Women Exercising: Active, and Learning Together for Health (WEALTH) Trial 2.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Physiologic Stress
研究概览
简要总结
The goal of this randomized controlled clinical trial is to determine the efficacy of a 6 week dance fitness intervention has on reducing objective, physiological stress in women between the ages of 30 and 60. It will also learn about its ability to improve mental and psychological health outcomes. The main questions is aims to answer is : 1) To what extent can a 6-week dance fitness intervention improve the health of women? 2) Are intervention effects sustained 4 weeks after the intervention has ended? Researchers will compare the intervention condition to a waitlist control condition. Participants will: 1) complete baseline assessments, 2) complete a six week dance fitness program or complete their usual routine for six weeks, 3) complete immediate post-intervention assessments, and 4) complete follow-up assessments four weeks after the post-intervention assessments.
详细描述
In the United States, one in five adults (approximately 58 million) is estimated to be living with a mental illness. However, the rate of mental illness is higher in women (27.2%) compared to males (18.1%). High levels of stress, depression, and anxiety are the most reported mental health disorders among women. One protective factor against poor mental health outcomes is participation in physical activity. However, women have been underrepresented in health science studies, precluding us from understanding the best means of promoting physical activity and associated health benefits through intervention.
The Women Exercising, Active, and Learning Together for Health 2.0 (WEALTH 2.0) intervention seeks to understand how a dance fitness intervention may best serve women. This study aims to test the efficacy of a two-arm, group-based physical activity intervention for reducing stress and improving mental health outcomes in midlife women. The two major aims include 1) understanding the immediate- and long-term efficacy of the intervention on physiologic stress and mental health outcomes and 2) determining the associations between change in stress and change in secondary health outcomes. The investigative team will recruit 60 women between the ages of 30 and 60 years to participate in our study. Women will be randomly assigned to an in-person intervention condition or a waitlist control group. Classes will be offered twice per week for 30 minutes for a toal of 6-weeks in the Dance Studio of the Oschner Wellness Center here on the LSU Main Campus by a certified group fitness instructor. Classes will consist of dance fitness content and resistance training exercises to align with the U.S. physical activity guidelines.
The primary outcome of this intervention is physiologically assessed stress (saliva). Secondary outcomes will include perceived stress (questionnaire), depression symptomology (questionnaire), anxiety (questionnaire), body image (questionnaire), social health (questionnaire), intervention adherence (self-report logs), body composition (DEXA scans), and device-measured physical activity (7-day accelerometer protocols). All outcomes will be assessed at three time points: Week 0 (baseline), Week 6 (immediate post-intervention), and Week 10 (follow-up assessment). Achieving the goals of this project will 1) expand upon our previous successful feasibility study, 2) demonstrate the impact of a physical activity intervention and its effect on stress and mental health, 3) better understand the inter-relationships among stress, mental health, and health behaviors/outcomes in midlife women.
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
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 30-60
- •body mass index >18
- •employed at Louisiana State University
排除标准
- •age <18 or >60
- •students at Louisiana State University
- •Not employed at Louisiana State University
- •body mass index <18
结局指标
主要结局
Physiologic Stress
时间窗: From enrollment to the end of the follow-up period at week 10
The primary outcome variable of physiologic stress will be assessed through markers in saliva. Samples will be collected using the non-invasive commercially available Salimetrics polyester Oral Swab (SOS) technology (Salimetrics, CA, USA), which has been validated for salivary hormone, sIgA, and alpha-amylase measurements. Immediately after waking up but before getting out of bed, participants will be asked to place one SOS under their tongue for 3 minutes before returning it to the provided vial. Immediately after the first timed saliva collection, participants will be asked to place a second SOS pad under their tongue until full saliva saturation is obtained.
次要结局
- Depression(From enrollment to the end of the follow-up period at week 10)
- Anxiety(From enrollment to the end of the follow-up period at week 10)
- Social Health(From enrollment to the end of the follow-up period at week 10)
- Perceived Stress(From enrollment to the end of the follow-up period at week 10)
- Body Image(From enrollment to the end of the follow-up period at week 10)
- Device Measured Physical Activity(From enrollment to the end of the follow-up period at week 10)