The Blossom Project: "BlossomUP" Evaluating Methods to Decrease Sedentary Time in Pregnancy
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in Time Spent Sedentary
研究概览
简要总结
Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. Additionally, previous Blossom Project studies have shown that when pregnant women engage in a 20 minute walk each day, they spend significantly more time sitting in addition to longer bouts of sitting resulting in increased total sedentary time. We are going to test which method works best to decrease sitting time, and how those methods effect metabolic parameters such as insulin resistance and blood glucose. This study will consist of three groups, each utilizing a commercially available fitness tracker, Fitbit. Group 1 (SR): will reduce sedentary time by interrupting prolonged sitting. Group 2 (WALK): will reduce sedentary time via walking. Group 3 (UC): will continue on with their normal daily routine; usual care.
详细描述
Pregnant women will be recruited using mass email recruitment, fliers posted at local community settings, and at local OBGYN offices in Ames, IA. Pregnant women will be recruited between 16 and 22 weeks gestation. Interested individuals will contact the Blossom Project staff for further information.
A randomized controlled design will be used. Following baseline data collection, women will be randomized into group 1 (n=12), group 2 (n=12) or group 3 (n=12).
For this study, the goal is to have a total of 10 women in each of the three groups. With an attrition rate of 15%, investigators plan to enroll a total of 36 women. Furthermore, increased enrollment numbers will cover inconsistencies that may arise with missing or uninterpretable data.
Individuals who contact the Blossom Project will be screened for eligibility. Individuals that meet the inclusion and exclusion criteria will meet with a Blossom Project staff member to sign an informed consent form approved by the Iowa State University Institutional Review Board (ISU-IRB). A "medical consent form" (not the consent form for the study participant) will be sent to the woman's primary obstetric provider asking to confirm qualification criteria. Participants will then be asked to complete a medical history questionnaire.
Eligible participants will be asked to participate in a 6 week intervention. Participants will report to the Nutrition Wellness Research Center (NWRC) either on campus (HNSB 2021, 2022, 2023) or the facility located at 2325 North Loop Drive, Suite 6100, Ames, Iowa 50010 at the start of week 1 and week 6. Week 1 and 6 include an 8-day data collection period outlined below. Weeks 2-6 include the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Women pregnant with one fetus between 16 and 22 weeks of gestation
- •Receiving regular prenatal care, and physician documented approval to participate in this study
- •Only inactive women will be enrolled; "inactive" is defined as self-reported participation in less than 3 planned exercise sessions/week for < 30 minutes per day for at least 6 months prior to conception.
排除标准
- •History of smoking during pregnancy;
- •History of the following chronic diseases: Type 1 diabetes, cardiovascular disease or renal disease
- •Pre-pregnancy BMI > 40 kg/m2;
- •Inability to communicate due to language barrier or mental status;
- •Not having access to an UpBand compatible mobile device;
- •Any adverse reactions to armband monitors (e.g. metal allergies, electromagnetic devices)
结局指标
主要结局
Change in Time Spent Sedentary
时间窗: From baseline to final data collection (week 6)
Change in time spent sedentary as measured by data collected via ActivPAL analysis.
次要结局
- Maternal Insulin Resistance(Maternal 24th-28th week of gestation)
研究者
Christina Campbell
Associate Professor
Iowa State University