The Blossom Project: "Be Well" Behavioral Wellness Study in Pregnancy to Prevent Excessive Gestational Weight Gain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Maternal Body Weight Change
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. The aim of this study is to provide a lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent excessive gestational weight gain, decrease postpartum weight retention, and improve mental well-being compared to "usual care" using a randomized controlled design in pregnant women. Participants in the intervention group will receive behavioral lifestyle counseling and take part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week 14 of their pregnancy to child birth. Participants in the "usual care" group (control) will not receive any lifestyle counseling. Data collected from this group will be used to compare the effectiveness of the lifestyle intervention. Unlike many studies examining diet and physical activity factors alone, this study evaluates additional psychosocial factors such as psychological health, self-efficacy, competence, motivation and barriers that may influence excessive gestational weight gain. In addition, the Self-Determination Theory framework will be used to measure how motivation and motivational interviewing strategies can help explain changes in volitional behavior.
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 prior to their 14th week of 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 the intervention group (n=30) or control (n=30).
For this study, the goal is to have a total of 30 women in the intervention group and 30 in the control. With an attrition rate of 20% investigators plan to enroll 37 women per group. 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 complete a maximum of four data collection periods. 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 beginning and end of each of the four data collection periods. A "visit" or "data collection period" is defined as 8 days. There are 3 data collection periods during pregnancy (visits 1-3) and one post-partum visit (visit 4). Visit 4 is not an 8-day data collection period and will take no more than 90 minutes at the NWRC.
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
- •Pregnant women between the ages of 18-45 with a pre-pregnancy BMI between 18.5-35.0 kg/m2 will be recruited for this study.
- •Qualified pregnant women include those participating in a low-active or sedentary lifestyle defined as <3 30-minute exercise sessions per week and therefore, are not currently meeting physical activity guidelines during pregnancy.
- •Participants will need to have qualification criteria confirmed by their medical provider prior to beginning the first data collection period.
排除标准
- •Pregnant beyond 14 weeks gestation
- •Multiple fetuses
- •History of smoking during pregnancy
- •History of gestational diabetes mellitus, pre-eclampsia, or chronic disease (e.g. Type 1 diabetes, Type 2 diabetes, heart disease, renal disease, or untreated thyroid conditions)
- •Inability to comprehend the information shared during the informed consent process
- •Any adverse reactions to armband monitors (e.g. metal allergies, electromagnetic devices)
研究组 & 干预措施
Behavioral Lifestyle counseling
Intervention group participants will take part in behavioral lifestyle counseling provided by a Registered Dietitian Nutritionist from week 14 of gestation through childbirth.
干预措施: Behavioral Lifestyle counseling (Behavioral)
Control
Participants in the control arm will receive no form of lifestyle intervention.
干预措施: Control (Other)
结局指标
主要结局
Maternal Body Weight Change
时间窗: From 14 weeks of gestation through 2 months post partum
Gestational weight gain as measured by last pre-delivery weight minus self-reported pre-pregnancy weight. Maternal weight will be measured at each routine prenatal appointment and plotted on the IOM pregnancy weight gain chart. Body composition changes measured by BodPod at baseline and 2 months postpartum.
次要结局
- Maternal Insulin Resistance(Maternal 26th-28th week of gestation)
- Postpartum Weight Retention(From 14 weeks of gestation through 2 months post partum)
- Maternal Postpartum Depression and Perceived Quality of Life(Baseline through 2 months post partum)
研究者
LBuckingham
Dr. Christina Campbell, Associate Professor
Iowa State University