的研究团队在丹麦进行的一项 TTP 前瞻性队列研究中证明，基于互联网的方法是一种有效且具有成本效益的招募和随访手段。不过，这些方法的可行性还有待美国的检验。这样的设计可能会对流行病学实践产生深远的影响。